Octasa medication
19. Ms D complains the Trust advised her father’s GP that Octasa was a suitable medication. She says this is contraindicated in patients with blood clotting abnormalities like he had. She says Mr D was already taking warfarin to thin his blood and so the two should not have been prescribed together.
20. As a result, Ms D says this was the reason for her father’s admission to hospital in November 2021. She says he suffered an internal bleed caused by the two medications.
21. We were sorry to hear Ms D felt this advice was what caused her father’s inpatient admission. We note her observation that the British National Formulary (BNF) guidelines state mesalamine (Octasa) is contraindicated in patients with blood clotting abnormalities.
22. To address Ms D’s concerns on this matter, we reviewed the complaint file and Mr D’s relevant medical records. We discussed the records with our gastroenterologist adviser, who directed us to the drugs.com website for guidance on this matter.
23. We have considered the website has been updated after the events in this complaint. We have seen the website refers to medical literature from 1998 and 2001 in its recommendations. We are also aware mesalamine has been listed in the BNF since around the same time. Based on this, we consider we can use the BNF 2022 and drugs.com website to inform us on what should have happened in this case.
24. That website notes some authorities (such as BNF) consider the use of mesalamine with anticoagulants to be contraindicated. The website states clinical data of this is lacking. This is particularly regarding the effects on other oral anticoagulants.
25. Under advice for professionals, it states taking a mesalamine (Octasa) and warfarin may increase or decrease the deficiency of prothrombin (a protein converted into active thrombin during coagulation) in the blood. It says the mechanism of this interaction is unknown.
26. The guidance therefore recommends patients receiving mesalamine along with an anticoagulant should be closely monitored and the warfarin dosage adjusted accordingly following initiation, change of dosage, or discontinuation of mesalamine. Patients should be advised to promptly report signs of bleeding or blood clots.
27. Our review of the medical records found that on 22 September 2021, a consultant gastroenterologist diagnosed Mr D with benign colonic polyp and colitis. They advised Mr D’s GP to start him on Balsalazide 2.25gm three times a day (TDS) for six weeks and then drop to 1.4gm twice a day (BD) long term. Balsalazide is a medication used to treat UC in adults.
28. On 8 October, Mr D’s GP wrote to advise they had prescribed Octasa modified release (MR) 800mg tablets as an alternative to Balsalazide, as it was unavailable in the community. They asked the Trust’s consultant to confirm their approval of the change.
29. On 12 October, the consultant documented that the change was OK with them. Our gastroenterologist adviser told us this advice aligned with clinical standards.
30. They explained it is safe to prescribe mesalamine preparations such as Octasa to patients on warfarin. This is because Octasa and Balsalazide are both preparations designed to deliver 5-amino salicylic acid (mesalamine) to the colon’s lining.
31. For patients on warfarin, Octasa and Balsalazide can affect the international normalised ratio (INR), which is a clotting measure doctors use to see if people are on the correct dose of warfarin. Therefore, if INR is affected, there may be a need to adjust the warfarin dose when a new medication such as Octasa is started.
32. In this case, the Trust’s consultant gastroenterologist confirmed the switch from Balsalazide to Octasa was OK. This is in line with relevant national guidelines, as the effects of taking Balsalazide and Octasa are similar. The drugs.com website indicates, until additional information is available, clinicians should closely monitor patients also taking anticoagulant. The guidelines do not advise against taking the two together.
33. We note Mr D was admitted with PR bleeding on 11 November. This decision to admit is in line with advice for patients, as it would have allowed for closer monitoring of Mr D.
34. We have found no failings in the Trust’s advice to switch to Octasa. We hope this offers reassurance to Ms D that the Trust acted in line with national guidelines.
Bowel disease management from November 2021
35. Ms D says the Trust failed to manage her father’s bowel disease from November 2021. As a result, she says his symptoms progressed and he suffered unnecessarily. She says her father sadly spent his time in hospital traumatised and distressed. She says he went from being completely independent to not being able to walk.
36. It must have been difficult for Ms D to see her father so distressed. We were sorry to hear how she says this impacted him both physically and emotionally. To address this part of the complaint, we reviewed the medical records from between November 2021 and June 2022. We discussed them with our advisers.
37. Our gastroenterologist adviser commented on the best medication to treat Mr D’s bowel disease. They explained infliximab (an anti-tumour necrosis factor (TNF) drug used to help stop inflammation) is strongly recommended for salvage therapy (treatment used when standard options fail) in the ECCO guidelines.
38. Our gastroenterologist adviser told us salvage therapy treats a patient in severe relapse (the disease is flaring). It is for patients where there is a worry they will have a perforation of the colon, which carries a high risk of death. These patients will often go for emergency bowel removal. Clinicians will look at how severe a patient’s relapse is based on certain criteria and will look to use salvage therapy to save the patient’s colon.
39. Recommendation 12 of the ECCO guidelines states ‘we recommend treatment with anti-tumour necrosis factor (TNF) agents (infliximab, adalimumab, and golimumab) to induce remission in patients with moderate to severe ulcerative colitis who have inadequate response or intolerance to conventional therapy [strong recommendation, moderate-quality evidence].’
40. The ECCO guidelines caution the use of infliximab in elderly inflammatory bowel disease (IBD) patients due to an increased risk of severe infection. However, several guidelines published prior to and following the ECCO guidelines argue previous trials have underrepresented people over 60 years. Study A found anti-TNF therapy did not disproportionately increase the risk of serious adverse events in older adults with IBD.
41. The Trust gave its comments Mr D did not meet the Oxford criteria for salvage therapy. This research suggests after three days of intravenous steroids, patients with more than eight bowel movements or a C-Reactive Protein (CRP) >45mg/L and a stool frequency of between three and eight bowel movements, should be considered for salvage therapy.
42. CRP is a protein produced by the liver. It serves as a marker for inflammation in the body. Under recommendation 15, the ECCO guidelines recommend ustekinumab for the induction of remission in patients with moderate to severe UC.
43. The Trust admitted Mr D with a PR bleed on 11 November 2021. Medical notes from 16 November indicate the Trust was treating this as a flare up of UC. They also note a switch from warfarin to apixaban (an anti-coagulant medication used to treat and prevent blood clots).
44. The gastroenterology team reviewed Mr D on 21 November and planned for stool samples, IV hydrocortisone (steroids) and antibiotics.
45. On 23 November, Mr D underwent a flexible sigmoidoscopy (a test to check the lower part of the colon for problems like polyps, ulcers, or cancer). Records from 6 December indicate he was responding well to treatment with prednisolone.
46. On 4 and 9 February 2022, the Trust noted Mr D suffered fresh bleed in his stool. The gastroenterology team reviewed him on 9 February.
47. On 18 February, Mr D underwent a further sigmoidoscopy, which revealed severe UC. The gastroenterology team placed him back on IV hydrocortisone.
48. On 3 March, the Trust discussed his presentation at its IBD multidisciplinary team meeting (MDT). In its letter to his GP, the Trust recommended ‘the MDT do feel that he will need escalation [in] his treatment and the recommendation would be ustekinumab (a biological medication that can treat moderate to severe UC), his histology will be reviewed in the next meeting’.
49. The gastroenterology team reviewed Mr D on 9 and 12 May. They noted ‘because of the risk of embolic event with UC, to put [him] back on apixaban.’ On 16 May, a doctor documented a plan to ‘continue apixaban as ongoing flair increase of VTE.’ VTE stands for venous thromboembolism, which refers to blood clots in the veins including DVTs and PEs.
50. Mr D suffered two episodes of black coloured stools and fresh blood in his stool on 25 May. On 26 May, he underwent a gastroscopy. The following day, he was started on fluconazole (an antifungal medication used in this case to treat candidal balanitis, a male yeast infection) 20mg twice daily (BD) for six weeks, then 20mg once daily (OD).
51. Gastroenterology reviewed Mr D on 30 May and advised of an aim for intraperitoneal (administering medication directly into the peritoneal cavity) ustekinumab asap. Ustekinumab was prescribed for the following day and gastroenterology noted they had ‘restarted apixaban as VTE risk is greater than bleed risk’.
52. On 1 June, the gastroenterologist discussed the plan for ustekinumab with Mr D and his daughter, noting it may take six to 12 weeks to have effect. The Trust gave the first dose that day. Mr D was restarted on IV hydrocortisone on 7 June.
53. Our gastroenterologist adviser stated ustekinumab is not recommended as salvage therapy due to its delayed onset of action. It takes over 12 weeks to be effective. Section 1.1 of TA633 recommends ustekinumab as an option for treating moderately to severely active UC when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately, only if a TNF-alpha inhibitor (such as infliximab) has failed, cannot be tolerated, or is unsuitable.
54. Our gastroenterologist adviser explained the reason for using ustekinumab, as opposed to other options, may have been the finding of candidal oesophagitis, but this is easily treated. Their opinion was clinicians would not delay administering infliximab for this reason.
55. On 10 June, a gastroenterologist reviewed Mr D and noted his UC was responding to treatment at that time. They planned to wean his steroids (hydrocortisone) more slowly and continue with nutrition optimisation on 16 June.
56. On 17 June, Mr D suffered bloody diarrhoea and was noted to suffer new confusion. He continued to suffer blood in his stools on 20 June.
57. On 21 June, Mr D was described as having ‘never been in remission’ with regards to his UC. He was transferred to a different hospital under the same Trust for a surgical review regarding his continued PR bleed.
58. During our discussions, our gastroenterologist adviser told us the Trust inadequately treated Mr D’s UC following the first round of steroids in November 2021, which did successfully manage his condition at the time. They stated steroids are useful for initially managing UC, but this would be a temporary solution and is not considered maintenance therapy.
59. The records indicate during his second flare of UC in May and June 2022, the Trust looked to treat Mr D with biologics (ustekinumab). Our gastroenterologist adviser explained it would be suitable as an outpatient drug with a managed condition, but not as an inpatient drug with a patient with acute UC.
60. We asked our gastroenterologist adviser to identify on which occasions the Trust should have prescribed ustekinumab between 11 November 2021 and 1 July 2022. They explained the only time the Trust should have considered ustekinumab was when Mr D went into remission at the end of November 2021. When a patient is in remission, everything looks normal with no inflammation on investigation.
61. At that time, a single course of steroids had put Mr D in remission from his UC, and therefore ustekinumab would be a reasonable maintenance choice. Further, our gastroenterologist adviser identified screening tests were put in place in November 2021 to prepare Mr D for biologics.
62. We consider there was also an opportunity for the Trust to have started ustekinumab on 22 February. At this time, two further courses of steroids had not worked. Regarding infliximab, which is a more appropriate medication in these circumstances, our gastroenterologist adviser identified two opportunities to administer this. Those were in February 2022 and instead of ustekinumab on 1 June 2022.
63. Instead, the records indicate in March 2022, the Trust decided on ustekinumab as treatment for Mr D’s UC. We do not have access to the notes of the meeting where the Trust decided this. We can presume the Trust believed Mr D to be stable and was looking for long term maintenance. However, on review of the records, we consider Mr D’s condition was still acute at the time.
64. Our gastroenterologist adviser explained, in left-sided colitis, the CRP may underestimate the degree of inflammation as the disease is localised. In this case, Mr D was very ill because of the amount of bleeding and diarrhoea he was suffering, as well as his underlying comorbidities.
65. The records indicate, whilst bleeding had settled, Mr D still experienced up to six daily bowel movements in November 2021, May 2022, and June 2022. Our gastroenterologist adviser told us this is still moderately active UC. The flexible sigmoidoscopies taken on 23 November 2021 and 18 February 2022 confirm active UC.
66. Our gastroenterologist adviser agreed with the Trust’s comments Mr D did not meet salvage therapy according to the definition. However, his condition required an affective immunomodulator (substances that modify the immune system to help the body respond to a disease or illness) that would work as quickly as possible to rescue him from a complex and high risk illness.
67. We also need to consider Mr D’s known comorbidity of VTE. Our gastroenterologist adviser told us this made bringing the active colitis under control imperative rather than the need to fulfil the Oxford criteria for salvage therapy. The risk of failing to bring Mr D’s UC under rapid control was far greater than the slightly increased risk of infection, as commented on by the Trust.
68. Infliximab is recommended for salvage therapy due to its rapid onset of action. Patients can feel better within 24 to 48 hours after infliximab is administered. They will not get this with most other immunomodulators and not with ustekinumab. In these circumstances, the Trust should therefore have used therapy that is quick and effective, like salvage therapy, rather than maintenance therapy which can take eight weeks to have effect.
69. In this case, the Trust should have started ustekinumab in either November 2021 or February 2022. It did not start it until 1 June 2022. The Trust also did not start infliximab, which is strongly recommended as salvage treatment by the ECCO guidelines with moderate quality evidence.
70. We consider the Trust should have started infliximab in either February or June 2022. Mr D’s sigmoidoscopy of 18 February shows active UC, and he experienced up to six daily bowel movements in May and June.
71. Overall, we have found failings in the Trust’s management of Mr D’s UC. It failed to follow the relevant national guidelines to administer salvage therapy when it had the opportunity to do so. We consider the impact later in this report.
Treatment to manage the risk of further PE on 20 June 2022
72. Ms D says the Trust did not provide appropriate treatment to manage her father’s risk of further PE, following the diagnosis of the PE on 20 June 2022. Mr D had been on lifelong warfarin, following a PE 20 years prior to this admission.
73. During our correspondence, Ms D told us doctors regularly told her they could not insert an inferior vena cava (IVC) filter to treat her father’s PE whilst he was internally bleeding from his UC. An IVC filter is a small umbrella-shaped metal device placed in the inferior cava (IC) vein to catch and trap larger blood clots. The IC is a large vein that drains blood from the lower half of the body back to the heart.
74. We understand this contradicts the Trust’s complaint response. It explained it did not provide an IVC filter because there is lack of evidence of its effectiveness. It also explained Mr D’s first PE was non-occlusive (it was not caused by the blockage or closing of an open blood vessel or hollow organ), and that it only affected one part of his lung.
75. Ms D feels the inappropriate treatment may have contributed to the development of a further fatal PE, which caused her father’s death on 1 July 2022.
76. We were sorry to hear Ms D’s concerns about her father’s care between 20 June and 1 July, and that she felt this led to his death. It must be incredibly difficult for her. We discussed this matter with our gastroenterologist and respiratory advisers, who both told us NG158 is the most relevant guidance.
77. Section 1.7.2 of NG158 states clinicians ‘should consider an IVC filter with proximal DVT or PE when anticoagulation treatment is contraindicated.’ This is in light of the high risk of repeated VTE and a limited number of alternative treatments available to patients with a contraindication to anticoagulation treatment.
78. Our gastroenterologist adviser also directed us to several other studies and guidelines. Statement 4 of Study B recommends anticoagulant thromboprophylaxis with low dose unfractionated heparin or fondaparinux over no prophylaxis for IBD patients who are hospitalised with moderate-severe flares without severe bleeding.
79. Our gastroenterologist adviser stated all patients with acute colitis should already be taking a low dose of heparin (a blood thinner used to prevent DVTs and PEs), as their risk of forming clots is higher. They said, if a patient has a PE, unless there is torrential or life threatening bleeding, a treatment dose of heparin should be started without delay.
80. Heparin also has a wide range of anti-inflammatory effects. Study C determined that within one week of starting heparin, 12 out of 16 patients had shown a considerable reduction in stool frequency (related to reduced inflammation). By four weeks, 12 out of 16 achieved clinical remission. No serious complications were seen due to the anticoagulant activity.
81. Our review of the records found the Trust prescribed anti-embolic stockings between 7 and 13 June, and then again on 16 and 17 June.
82. On 20 June, Mr D suffered episodes of blood in his stool. The gastroenterology team sent him for an urgent CT abdomen scan, which revealed a non-occlusive PE on the right lung. The records note discussions between the reviewing doctor, interventional radiology (IR) (a medical specialty that performs minimally invasive procedures using medical imagine guidance such as X-rays or CT scans), and gastroenterology consultants.
83. It appears IR was felt to be the best resource to manage ongoing bleeding, and a hospital transfer was arranged for surgery. The Trust withheld apixaban.
84. Following this discussion, staff started Mr D on tranexamic acid (a medication used to treat or prevent excessive blood loss) on 20 June, which was discontinued eight days later. Our gastroenterologist adviser told us tranexamic acid stops blood clots from breaking down.
85. Regarding tranexamic acid, NIHCR guidelines state ‘tranexamic acid does not reduce deaths from gastrointestinal bleeding but increases the risk of thromboembolic events (clots in the veins of the legs that can move to the lungs).’ NIHCR guidelines found no difference between the groups studied in the risk of a bleed occurring again a short while later.
86. BNF guidelines list ‘thromboembolic disease’ under contraindications for tranexamic acid. The drug information sheet for tranexamic acid states it is an antifibrinolytic (a type of drug used to prevent or treat heavy bleeding). It may increase the risk of thromboembolic events. It also lists thromboembolic disease as a contraindication.
87. The electronic prescribing record indicates tranexamic acid 1g three times daily was administered from 20 June until the afternoon of 28 June. Our respiratory adviser calculated that, in total, Mr D received 19 doses of 1g IV tranexamic acid. Two doses were missed and two were withheld.
88. Mr D suffered further PR bleeds overnight on 21 June. A medical registrar (a doctor training to be a specialist) ordered a CT triple phase abdomen (a plain CT, arterial phase, and portovenous phase), which showed no obvious acute bleed within the gastrointestinal tract. A flexi sigmoidoscopy performed the same day showed extensive severe oedema in the colon, as well as showing two ulcers covered with two clots.
89. A doctor informed Ms D on 21 June it was not safe to restart an anticoagulant as her father could have a fatal bleed. They advised this would be assessed on a day to day basis and they would restart when Mr D’s bleeding was controlled. Ward round notes show anticoagulants were withheld on 22 June and there was a plan to discuss an IVC filter.
90. Our respiratory adviser stated Mr D’s active bleeding was sufficiently severe to cause him to become acutely anaemic. In this circumstance, their view was that the only possible method of protecting him from further events was a mechanical filter (such an IVC filter).
91. Our gastroenterologist adviser disagreed. They explained, whilst patients with UC can suffer bleeding and become anaemic, it is very unlikely that this will reach haemorrhage-level bleeding. They stated anaemia in acute severe UC patients can be treated with blood transfusions.
92. The records show Mr D had some bleeding (six episodes over five days). We could not see that this was documented as being at a significant level as to indicate the Trust should not have given a treatment dose of heparin.
93. The Trust’s response says it did not insert an IVC filter as there was little, if any, evidence of likely benefit. Our respiratory adviser explained other clinicians would have undertaken inserting an IVC filter, given the lack of anything else that would protect Mr D from further embolic events. This would be a clinical judgement, however, there is no evidence of multidisciplinary consultations (i.e. with haematology) in the records.
94. During this time, the gastroenterology team noted Mr D was clinically well, but his UC was noted to be extensive, and he had ‘never been in remission.’ They planned to continue IV hydrocortisone and to ‘continue to withhold anticoagulation on balance of bleeding risk, however if clinical signs of PE/DVT, needs discussion with haematology’.
95. The Trust stopped the oral anticoagulant and decided not to use heparin prophylaxis due to fears of exacerbating bleeding. The medication administration history records document 40mg of enoxaparin sodium (low molecular weight heparin) was given on 13, 14, and 15 June, and a dose of 95mg was given twice on 18 and 19 June, withheld on 20 June, and given once on 30 June.
96. Both of our advisers agreed it was reasonable for the Trust to stop apixaban on 20 June. Our gastroenterologist adviser stated the anti-embolic stockings were insufficient against preventing a DVT/PE. If available, an intermittent pneumatic compression device should have been used. However, they said neither measure would be adequate to prevent a recurrent PE safely.
97. Our gastroenterologist adviser stated heparin prophylaxis needed to be restarted at the earliest opportunity, which they identified as 20 June. At this point, we identified heparin was withheld and was not restarted until 30 June. Our gastroenterologist adviser explained a low molecular weight heparin is the most effective at preventing clots. As stated in the above studies and guidelines, treatment doses of heparin are considered safe in acute UC as they may reduce inflammation. Therefore, also reducing the bleeding risk.
98. We acknowledge our two advisers do not entirely agree regarding their recommendations for an IVC filter compared to heparin prophylaxis. On review of the records, we could not see any evidence Mr D’s bleeding was severe enough to rule out giving heparin prophylaxis. Specifically, we only found reference to ‘bloody diarrhoea’ and ‘episodes’ of blood in the stool on 17, 20, and 21 June.
99. We therefore find the Trust failed to provide Mr D with a treatment dose of heparin. This is contrary to Study B and C.
100. Our gastroenterologist adviser told us it is important to distinguish that heparin is not being used to ‘treat’ Mr D’s UC. Study D determined that unfractionated heparin as monotherapy is not effective in the treatment of moderate or severe colitis and is associated with significant bleeding complications.
101. However, our gastroenterologist adviser stated having UC is not sufficient reason to not give heparin for a patient like Mr D, who has a history of PEs and is on lifelong warfarin. He was a high risk patient. Clinicians would want to avoid clotting and a PE in a patient like this.
102. Instead of heparin, the Trust gave Mr D tranexamic acid between 20 and 28 June. The records show Mr D had a history of clots and suffered a recent clot. The Trust failed to follow NIHCR guidelines in giving tranexamic acid. NIHCR guidelines found venous thromboembolic events were higher in the group receiving tranexamic acid. It recommended it should not be used for the treatment of gastrointestinal bleeding. This is a failing by the Trust.
Impact of poor management of bowel disease and of the risk of a further PE
103. Ms D told us she felt her father suffered unnecessarily and declined in physical function as a result of inactivity because of the poor management of his bowel disease. It must have been difficult for Ms D to witness her father suffering.
104. Ms D also told us she felt the inappropriate treatment from 20 June 2022 onwards may have contributed to the development of a further PE, which caused her father’s death on 1 July 2022.
105. In its complaint responses, the Trust advised it would not have given anticoagulation sooner and there were no concerns of a large PE at the time. It explained it was reasonable to withhold anticoagulation on specialist advice until after a period of observation and monitoring blood count. It explained, given the events, it is unlikely that starting treatment one or two days sooner would have made any difference to the outcome.
106. Based on its complaint responses, we consider the Trust has not yet acknowledged any failings in its treatment of Mr D’s bowel disease, nor its treatment of him between 20 June and 1 July 2022.
107. To address what the clinical impact may be, we sought further advice from our gastroenterologist adviser and provided them with a copy of Mr D’s death certificate.
108. We asked our gastroenterologist adviser if they could be specific about what the clinical impact would be. Specifically, we asked whether salvage therapy with infliximab would have prevented the death of Mr D.
109. Our gastroenterologist adviser directed us to Study E as the relevant guideline, which highlights that overall colectomy-free survival with infliximab as salvage therapy was 79.7% at three months and 69.8% at 12 months.
110. Our gastroenterologist adviser also directed us to Study F. We have not relied on this as a clinical guideline because it post-dates the events complained about. However, Study F determined infliximab is still highly used as a salvage therapy for UC as of 2023. It also determined ustekinumab is an ideal candidate for use as a maintenance therapy.
111. In this case, we consider there were two missed opportunities in February and June 2022 for Mr D to have infliximab as treatment and to respond to it. We also consider there was a missed opportunity to have ustekinumab after the Trust weaned him off prednisolone during his first UC flare up in November 2021. We have considered the Trust’s comments on this, but those have not changed our findings.
112. Our gastroenterologist adviser told us the Trust decided on 20 June 2022 not to treat Mr D’s PE (with heparin) and instead to give him tranexamic acid. They explained the impact of this is a very significant increase in the likelihood he would suffer a further PE.
113. To support this, our gastroenterologist adviser directed us to the HALT-IT guidelines. Based on a study of 12,009 patients between 4 July 2013 and 21 June 2019, the HALT-IT guidelines found death due to bleeding within five days occurred in 4% of patients given tranexamic acid and in 4% of patients given a placebo.
114. Venous thromboembolic events (deep vein thrombosis or PE) were higher in tranexamic acid group than in the placebo group, at 0.8% and 0.4%, respectively. Ultimately, the HALT-IT guidelines determined ‘tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.’
115. On 1 July 2022, Mr D suffered a further PE. His death certificate, provided by his daughter, lists his cause of death as ‘pulmonary embolism due to or as a consequence of deep vein thrombosis.’
116. Our gastroenterologist adviser stated had the Trust given heparin prophylaxis from 20 June, it is more likely than not Mr D would have avoided a further PE. To support this, they directed us to Study B. This says IBD patients have about a three-fold higher risk of VTE compared with the general population, with the absolute risk being much higher in the hospital setting compared with the nonhospital setting.
117. Statement two in Study B says moderate-severe disease activity is an important factor that drives the risk of VTE in IBD and should be considered a provoking factor. Lastly, statement three says the risk of VTE during a hospitalised IBD flare is estimated to be six-fold higher than during a nonhospitalised flare.
118. There is medical literature included in the evidence for NICE NG89 on the effectiveness of medication such as heparin in preventing VTE or PE. Our gastroenterologist adviser explained, even if there is a 12 hour delay in starting heparin prophylaxis following a PE, the risk of a further PE may increase by an estimated 18-fold. They said it is more likely than not, had the Trust given Mr D heparin, it would have avoided a further PE.
119. Our gastroenterologist adviser also considered it is unlikely Mr D would have suffered a major gastrointestinal bleed on heparin, which appeared to be the Trust’s main concern. Even if he did suffer a significant bleed, the risks-benefit strongly favoured giving heparin.
120. Based on this, the Trust should have given a treatment dose of heparin from 20 June 2022 onwards and should not have given tranexamic acid. We consider these actions significantly increased the risk of Mr D suffering the further PE on 1 July 2022, as documented by Study B, which led to his death. Therefore, on the balance of probabilities, Mr D suffered a potentially avoidable death. This is our most serious finding.
121. In her correspondence with us, Ms D has told us she is grieving and has been since her father died. She told us the treatment of her father has caused her unnecessary distress and trauma. In her complaint form, Ms D documented she felt there was a slim chance her father’s death could have been avoided or could have been a ‘better’ death for him. Ms D described her father as ‘much loved’.
122. We understand that our work cannot bring Ms D’s father back to her and that we can only reiterate our condolences for her loss and for any suffering her father experienced in his last months. This is a very emotive case for us to consider. We have made recommendations to address this injustice at the end of this report.
Treatment on 1 July 2022
123. Ms D complains the lack of appropriate treatment on 1 July reduced her father’s chance of survival. She says it also did not allow him to have a comfortable and dignified death. Ms D says she feels the interventions provided on 1 July may not have been suitable for someone suffering a PE.
124. When relaying the events of 1 July, Ms D told us her father’s doctors advised he had become very unwell and was unresponsive with low blood pressure. When she saw her father, she told us he was unresponsive and gasping for breath.
125. Ms D told us the doctors were unable to complete a CT brain scan to rule out a brain bleed, and the intensive care unit (ICU) team intubated her father. Ms D told us her father’s team later stated her father went into cardiac arrest during resuscitation. The ICU team explained he was to stay on oxygen until his heart stopped.
126. We were sorry to hear Ms D felt her father was not given the opportunity for a comfortable and dignified death. We understand the events of this day in particular were distressing. It is difficult to grieve the loss of a parent in any circumstances, but it must have been especially hard when her father had not been discharged home for a long time. To address her concerns, we discussed the care and treatment provided on 1 July with our respiratory adviser.
127. We consider NICE NG31 to be most relevant for this part of the complaint. NG31 says it is often difficult to be certain that a person is dying. This is because the ways in which people die and how long this takes varies widely. The guidelines are intended to add to individual clinical judgement on prognosis, but not to override it.
128. Our respiratory adviser stated the evidence shows Mr D’s deterioration was severe, abrupt, and unexpected. Appropriate actions were undertaken but were unsuccessful. Given the acute, unexpected nature of all of this, our respiratory adviser told us it would not have been possible to have a more palliative plan in place.
129. At 1.30am on 1 July, a doctor reviewed Mr D due to tachycardia (fast heart rate). He was noted to be uncomfortable. IV fluid was prescribed.
130. Mr D suffered a hypoglycaemic (low blood sugar) episode at 7am. A nursing entry from 7.30am documented Mr D was not alert and not responding to voice. Nursing staff took observations and escalated to medical staff.
131. At 8.45am, a doctor reviewed Mr D due to clinical deterioration. They noted Mr D still had a fast heart rate. They noted his blood pressure was low and that his blood oxygen saturations were difficult to record. Our respiratory adviser explained this is likely due to poorly palpable peripheral pulses (the rhythmic expansion and contraction of arteries away from the heart), likely secondary to the low blood pressure.
132. They also noted Mr D was markedly tachypnoeic (breathing fast). Our respiratory adviser noted the doctor requested an ICU review, which was appropriate.
133. At 9.40am, the records note a discussion with the ICU team and a plan to request a CT head scan that day. The records note Mr D had suffered acute deterioration in his consciousness level, which is also reflected in the nursing entries.
134. At 10.20am, the records note Ms D had been informed her father had a cardiopulmonary arrest and the ICU team had attempted to resuscitate him. It appears a possible intracerebral cause for his deterioration was queried at the time.
135. At 10.45am, a retrospective entry by a member of the ITU team noted Mr D did not respond to initial resuscitation attempts, including interventions to improve his blood pressure and heart rate. Staff performed an emergency intubation, but his condition did not improve.
136. A combined decision was made to stop further resuscitation due to Mr D being deconditioned (having lost physical strength through being ill and inactive) for some time and was currently adrenaline-dependant (reliant on synthetic adrenaline). At 1.10pm, a doctor verified Mr D’s death.
137. In summary, Mr D deteriorated quickly. Nursing staff requested medical intervention quickly, and his care was escalated to the ICU team. The Trust continued to actively treat Mr D during this time to avoid his death. Unfortunately, this meant there was limited opportunity to put a more palliative plan in place.
138. Having considered the evidence, there is no failing in this part of Ms D’s complaint. The Trust acted in line with national guidelines in treating Mr D on 1 July 2022 as staff continued to perform medical interventions. His deterioration was unexpected and sudden at that time. His death certificate lists a pulmonary embolism as the cause of death.