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Original research
Four-factor prothrombin complex concentrate versus andexanet alfa for the reversal of traumatic brain injuries
  1. Erin Sadek1,
  2. William Curtiss2,
  3. Jessica Andrews3,
  4. Jason Hecht1
  1. 1Inpatient Pharmacy, Trinity Health Ann Arbor, Ann Arbor, Michigan, USA
  2. 2Trauma, Acute and Critical Care Surgery, Trinity Health Ann Arbor, Ann Arbor, Michigan, USA
  3. 3Inpatient Pharmacy, University of Michigan, Michigan Medicine, Ann Arbor, Michigan, USA
  1. Correspondence to Dr Jason Hecht; jason.hecht{at}trinity-health.org

Abstract

Background Andexanet alfa was approved in 2018 for reversal of direct oral anticoagulants but due to issues of cost and access, four-factor prothrombin complex concentrate (4F-PCC) continues to be used for this indication. The objective of this study is to evaluate outcomes of reversal with these agents in patients with isolated traumatic brain injuries (TBI).

Methods This is a retrospective review of 35 trauma centres from 2014 to 2021. Patients were included with an Abbreviated Injury Scale (AIS)>2 for head and having received andexanet alfa or 4F-PCC within 24 hours of admission. Patients were excluded if P2Y12 inhibitor use or AIS>2 outside of head. Primary outcome includes rate of mortality/hospice at hospital discharge. Secondary outcomes include a composite of serious hospital complications. A subgroup analysis of severe TBI patients (AIS head 4 or 5) was completed. Multivariable logistic regression was used to account for differences in comorbidities and TBI severity.

Results 4F-PCC was given to 265 patients with another 59 receiving andexanet alfa. Patients in the andexanet alfa group were more likely to have an AIS head score of 5 (47.5% vs 26.1%; p<0.005). After adjusting for severity of TBI and comorbidities with regard to mortality/hospice, there were 15 (25.4%) patients in the andexanet alfa group and 49 (18.5%) in the 4F-PCC group (OR 1.34; 95% CI 0.67 to 2.71). This remained consistent when looking at severe TBI patients with 12 (28.6%) andexanet alfa patients and 37 (28.7%) 4F-PCC patients (OR 0.93 (95% CI 0.40 to 2.16)). Severe hospital complications were also similar between groups with 5 (8.5%) andexanet alfa patients as compared with 21 (7.9%) 4F-PCC patients (OR 1.01; 95% CI 0.36 to 2.88).

Conclusion There was no firm conclusion on the treatment effect in mortality/hospice or serious complications among isolated TBI patients reversed with 4F-PCC as compared with andexanet alfa.

  • critical care
  • craniocerebral trauma
  • accidental falls

Data availability statement

Data may be obtained from a third party and are not publicly available. Data were obtained from the Michigan Trauma Quality Improvement Program database, which are available to clinicians from all participating trauma centres. The data are not publically available but deidentified data can be made available upon reasonable request by contacting the corresponding author or Mark Hemmila (mhemmila@med.umich.edu).

https://doi.org/10.1136/emermed-2023-213229

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    Data availability statement

    Data may be obtained from a third party and are not publicly available. Data were obtained from the Michigan Trauma Quality Improvement Program database, which are available to clinicians from all participating trauma centres. The data are not publically available but deidentified data can be made available upon reasonable request by contacting the corresponding author or Mark Hemmila (mhemmila@med.umich.edu).

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    Footnotes

    • Handling editor Carl Marincowitz

    • Correction notice Since this paper first published online, a reference to ANEXA has been updated to read ANNEXA. Reference 17 has been removed as it was a duplicate of reference 10. In the discussion section the sentence ' 'usual care' consisted of no treatment at all' has been updated to read ' 'usual care' included no care at all.

    • Contributors The authors confirm contribution to the paper as follows: study conception and design: JH, ES, WC, JA; data collection: JA, JH. Author; analysis and interpretation of results: JH, ES, WC, JA; draft manuscript preparation: JA, ES, JH. guarantor and responsibility for the overall content: JH. All authors reviewed the results and approved the final version of the manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer-reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.