Communication about the risks of DVT and symptoms
20. Mrs F complains clinicians did not give her brother enough information about the risks of surgery and the risks of developing a blood clot. She questions if clinicians gave him enough time before surgery to fully consider the risks. She complains they did not tell him about the symptoms of DVT to be aware of after surgery.
21. The Trust told us Mr G was an acute admission. This means he did not have a pre-assessment clinic appointment to discuss the procedure because he was operated on the same day that he went in. It said the orthopaedic team explained the risks of surgery and he signed a consent form. The risks of the procedure included DVT and PE.
22. GMC guidance for consent says ‘all patients have the right (…) to be given the information they need to make a decision and the time and support they need to understand it’. It also says that in emergency situations, ‘decisions may have to be made quickly so there’ll be less time to apply this guidance in detail, but the principles remain the same’.
23. Our orthopaedic adviser says Mr G’s injury meant he needed surgery as soon as possible. The Trust was able to schedule this for him without delay. In reviewing the consent form Mr G signed, this lists the risks of the procedure including DVT and PE. Our orthopaedic surgeon adviser confirmed the consent form includes the relevant risks to discuss with a patient for this surgery.
24. GMC guidance for consent says decisions may have to be made quickly in emergency cases, but the person still must be able to give their informed consent for treatment. From the evidence we have seen, we have not seen reason to question Mr G’s understanding of the risks or his ability to consent to the procedure. We are satisfied doctors told Mr G about the risk of developing DVT.
25. Mrs F says if her brother had been fully informed of the signs of DVT, he would have seen a doctor without delay when he was struggling with pain and was unable to walk. She said clinicians did not give him anything in writing to refer to or to share with his family.
26. GMC guidance says doctors ‘must give patients the information they want or need to know in a way they can understand.’
27. NICE guidance NG89 says that on discharge, clinicians should give people who are at an increased risk of blood clots written and verbal information on ‘the signs and symptoms of deep vein thrombosis (DVT) and pulmonary embolism’. They should be told about how they can reduce the risk of this, and of the importance of getting help if DVT or PE are suspected.
28. The Trust said clinicians gave Mr G written and verbal discharge instructions. It said patients are told to go to the ED if they develop a sudden cough or shortness of breath. The Trust gave us a copy of the written information it gives to patients which covers care of the cast and information about DVT. It says it asks patients to sign a slip confirming they have been given a copy of this information, but in 2019 to 2020, it destroyed slips that were over a year old, so it cannot give us evidence of Mr G getting a copy. It now keeps this information electronically.
29. The Trust also said it gives patients information about DVT in the plaster room after they have been given a cast. Mr G’s plaster was put on in the operating theatre so this did not apply to him.
30. The discharge checklist in Mr G’s records says, ‘written and verbal instructions given and agreed’. The notes say he had crutches and that he was given a demonstration of how to take the prescribed 40mg Clexane dose.
31. Our orthopaedic adviser says it was likely Mr G was told the reason and importance of the Clexane injections when given this demonstration, but this is not noted in the medical records. There is no record of what clinical staff told Mr G to look out for during his recovery from surgery.
32. We do not dispute what the Trust has told us about giving Mr G written information and can see the discharge checklist says he was given this. But we also accept Mrs F’s comment that her brother did not have anything written to refer to. She says this would have been helpful to him and to the family.
33. We have not ignored what the Trust or Mrs F told us and we have carefully considered if we can reach a decision on if Mr G was told how to recognise the symptoms of DVT after surgery.
34. While the records do not include details of what clinicians told or gave to Mr G, they support that they gave him instructions about his recovery. The information the Trust has since shared with us also does not directly prove that Mr G got the information leaflet, but overall we think it supports that it regularly gave (and gives) this to patients and it has a system to monitor this. We think the reason why it cannot prove it gave Mr G this information (because it used to destroy paper slips after a year) is reasonable.
35. We are aware Mrs F was not with her brother when he was discharged from the hospital to hear what clinicians told him. We also do not think it is the Trust’s fault if clinicians gave Mr G written information, but Mrs F did not see this.
36. We find the records and information from the Trust to be persuasive. We have decided it is more likely than not that the Trust gave verbal and written information to Mr G about the symptoms he should be aware of during his recovery. This meets the standards explained in the GMC and NICE guidance.
37. We are sorry to hear Mrs F’s concerns about the information the Trust gave her brother. We hope we have been able to clearly explain how we have reached our decision from the evidence we have seen.
Care provided in the ED on 11 June
38. Mrs F told us that after her brother had surgery, he struggled to walk and his leg was very painful. She complains that when he went to the ED on 11 June, doctors did not do enough to investigate his symptoms. She is concerned a doctor said they needed to ‘rule out DVT’, but this was not done.
39. The records from the ambulance crew who took Mr G to hospital say he had experienced increasing pain over the last two days. On arrival, an orthopaedic doctor assessed Mr G. They documented his pain and queried if DVT may be the cause. The doctor requested an X-ray, blood tests and a senior review.
40. A senior orthopaedic doctor reviewed Mr G at 4.50pm. They noted Mr G had pain from his knee down to his right ankle and this was a common complaint for someone who had just had surgery on their patella tendon. They looked at the wound and saw this was not oozing and his calf was soft and not tender. Mr G had normal observations and no breathing difficulties. The doctor did not think he was showing any signs of DVT, and after clinicians changed his cast, the doctor sent him home.
41. Our orthopaedic adviser explained the signs of DVT are leg swelling, localised pain (pain in one area), skin changes such as warmth, redness, fluid retention and vein swelling. These signs alone cannot be used to diagnose someone with DVT, but they should alert doctors to consider DVT and do the relevant tests as needed.
42. NICE guidance CG144’ says when a person has signs of DVT, doctors should consider the person’s medical history and do a physical examination to rule out other causes. If doctors suspect DVT, they should refer to the ‘DVT Wells score’. The Wells score is a tool used to predict the chance of a person having DVT.
43. Our orthopaedic adviser said Mr G was at a high risk of developing DVT. This is because he had recently had surgery on his lower limb. The clinical study, ‘natural history of venous thromboembolism [blood clots]’ says that 75% of DVT after orthopaedic surgery happens in the operated leg. The risk of DVT ‘is highest within 2 weeks of surgery’. Mr G went to the ED less than two weeks after surgery.
44. Another risk factor was Mr G’s reduced mobility due to his leg being in a plaster cast. This increases the risk of DVT because if the muscles in the legs are inactive, blood is not circulating back up the body as it normally would. This increases the risk of a clot forming in the legs.
45. Mr G had pain, a possible symptom of DVT, and his clinical history showed he was at high risk of developing DVT. Because of these factors we think the clinical team should have suspected Mr G had DVT. Although the clinical team considered this at first, they ruled it out without considering NICE guidance CG144.
46. The Wells score tool lists clinical features and gives points to each. The overall score then tells the clinician if a person may have DVT or not. In Mr G’s case, ‘recent plaster immobilisation of the lower extremities’ scores one point. ‘Recently bedridden for 3 days or more, or major surgery within 12 weeks requiring general or regional anaesthesia’ also scores one point.
47. Mrs F told us her brother slept on their father’s couch and was immobile after the procedure. Bedridden means someone who cannot leave their bed. When Mr G went to the ED, doctors noted he was able to partly bear weight on his left leg. A nurse noted that after his plaster cast had been changed, he was ‘slow and steady’ and dragging his leg.
48. From what Mrs F has told us and from the evidence in the records, it is clear Mr G’s mobility had been affected a lot after his surgery. He had a lot of pain and we do not doubt that this made it difficult for him to move around. But the descriptions of him being able to move to a degree in the ED suggest he would not be classed as bedridden.
49. Mr G meets the criteria of having recent plaster immobilisation of the lower extremities which means he scored at least one point on the Wells score tool. Our orthopaedic adviser, noting that the Trust felt Mr F did not have clinical signs of DVT but also that a clinical diagnosis of DVT is quite unreliable, says Mr G had a Wells score between one and two.
50. NICE guidance CG144 says that a Wells score of one point or less means ‘DVT [is] unlikely’. Doctors should offer patients a D-dimer test. A D-dimer test looks for the protein fragment called D-dimer in the blood. Higher levels of this can suggest blood clotting.
51. If the D-dimer test is positive (the levels are high), the guidance says doctors should ‘offer a proximal leg vein ultrasound scan, with the result available within 4 hours if possible’. Or doctors should start the person on a treatment dose of anticoagulant medication with the scan result being available within 24 hours. A proximal leg vein ultrasound scan looks at the flow of blood in the veins from the groin to the knee.
52. NICE guidance CG144 says a Wells score of two points or more means DVT is ‘likely’. If doctors had decided Mr G met this, the guidance says the person should be offered ‘a proximal leg vein ultrasound scan carried out within 4 hours of being requested’. If they are unable to meet this timescale, the person should have a D-dimer test, be given anticoagulant treatment and the scan result should be available within 24 hours.
53. In line with NICE guidance CG144, we consider Mr G’s symptoms and risk factors should have made clinicians suspect DVT and do the relevant tests. As a minimum, they should have done a D-dimer test.
54. The clinical studies ‘variation of plasma D-dimer following surgery’ and the ‘kinetics of D-dimer after general surgery’ say D-dimer levels can increase and change after surgery. Along with other factors, the type of surgery and length of surgery all play a role in how much the D-dimer levels are affected.
55. If Mr G had a D-dimer test on 11 June, our orthopaedic adviser says that due to his recent surgery, it is highly likely that his levels would have been raised. This is because the body’s clotting system would have been active as his wound was still healing. It may also have been raised because he had DVT.
56. Based on what we have seen, we think it is more likely than not that Mr G’s D-dimer test result would have been positive on 11 June, either because of his recent surgery, or DVT, or both. This means in line with NICE guidance CG144, clinicians should have arranged for Mr G to have an ultrasound scan to check for blood clots in his veins.
57. The Trust said it did not do an ultrasound scan because clinicians did not consider this was needed. They decided his pain was likely due to recent surgery, and his blood tests were not of concern. Mrs F has questioned what the blood tests showed as she thinks some of the raised levels could have also suggested DVT.
58. We think Mr G’s pain was a sign of possible DVT. Our haematology adviser said the results of Mr G’s blood tests that day show changes in the blood that suggest inflammation (swelling) and that mechanisms in the body that cause blood to clot were active.
59. Our haematology adviser said the blood test results would not be surprising for someone recovering from recent surgery. We would not have expected the Trust to suspect DVT based on the blood tests alone, but we do think that in combination with Mr G’s clinical history and symptoms, doctors should have had suspected DVT.
60. If doctors thought Mr G had a Wells score of two, the first step would have been to do an ultrasound scan. Whether Mr G had a Wells score of one or two, in line with the NICE guidance CG144 and the chances that Mr G had abnormal D-dimer levels, we think doctors should have done an ultrasound scan on 11 June. We have decided the lack of tests to check if Mr G had DVT is a failing.
61. Mrs F told us she believes that if her brother had been correctly diagnosed and cared for, he could have been given life-saving treatment.
62. We asked our haematology adviser what an ultrasound scan would have shown if this had been done on 11 June. They said clinical studies say that most blood clots form in the first two weeks after surgery, and with Mr G’s clinical history, it is more likely than not that DVT was present in his left leg on 11 June.
63. We reviewed the National Clinical Guideline Centre’s guideline, ‘Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing’ to look at if an ultrasound scan would have shown DVT. This includes a summary of a study of the sensitivity of ultrasound scans. It says the success rate of ultrasound scans in detecting DVT in the proximal veins is 94%.
64. We think that if clinicians had arranged an ultrasound scan for Mr G on 11 June, it would probably have shown he had DVT. In this case, in line with NICE guidance CG144, clinicians would have offered Mr G anticoagulant treatment (or continued this should they have already started to give this).
65. Mr G was prescribed a preventative dose of the anticoagulant Clexane after his surgery. Our haematology adviser explained a treatment dose is a much higher dose of the anticoagulant. At this higher level, the anticoagulant treats DVT by stopping the clot from growing any bigger and from being able to move up the body. It also stops any new clots from forming.
66. We have considered the difference it would have made to Mr G’s outcome if he had been given a treatment dose of an anticoagulant from 11 June. Our haematology adviser said this treatment is usually very successful. A clinical study says, ‘most patients’ will respond to anticoagulation, ‘which is the foundation of treatment’.
67. A study says that within the first three months of a person being given anticoagulant treatment, their risk of a repeated fatal blood clot was 0.4%.
68. On review of these clinical studies and the clinical advice we have had, we think if Mr G had been given anticoagulant treatment from 11 June, it is highly likely he would not have had a fatal PE.
69. To summarise, we think Mr G likely had DVT on 11 June and doctors should have done a D-dimer test. The result of this would likely have been positive which should have meant Mr G needed an ultrasound scan. We consider this scan would have found a blood clot and had this been treated, it is likely the treatment would have been successful. This means we think it likely that Mr G would not have died when he did. Sadly, we think Mr G’s death was avoidable.
70. The effect of the loss of her brother on Mrs F has been devastating. She believes that if he had been treated correctly, he would not have died at such a young age, and we agree with her. We recognise this impact will be ongoing for Mrs F who sadly will have to live with knowing this.
71. The Trust did not find that anything went wrong in the care it provided to Mr G. We have made recommendations to put right the impact Mrs F has experienced.
Care provided at the outpatient appointment on 25 June
72. Mrs F complains her brother went to hospital on 25 June for a review appointment and, despite his leg being red and swollen, clinicians took no action to investigate if he had DVT. She says they missed another opportunity to diagnose and treat him.
73. The Trust said an orthopaedic doctor reviewed Mr G and the team changed his cast. The surgeon was happy with the X-ray from 11 June and did not see any signs of infection in the wound. The Trust said Mr G did not have symptoms that would have alerted the doctor to the possibility of DVT.
74. GMC guidance says doctors who assess, diagnose or treat patients must ‘adequately assess the patient’s conditions, taking account of their history’ and ‘where necessary, examine the patient’. They must also ‘promptly provide or arrange suitable advice, investigations or treatment where necessary’.
75. The records do not include any mention of the surgeon physically examining Mr G or of him having any symptoms on this date. Our haematology adviser said that if Mr G’s skin had been red, the bandages around his cast may have hidden this. But, if DVT is causing redness, this is usually also accompanied by marked swelling. If Mr G’s leg had been very swollen on that date, it would have been difficult for the team to miss because it would have caused problems with the plaster cast.
76. Our haematology adviser explained that 80% of patients presenting with a PE do not have signs of DVT, so it would not be surprising if Mr G did not have signs of DVT at that time.
77. Our orthopaedic adviser said the overall examination recorded by the surgeon on 25 June is satisfactory and meets the GMC guidance. Although there is no record of the physical appearance of Mr G’s leg, there is also no reference to Mr G complaining of any symptoms.
78. We think that if Mr G had signs of DVT on 25 June, they would have been difficult to miss during the plaster change. If his leg was swollen, this would have caused the plaster to become tight.
79. We do not ignore what Mrs F told us and understand she saw her brother continue to struggle with his recovery in the weeks after his surgery.
80. After careful consideration of the information, overall we do not think we can say the surgeon missed the opportunity to identify that Mr G had DVT on 25 June. We understand the events on this date have been another source of distress for Mrs F. We hope we have been able to fully explain how we have reached our decision.