Applying Results from Clinical Trials: Tranexamic Acid in Trauma Patients

Overview

Journal J Intensive Care

Publisher Biomed Central

Specialty Critical Care

Date 2015 Feb 24

PMID 25705414

Citations 12

Authors

Ian Roberts

David Prieto-Merino

Affiliations

Soon will be listed here.

Abstract

This paper considers how results from clinical trials should be applied in the care of patients, using the results of the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial of tranexamic acid in bleeding trauma patients as a case study. We explain why an understanding of the mechanisms of action of the trial treatment, and insight into the factors that might be relevant to this mechanism, is critical in order to properly apply (generalise) trial results and why it is not necessary that the trial population is representative of the population in which the medicine will be used. We explain why cause (mechanism)-specific mortality is more generalizable than all-cause mortality and why the risk ratio is the generalizable measure of the effect of the treatment. Overall, we argue that a biological insight into how the treatment works is more relevant when applying research results to patient care than the application of statistical reasoning.

Citing Articles

The Effectiveness of Prehospital Administration of Tranexamic Acid in Reducing Mortality in Trauma Patients: An Overview.

Javeed S, Altawili M, Almubarak L, Alaodah S, Alqarni M, Odeh O Cureus. 2024; 15(12):e49784.

PMID: 38161561 PMC: 10757764. DOI: 10.7759/cureus.49784.

State-by-state estimates of avoidable trauma mortality with early and liberal versus delayed or restricted administration of tranexamic acid.

Bivens M, Fritz C, Burke R, Schoenfeld D, Pope J BMC Emerg Med. 2022; 22(1):191.

PMID: 36463125 PMC: 9719138. DOI: 10.1186/s12873-022-00741-2.

Including random centre effects in design, analysis and presentation of multi-centre trials.

Edgar K, Roberts I, Sharples L Trials. 2021; 22(1):357.

PMID: 34022937 PMC: 8140487. DOI: 10.1186/s13063-021-05266-w.

Effect of tranexamic acid on intracranial haemorrhage and infarction in patients with traumatic brain injury: a pre-planned substudy in a sample of CRASH-3 trial patients.

Mahmood A, Needham K, Shakur-Still H, Harris T, Jamaluddin S, Davies D Emerg Med J. 2020; 38(4):270-278.

PMID: 33262252 PMC: 7982942. DOI: 10.1136/emermed-2020-210424.

A nested randomised trial of the effect of tranexamic acid on intracranial haemorrhage and infarction in traumatic brain injury (CRASH-3 trial intracranial bleeding mechanistic study): Statistical analysis plan.

Mahmood A, Roberts I, Shakur-Still H Wellcome Open Res. 2019; 3:99.

PMID: 31143842 PMC: 6530602. DOI: 10.12688/wellcomeopenres.14731.3.

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