Use of Dalteparin and Carvedilol
20. Ms A says Dalteparin should not have been given to Mrs A as she had active bleeding. She feels the use of this medication may have contributed to Mrs A’s death.
21. Our adviser told us that patients with chronic liver disease are known to be at a higher risk of venous thromboembolism (VTE- an umbrella term for deep vein thrombosis and pulmonary embolism, both involving blood clots), as are people with reduced mobility due to acute illness. Treatment using low molecular weight heparin (a type of anticoagulant medication that prevents and treats blood cots), such as Dalteparin is routinely used for patients at high risk of VTE and this is standard practice as long as platelet count is over 50-75 (which it was).
22. The medical records show that a reduced prophylactic (preventative of disease) dose of Dalteparin was started once the initial bleeding episode had been adequately treated. Platelet count did not drop below 50 throughout the period up until her deterioration on 29 December. There is no evidence of significant bleeding in the medical records, during the regular observations or in blood tests. There was no significant drop in haemoglobin until 29 December and it was relatively stable until that point.
23. Caution or dose reduction is advised by the British National Formulary guidance on Dalteparin because there is a recognised increased risk of bleeding, especially where there is severe liver impairment. The Trust followed this advice and prescribed half of the usual prophylactic dose after Mrs A’s surgery to clip the burst stomach ulcer.
24. Our adviser highlighted that bleeding events are rarely encountered in clinical practice in those using prophylactic doses and there was a clear indication in Mrs A’s case to use the drug. It is possible that the small dose of Dalteparin may have made some contribution to the bleed that occurred, as noted in the Trust’s complaint responses dated 7 August 2023 and 19 March 2024.
25. Ms A says Carvedilol has many side effects and should not have been given to Mrs A as she had liver disease and respiratory issues. She feels the use of this medication may have contributed to Mrs A's death.
26. Carvedilol is a beta blocker drug, used to manage high blood pressure as well as other cardiac conditions. It is also a well-recognised treatment for patients with chronic liver disease with evidence of portal hypertension (elevated pressure in the vein that carries blood from the digestive organs to the liver) as it is known to reduce the portal pressure and hence reduce the risk of bleeding from enlarged veins in the oesophagus. It is used both as primary prophylaxis (where there has not been a history of bleeding, but there is a known significant portal hypertension) and as secondary prophylaxis (where there has been a variceal bleed already).
27. The medical records state a CT scan showed Mrs A had significant portal hypertension so the Trust decided to switch from the beta blocker Mrs A was already on (Bisoprolol) to Carvedilol. Carvedilol is one of the recommended options in British Society of Gastroenterology Guidelines: UK guidelines on the management of variceal haemorrhage in cirrhotic patients.
28. Clinicians would be expected to monitor patients on Carvedilol for adverse events such as, low blood pressure, low heart rate, asthma and fatigue. Mrs A was on Carvedilol from 19 to 22 December. During this time, there was no significant change in her blood pressure or heart rate recordings which both remained within satisfactory ranges. The records on 22 December note Mrs A felt short of breath and wheeze was heard on the chest examination, and therefore Carvedilol was stopped. There were no signs of respiratory distress (a condition where the body needs more oxygen, it can cause rapid breathing, difficulty breathing and low oxygen levels in the blood) while Mrs A was on Carvedilol, her respiratory rate and oxygen saturations remained stable throughout.
29. We consider the Trust’s decisions to treat Mrs A with Dalteparin and Carvedilol were appropriate and in line with standard clinical practice.
30. Whilst Dalteparin could have had a small contribution to the bleed, we consider that overall, the use of Dalteparin was appropriate to manage Mrs A’s high risk of DVT. The Trust appropriately mitigated the risks of bleeding by giving Mrs A a reduced dose in line with guidance. The records show she was monitored regularly and there was no evidence of significant bleeding whilst she was taking this medication. We consider the Trust used Dalteparin correctly as her platelets were above 50-75 throughout the period it was used.
31. We consider the use of Carvedilol was appropriate as Mrs A had significant portal hypertension, which this drug is routinely used to treat. During the few days she was taking the medication, she was regularly monitored and there was no significant change to her observations. Our adviser confirmed that Carvedilol would not have contributed to Mrs A’s bleed or risk of bleeding nor did it affect her breathing. The evidence we have seen shows Carvedilol was given to Mrs A in line with guidance and therefore we do not consider there were failings on the part of the Trust.
Timeliness of interventions for respiratory and kidney issues
32. As detailed above, Ms A feels Mrs A’s respiratory issues may have stemmed from the use of Carvedilol. She also told us Mrs A did not have kidney issues when she went to hospital on 13 December 2022. She says it was only after she went back to ICU after 29 December that her kidneys began to fail and she was then put on dialysis. Ms A says the Trust found that Mrs A had intra-abdominal bleeding on 28 December but by 29 December, her kidneys were severely injured. She wonders whether Mrs A may not have developed abdominal bleeding had the ascites been treated sooner by draining the fluid. She says Mrs A was fragile and the fluid might have caused the bleeding to happen. She feels the Trust did not treat or manage Mrs A’s respiratory and kidney issues in a timely manner.
33. The medical records and multi-disciplinary team discussion with Kings College Hospital’s Liver team tell us that Mrs A has a history of decompensated liver disease, i.e. liver disease of sufficient severity that transplantation had previously been considered. She then had a significant bleed from a stomach ulcer which led to her admission at the Trust in December 2022.
34. Our adviser told us that the immediate clinical issues as well as the stress of other illness can often lead to deterioration of liver function in people with cirrhosis (a progressive liver disease). This is what happened in Mrs A’s situation, the result was fluid overload. The Trust appropriately started additional diuretics (she was already on some diuretics before admission to the Trust) to help control this. This is in line with standard practice. Our adviser explained drainage procedures are reserved for situations where diuretic tablets are inadequate (which does not appear to have been the case for Mrs A).
35. Mrs A complained of shortness of breath and was noted to have a wheeze on 22 December which meant interruption of the Carvedilol. Although she had felt breathless, there is no evidence of respiratory distress until 29 December, when she became seriously unwell due to the major intra-abdominal bleed.
36. There is no evidence in the medical records of renal (kidney) impairment until 29 December. On 27 December, creatinine (blood marker of renal function) was stable at 71. On 29 December it had risen to 149, at the same time as Mrs A became extremely unwell. There are no signs of renal problems in the admission before this. Even though liver disease can cause kidney problems, both a major bleed and blood infection put significant stress on kidney function as there would be less circulating blood to supply the kidneys due to the drop in blood volume and blood pressure. Fluids, blood products and other treatments (diuretics) were given to try to improve renal function.
37. We consider that Mrs A was under respiratory distress and had kidney problems from 29 December onwards. We consider the Trust provided Mrs A with adequate treatments from this date onwards, including with diuretics to remove the fluid and blood products, when it was clinically indicated (i.e. when her creatinine increased to 149 on 29 December). It was not possible to provide treatment for the kidney and respiratory issues before this date as there was no sign these issues were present before this point. On that basis we have not seen failings in the care provided by the Trust in relation to Mrs A’s respiratory and kidney issues.
38. We recognise the ongoing impact and distress that the events have had on Ms A. We hope that our report has provided some clarification on why we consider the medications used to treat Mrs A were appropriate and in line with guidance, given her symptoms and history and that the Trust managed her respiratory and kidney issues in a timely manner.