Source · Prevention of Future Deaths

Jeffrey Marshall

Ref: 2024-0450 Date: 13 Aug 2024 Coroner: Anna Loxton Area: Surrey Responses identified: 2 / 2 View PDF

A lack of national guidance on when to recommence anticoagulation after a traumatic head injury and no requirement to discuss risks with patients creates uncertainty and impacts informed decision-making.

Date 13 Aug 2024
56-day deadline 8 Oct 2024 est.
Responses identified 2 of 2
Hospital Death (Clinical Procedures and medical management) related deaths

Coroner's concerns

AI summary
A lack of national guidance on when to recommence anticoagulation after a traumatic head injury and no requirement to discuss risks with patients creates uncertainty and impacts informed decision-making.
View full coroner's concerns
Mr Marshall was prescribed anticoagulation (Edoxaban) to mitigate his increased risk of developing thrombus due to atrial fibrillation and a permanent pacemaker;
- Anticoagulation was withheld following a traumatic head injury, in accordance with NICE guidance;
- There is no national guidance to assist clinicians in determining when anticoagulation should be recommenced in this scenario, nor any recommendation for clinicians to discuss the risks and benefits of withholding anticoagulation with patients to enable them to make an informed decision as to when to recommence anticoagulation.

Consideration should be given to whether any steps can be taken to address the above concerns.

Responses

2 respondents
NHS England NHS / Health Body
13 Aug 2024 PDF
Noted

NHS England acknowledges the coroner's concerns but states that NICE is the appropriate body to provide clinical guidance. NHS England will review NICE's response and consider any resultant actions, while noting the need for individualised care in such cases. They are also gathering information on a delay in reporting a CT scan result. (AI summary)

View full response
Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Jeffrey Marshall who died on 13 December 2023

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 13 August 2024 concerning the death of Jeffrey Marshall on 13 December 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Jeffrey’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Jeffrey’s care have been listened to and reflected upon.

I am grateful for the further time granted to respond to respond to your Report, and I apologise for any anguish this delay may have caused to Jeffrey’s family or friends. I realise that responses to Coroner Reports can form part of the important process of family and friends coming to terms with what has happened to their loved ones and appreciate this will have been an incredibly difficult time for them.

Your Report raised the concern that there is no national guidance to assist clinicians in determining when anticoagulation should be recommenced following a traumatic head injury, nor any recommendation for clinicians to discuss the risks and benefits of withholding anticoagulation with their patients.

I note, in addition to NHS England, that your Report has been addressed to the National Institute for Health and Care Excellence (NICE). They are the appropriate organisation to respond to the Coroner’s concerns, as the provider of the relevant clinical guidance. NHS England will carefully review NICE’s response to the Coroner in due course, and consider whether any resultant actions are required from us.

It should however be noted that there will need to be a significant degree of individualised care and decision-making in cases such as Jeffrey’s. There will need to be careful consideration of the risks of atrial fibrillation stroke versus the risk of precipitating bleeding (dependent on different patient factors), and that this could provide challenge to producing specific guidance on this issue.

It is difficult for NHS England to provide more detailed comments on the quality of care delivered to Jeffrey based on the information in your Report. However, we do note that there looks to have been a significant delay between the second CT scan being taken National Director of Patient Safety NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

6 November 2024

on 8 November 2023 and the results being reported on 3 December 2023, and that it is possible this could have delayed any decisions on whether to restart Jeffrey’s anticoagulation medication. My colleagues in the South East region have been asked to gather further information on this, as part of our Regulation 28 assurance processes.

I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Jeffrey, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.
National Institute for Health and Care Excellence Other
3 Oct 2024 PDF
Action Planned

NICE acknowledges the lack of specific guidance on restarting anticoagulants after traumatic intracranial haemorrhage. NICE will consider the issues raised through their guidelines surveillance process and discuss a consensus statement with relevant specialist societies. (AI summary)

View full response
Dear Ms Loxton, Re: Regulation 28 Prevention of Future Deaths Report in respect of Jeffrey Marshall I write in response to your regulation 28 report dated 13 August 2024 regarding the sad death of Jeffrey Marshall. I would like to express my sincere condolences to Mr Marshall’s family. We have reflected on the circumstances surrounding Mr Marshall’s death and the concerns raised in your report. We note your concerns that Mr Marshall’s anticoagulation medication was withheld following a traumatic head injury, in accordance with NICE guidance, and that there is no national guidance to assist clinicians in determining when anticoagulation should be recommenced in this scenario, nor any recommendation for clinicians to discuss the risks and benefits of withholding anticoagulation with patients to enable them to make an informed decision as to when to recommence anticoagulation. Following receipt of your report, senior clinical advisers within our patient safety team have reviewed the concerns raised. They have outlined that there are no specific NICE recommendations that cover the question of when to restart antithrombotic therapies in patients following traumatic intracranial haemorrhage or anything that would help to inform a conversation with the patient about this. The NICE guideline, Head injury: assessment and early management [NG232], gives guidance on when to perform a CT scan and on referral and admission, but not on withholding, substituting or restarting anticoagulants in this situation. In the NICE guideline, venous thromboembolism in over 16s: reducing the risk of hospital- acquired deep vein thrombosis or pulmonary embolism [NG89], in relation to cranial surgery, it states; ‘Do not offer pharmacological VTE prophylaxis to people with ruptured cranial vascular malformations (for example, brain aneurysms) or people with intracranial haemorrhage (spontaneous or traumatic) until the lesion has been secured or the condition has stabilised. (emphasis, recommendation 1.12.10) and, in relation to major trauma ‘Consider pharmacological VTE prophylaxis for people with serious or major trauma as soon

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as possible after the risk assessment when the risk of VTE outweighs the risk of bleeding’. Although these situations are not the same as those of Mr Marshall, the inference is towards not restarting anticoagulants until there has been a risk assessment. Our senior clinical advisers have outlined that there is also various external literature on this subject, however this area is complex, as the risk to patients will depend on the baseline risk from the underlying reason that they were on anticoagulants in the first place, the severity and cause (traumatic or spontaneous) of the bleeding episode itself, whether any reversal agents were used and any immobility after the acute event and in the recovery phase. Unfortunately, there is very little research evidence on which guidelines relevant to this complex decision could be based, and a high degree of clinical judgement is required in each individual person’s case. We have considered whether there is enough consensus opinion or any expert guidelines that inform (or in this case, should have informed) clinicians in the management of Mr Marshall. Our clinical advisers’ review suggests that current guidelines do not address the issue of when to restart anticoagulants after traumatic intracranial haemorrhage. In summary, we agree that this specific question is not well covered by current guidance. NICE will consider the issues raised through our guidelines surveillance team and process, and update or issue new guidance recommendations, accordingly, depending on the outcome of these considerations. We will also discuss with relevant specialist societies the possibility of reaching a consensus statement on this subject. I hope this response is helpful in confirming the actions that we will take as a result of your report relating to Mr Marshall and would like to reiterate my condolences to his family.

Report sections

Investigation and inquest
The inquest into the death of Jeffrey MARSHALL was opened on 4th January 2024. Evidence was heard and the inquest was concluded on 13th June 2024. Mr Marshall died at St Peter’s Hospital in Chertsey on 13th December 2023, aged 72 years. I found the medical cause of death to be: 1a. Ischaemic Stroke 1b. Thrombosis of Basilar Artery 1c. Atherosclerosis of Basilar Artery
2. Previous Subdural Haematoma; Hypertension; Diabetes Mellitus; Atrial Fibrillation; Cessation of Anticoagulation Therapy

I found that whilst the cause of death was natural, it was contributed to by the withholding of anticoagulation therapy over the previous 47 days prior to death. Mr Marshall had sustained a subdural haematoma in a fall on 21st October 2023, following which his anticoagulation therapy was
Circumstances of the death
Mr Marshall died from an ischaemic stroke at St Peter’s Hospital in Chertsey on 13th December 2023. He had suffered a fall whilst exiting a car on 21st October 2023, in which he sustained an acute subdural haematoma. His anticoagulation therapy of Edoxaban, prescribed for atrial fibrillation and permanent pacemaker, was withheld in accordance with NICE guidance. Neurosurgeons at St George’s Hospital in Tooting gave advice and reiterated the need to withhold anticoagulation and to monitor the bleed via further CT scan the following day, and again two weeks thereafter. The last scan on 8th November 2023 revealed that the haematoma had resolved, but this was requested on a routine basis with a reporting time of 28 days. It was therefore reported on Sunday 3rd December, and Mr Marshall’s GP was advised that anticoagulation could be restarted on 6th December 2023. Mr Marshall suffered a sudden loss of consciousness at home on the evening of 7th December 2023 and was admitted to St Peter’s Hospital, where he was found
Copies sent to
1. See names in paragraph 1 above

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Report details

Reference
2024-0450
Date of report
13 August 2024
Coroner
Anna Loxton
Coroner area
Surrey

Responses identified

Responses identified 2 of 2
All listed responses identified

Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 8 Oct 2024 (estimated).

Sent to

National Institute for Health and Care Excellence
NHS England

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