Acknowledgements | Tranexamic acid to reduce head injury death in people with traumatic brain injury: the CRASH-3 international RCT

Tranexamic acid to reduce head injury death in people with traumatic brain injury: the CRASH-3 international RCT · Acknowledgements

Acknowledgements

We would like to acknowledge and thank the significant contribution made by our oversight committees in guiding the trial.

Trial Steering Committee

Peter Sandercock (Chairperson), Henry Benjamin Hartzenberg, Manjul Joshipura (2011–16), Amy Aeron-Thomas (Patient Representative), Ian Roberts, Pablo Perel and Haleema Shakur-Still.

Data Monitoring Committee

Michael J Clarke (Chairperson), Samuel C Ohaegbulam, Anthony Rodgers and Tony Brady (Independent Statistician).

We would especially like to thank the patients and their families who had to make the decision in a critical emergency to take part in this trial.

Contributions of authors

Ian Roberts (https://orcid.org/0000-0003-1596-6054) (Professor of Epidemiology and Public Heath) was involved in the design, conduct, analysis and reporting phases of the study.

Haleema Shakur-Still (https://orcid.org/0000-0002-6511-109X) (Professor of Global Health Clinical Trials) was involved in the design, conduct, analysis and reporting phases of the study.

Amy Aeron-Thomas (https://orcid.org/0000-0002-2379-5833) (Advocacy and Justice Manager, RoadPeace) was involved in the design, conduct, analysis and reporting phases of the study.

Danielle Beaumont (https://orcid.org/0000-0002-2530-9608) (Senior Trial Manager/Research Fellow) was involved in the conduct and reporting phases of the study.

Antonio Belli (https://orcid.org/0000-0002-3211-9933) (Professor of Trauma Neurosurgery) was involved in the design, conduct, analysis and reporting phases of the study.

Amy Brenner (https://orcid.org/0000-0003-2017-5994) (Research Fellow in Epidemiology) was involved in the analysis and reporting phases of the study.

Madeleine Cargill (https://orcid.org/0000-0001-9050-877X) (Data Assistant) was involved in the conduct phase of the study.

Rizwana Chaudhri (https://orcid.org/0000-0002-5428-3988) (Dean and Professor of Obstetrics and Gynaecology) was involved in the conduct and reporting phases of the study.

Nicolas Douglas (https://orcid.org/0000-0002-2921-4198) (Research Fellow) was involved in the design phase of the study.

Lauren Frimley (https://orcid.org/0000-0002-2478-348X) (Trial Manager/Research Assistant) was involved in the conduct and reporting phases of the study.

Catherine Gilliam (https://orcid.org/0000-0003-4010-7139) (Trial Administrator) was involved in the conduct phase of the study.

Amber Geer (https://orcid.org/0000-0001-5126-1436) (Assistant Data Manager) was involved in the conduct phase of the study.

Zahra Jamal (https://orcid.org/0000-0002-3817-6795) (Trial Assistant) was involved in drafting this report.

Rashid Jooma (https://orcid.org/0000-0001-6627-3245) (Professor of Neurosurgery) was involved in the conduct and reporting phases of the study.

Raoul Mansukhani (https://orcid.org/0000-0002-9456-5859) (Research Fellow in Medical Statistics) was involved in the analysis and reporting phases of the study.

Alec Miners (https://orcid.org/0000-0003-1850-1463) (Associate Professor in Health Economics) was involved in the analysis and reporting phases of the study.

Jason Pott (https://orcid.org/0000-0003-2068-0560) (Lead Research Nurse for Emergency Medicine) was involved in the conduct and reporting phases of the study.

Danielle Prowse (https://orcid.org/0000-0002-7470-4823) (Assistant Data Manager) was involved in the conduct phase of the study.

Temitayo Shokunbi (https://orcid.org/0000-0002-7819-6862) [Professor of Anatomy (joint appointment with surgery) and Consultant Neurological Surgeon] was involved in the conduct and reporting phases of the study.

Jack Williams (https://orcid.org/0000-0002-1331-387X) (Research Fellow in Health Economics) was involved in the analysis and reporting phases of the study.

All authors made substantial contributions to conception and design of the study, or the acquisition, analysis and interpretation of data. All authors were involved in the drafting of the manuscript or revising it critically, and all authors approved the final version to be published.

Publications

The CRASH-3 trial collaborators. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet 2019;394:1713–23.

Brenner A, Belli A, Chaudhri R, Coats T, Frimley L, Jamaluddin SF, et al. Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial. Crit Care 2020;24:560.

Mansukhani R, Frimley L, Shakur-Still H, Sharples L, Roberts I. Accuracy of time to treatment estimates in the CRASH-3 clinical trial: impact on the trial results. Trials 2020;21:681.

Williams J, Roberts I, Shakur-Still H, Lecky FE, Chaudhri R, Miners A. Cost-effectiveness analysis of tranexamic acid for the treatment of traumatic brain injury, based on the results of the CRASH-3 randomised trial: a decision modelling approach. BMJ Global Health 2020;5:e002716.

Data-sharing statement

After publication of the planned primary and secondary analyses, the totally anonymised trial data will be made available via our data-sharing portal, the Free Bank of Injury and emergency Research Data (freeBIRD) website (http://freebird.lshtm.ac.uk). Please contact the corresponding author for more information.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone’s privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care.

Attribution. Ian Roberts; Haleema Shakur-Still; Amy Aeron-Thomas; Danielle Beaumont; Antonio Belli; Amy Brenner et al. (2021). Tranexamic acid to reduce head injury death in people with traumatic brain injury: the CRASH-3 international RCT. NIHR Journals Library. Copyright © 2021 Roberts et al. This work was produced by Roberts et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Licensed under CC BY 4.0. NCBI Bookshelf NBK570193. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.