Source · Prevention of Future Deaths
Maureen Waterfall
Ref: 2019-0455
Date: 30 Dec 2019
Coroner: Adrian Farrow
Area: Manchester (South)
Responses identified: 0 / 3
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There is no licensed antidote for Edoxaban anticoagulant, increasing risks for head injury patients. Concerns were raised about the lack of national guidance on antidote administration targets and storage, especially for non-tertiary hospitals.
Date
30 Dec 2019
56-day deadline
24 Feb 2020 est.
Responses identified
0 of 3
Coroner's concerns
There is no licensed antidote for Edoxaban anticoagulant, increasing risks for head injury patients. Concerns were raised about the lack of national guidance on antidote administration targets and storage, especially for non-tertiary hospitals.
View full coroner's concerns
In the circumstances it is my statutory to report to vou. _ heard evidence from Clinical Director of Neurosciences at Salford Royal Hospital: He told me that Edoxaban was one ofthe new anticoagulant drugs, but of those with which he is familiar, it is differentiated by the fact that there is no currently licensed antidote_ He is aware of clinical trials undertaken of such an antidote inquest was told that head injury patients who are prescribed Exodaban are at greater risk of continued bleeding to the brain than other patients as the absence ofa specific antidote makes the reversal of the anticoagulant medication less certain. As with other newer anticoagulant there is Iittle ability to monitor the effectiveness of the antidote. It was unclear if that understanding had been shared widely amongst non-tertiary centres to assist them in managing such patients. The inquest was told that,at SRFT which is a tertiary centre for neuro surgery/ neurology they have taken steps to set a target for the use of anticoagulant antidote at 90 minutes presentation. It was unclear if this target was feeding into development ofa national protocol: It was unclear how in the absence of national guidance that information was being shared with DGHs which rely on tertiary centres for expertise: At TGH there was no clear target time for the administration of anti-coagulations. heard that there is no national standard guidance about the storage of supplies of anticoagulant antidote As a result, as in this case at Tameside General Hospital Accident and Emergency Department they were not keptat the resuscitation unit; but rather they were kept in the haematology department
Report sections
Investigation and inquest
On the 2rd August 2019, an inquest was opened into the death of Maureen Waterfall, who died on 26th July 2019 at Willow Wood Hospice at Mellor Rd, Ashton-under-Lyne OL6 6SL, at the age of 72 years. The investigation concluded with an inquest which heard on 18th December 2019 and which concluded with a Conclusion that Mrs Waterfall died from the consequences of a brain injury sustained during a fall which were complicated by the previous use of prescribed Edoxaban:
Circumstances of the death
Mrs Waterfall had a successful heart operation at the Liverpool Heart and Chest Hospital in November 2018. As part of the post-operative treatment; an anticoagulant; Edoxaban, was prescribed. Mrs Waterfall fell at home on the morning of 12t July 2019 shortly before 9.OOam. She sustained an injury to the back of her head which bled and she went, accompanied by a friend, to the Accident and Emergency Department of Tameside General Hospital. She was seen in triage promptly and the inquest heard that the fact of her anticoagulant medication was noted and in consequence, because of the head injury, a CT scan was ordered at triage stage, rather than awaiting review by a doctor: The CT scan was performed at 12.07pm, but before the CT scan was reviewed by the A&E Consultant at the time of his examination of Mrs Waterfall at about 1.1Opm, Mrs Waterfall's condition deteriorated: The CT scan showed a subdural haematoma and she was moved to the resuscitation unit: After consultation with a neurosurgeon at Salford Roval Hospital and the haematologist at Tameside General Hospital and the decision was made to administer Prothrombin complex as an antidote to the Edoxaban: inquest heard that Edoxaban has no currently licensed antidote: Prothrombin complex is not specific to Edoxaban and its effectiveness is difficult to assess and monitor: The
Mrs Waterfall did not respond to the Prothrombin complex and her condition was such that when the second CT scan was reviewed, there was no surgical intervention which would have been viable ad she was moved to the intensive care unit at Tameside General Hospital: Whilst she had a period of brief raised consciousness the following her condition did not improve and she was transferred with the agreement of her family to Willow Wood Hospice on 15th where she remained until her death on 26t July 2019. A post mortem examination concluded that Mrs Waterfall died as a consequence of: 1Ja) Subdural haematoma
Mrs Waterfall did not respond to the Prothrombin complex and her condition was such that when the second CT scan was reviewed, there was no surgical intervention which would have been viable ad she was moved to the intensive care unit at Tameside General Hospital: Whilst she had a period of brief raised consciousness the following her condition did not improve and she was transferred with the agreement of her family to Willow Wood Hospice on 15th where she remained until her death on 26t July 2019. A post mortem examination concluded that Mrs Waterfall died as a consequence of: 1Ja) Subdural haematoma
Action should be taken
In my opinion action should be taken to prevent future deaths and believe you and your organisation have the power to take such action;
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underLyne OL6 9RW
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Report details
- Reference
- 2019-0455
- Date of report
- 30 December 2019
- Coroner
- Adrian Farrow
- Coroner area
- Manchester (South)
Responses identified
Responses identified
0 of 3
3 responses not yet linked
Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 24 Feb 2020 (estimated).
Sent to
- Department of Health and Social Care
- Greater Manchester Mental Health and Social Care
- National Institute for Health and Care Excellence