United Lincolnshire Teaching Hospitals NHS Trust

4. Mrs C complains on 10 February 2024, the Trust did not act in line with guidance in response to her mother, Mrs O’s raised D-dimer levels, by taking a CT scan and admitting her to hospital for treatment. Mrs C complains the Trust inappropriately administered enoxaparin by injection, without first conducting a scan to confirm the presence of a clot.

5. Mrs C considers the injected enoxaparin caused a bleed on her mother’s brain, that very sadly led to her death from intracranial haemorrhage. Mrs C says if not for the above failings, her mother may have received different treatment and lived.

6. To resolve her complaint, Mrs C would like the Trust to acknowledge these failings, apologise for their impact, and provide a financial remedy.

7. Mrs O attended the Trust’s emergency department (ED) on the evening of 10 February 2024, presenting with palpitations and shortness of breath. She was examined by a doctor, blood tests were taken a chest X-ray was performed.

8. Blood results returned and her D-dimer level was high. The D-dimer test checks for blood clotting problems, by measuring the amount of D-dimer, a protein the body makes when blood clots break down.

9. The doctor suspected a pulmonary embolism (a blood clot in the lungs) and Mrs O was given an injection of enoxaparin (an anticoagulant, or blood thinning medication). She was discharged home in the early hours of 11 February, with a plan for an outpatient CT scan.

10. Soon after lunchtime on 11 February, Mrs O’s husband saw that she was unable to talk, with a right sided weakness and facial droop, and he suspected she had a stroke. Mrs O returned to the Trust where she was admitted, and a large bleed on the brain was confirmed.

11. Mrs O’s condition did not improve, and she very sadly died at the Trust on 18 February.

15. We recognise there is some difficulty in considering this case, as the Trust has not been able to locate the records from the attendance in question. We have been able to obtain some evidence of the events on 10 February from the Trust’s online system, including the timing of actions, test results and observations. We also considered the records of Mrs O’s admission from 11 February, and the account provided by Mrs C.

16. Mrs O presented at the ED on 10 February with shortness of breath. Our adviser confirms this is a symptom suggestive of a pulmonary embolism (PE) and it was therefore a reasonable diagnosis to explore.

17. National Institute for Health and Care Excellence (NICE), National Guideline 158 is applicable here. It says: ‘For people who present with signs or symptoms of PE, such as chest pain, shortness of breath or coughing up blood, assess their general medical history, do a physical examination and offer a chest X-ray to exclude other causes’.

18. From the evidence we have obtained, we can see the Trust acted in line with the NICE guidance, having carried out a physical examination and taken a chest X-ray which was normal.

19. Mrs O’s observations were taken, and her National Early Warning Score (NEWS) was zero. The NEWS is a system where a score is allocated to six physiological parameters: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature. The higher the score, the greater the indication of deterioration in adult patients. Zero is the lowest score, indicating normal parameters and no clinical concern.

20. Returning to the NICE guidance, it says: ‘If PE is suspected, use the 2-level PE Wells score (table 2) to estimate the clinical probability of PE’. The table lists seven clinical features and the associated points each would score. The total gives the clinical probability, of whether PE is likely or unlikely. PE is considered likely for a total of more than four points, and unlikely with a score of four or less.

21. The guidance goes on as follows:

‘1.1.18 For people with a likely PE Wells score (more than 4 points): • offer a computed tomography pulmonary angiogram (CTPA) immediately if possible.

If a CTPA… scan cannot be done immediately, offer interim therapeutic anticoagulation.’

and

‘1.1.21 Offer people with an unlikely PE Wells score (4 points or less): • a D-dimer test with the result available within 4 hours if possible, or • if the D-dimer test result cannot be obtained within 4 hours (in any setting), offer interim therapeutic anticoagulation while awaiting the result.

If the D-dimer test result is positive, follow the actions in the recommendations 1.1.18’.

22. As the Trust has not been able to locate the records from the attendance in question, we do not know whether it assessed Mrs O as having a likely or unlikely PE Wells score. We can see that the Trust performed a D-dimer test, in line with the NICE guidance for an unlikely risk.

23. Mrs O’s D-dimer results were high. As outlined above, NICE guidance says if the D-dimer test is positive, meaning elevated, to follow the recommendations for a person with a likely PE Wells score. Therefore, regardless of whether Mrs O’s Wells score assessment resulted in a likely or unlikely probability for PE at the time, due to the Trust following the lower-risk NICE guidance recommendations, the resulting recommendations for the higher-risk then applied.

24. As we have outlined, these recommendations are to offer CTPA immediately, or if CTPA cannot be done immediately, to offer interim therapeutic anticoagulation. In giving Mrs O enoxaparin, the Trust followed the NICE guidance here.

25. Yet, we recognise Mrs C’s concern is that the Trust did not offer an immediate CTPA. Without the evidence within the records of the attendance, we cannot see what was considered and documented for the decision for anticoagulation and not immediate CTPA. It is entirely possible that anticoagulation was given because CTPA could not have been done immediately.

26. We acknowledge that without the evidence, we can never know. Yet, it remains that in the clinical situation we consider was applicable, the Trust’s management was appropriate and in line with the NICE guidance. The recommendation for anticoagulation is, importantly, an ‘or’ option set out within the guidance.

27. We know this will remain a considerable concern for Mrs C, and we hope to assure her we have considered this very carefully. Whilst we are without evidence of the attendance itself, we do have other pieces of evidence which we have taken into our consideration on this, to explain our thinking in more detail below.

28. From the evidence we have seen, our adviser explains that outside of her age, Mrs O was not presenting with any significant risk factors to indicate to us any apparent, urgent need for CTPA. Our adviser has carefully considered Mrs O’s observations and condition at the time. She was haemodynamically stable, meaning her cardiovascular system was functioning effectively, maintaining appropriate levels of blood pressure and flow around the body. Her pulse, temperature, oxygen saturations, respiratory rate and blood tests were also all within normal parameters.

29. It remains appropriate the Trust suspected PE. In this clinical situation, the risks and benefits must be very carefully balanced. Our adviser explains this is because the risk of not anticoagulating when a PE is suspected is very serious. They advise that the risk of not treating a potential PE whilst waiting for a CTPA means a patient’s condition could become significantly worse and increases the risk of sudden deterioration or death.

30. Our adviser also explains that with all hospital trusts, there is not always immediate access to a CT scanner and resources. Accordingly, the NICE guidance says to provide anticoagulation as appropriate management, and this is what the Trust did.

31. Whilst the following is not a requirement within the NICE guidance, our adviser provided additional information on an alternative assessment of risk, the pulmonary embolism severity index (PESI) score. We share this information here in the hopes of providing Mrs C with further reassurance.

32. The PESI score can be used to help clinicians consider whether it is clinically appropriate to discharge patients to return for a CT scan at a later time. It uses 11 clinical variables to determine risk. The higher the risk, the more likely the consideration to admit a patient over discharging them home. A score of less than 85 points would be low risk, supporting a decision to discharge the patient for outpatient or returned care. A score of over 85 would point to potentially considering a hospital admission.

33. Our adviser has been able to calculate a PESI score for Mrs O on 10 February, from the observations we find recorded within the evidence we could obtain. They explain Mrs O’s PESI score would have been 81. Whilst this may seem high, this score resulted from her age alone. Our adviser explained there were no other risk factors considered within the PESI assessment that contributed to Mrs O’s score.

34. From the contemporaneous evidence we do have, we can see Mrs O’s PESI score would have indicated she was at low risk. This further supports that the Trust’s decision to discharge Mrs O after providing anticoagulation and with plans in place for follow-up CT, was appropriate. The clinical information we see that was available at the time supports this, along with the action remaining aligned with the NICE guidance.

35. We know Mrs C is also concerned about the method of anticoagulation administration, that her mother received an injection of enoxaparin and not tablets.

36. There are different forms of anticoagulation medication, that can be given in different ways. An enoxaparin injection is classified as short-acting. Our adviser explains if a PE is confirmed, the method of enoxaparin may be switched to tablet form, as this is a longer-term option for the management of a blood clot.

37. Our adviser says an enoxaparin injection is considered the standard treatment in this clinical situation. As it is an injection it is shorter acting, and so if it is later determined a patient does not have a blood clot, it is a quicker way for this medication to no longer remain in a patient’s system.

38. We are mindful Mrs C has also raised concern that enoxaparin was given alongside her mother taking aspirin. Our adviser explains that aspirin is an antiplatelet drug that works on different parts of the blood clotting pathway. They confirmed that in line with British National Formulary recommendations, it is appropriate for a person to have both drugs concurrently. Although it is recognised both can cause some bleeding, when balancing the risks and benefits, our adviser confirms the risk of not treating a PE would outweigh the risks of bleeding.

39. We hope to assure Mrs C that the method of enoxaparin administration was appropriate to have given Mrs O, alongside her having taken aspirin, and was in line with both BNF recommendations and the NICE guidance.

1. We were very sorry to learn of Mrs C’s concern, that failings in her mother’s care at the Trust on 10 February 2024 caused a bleed on the brain, that led to her premature and avoidable death.

2. We have considered the evidence carefully and we do not see any indication of failings in the complaints raised with us. As we have seen no indication of wrongdoing, we have decided not to investigate further.

3. We recognise how important this complaint is to Mrs C. We understand what happened has caused and continues to cause her considerable distress, and we extend our condolences on the loss of her beloved mother. We explain our decision below.