Randomisation into the CRASH-3 trial

Abda Mahmood; Ian Roberts; Haleema Shakur

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Randomisation into the CRASH-3 trial

AM Abda Mahmood

IR Ian Roberts

HS Haleema Shakur

This method is extracted from research article: Trials, Jul 2017

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS])

DOI: 10.1186/s13063-017-2073-6

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TBI patients eligible for inclusion into the CRASH-3 trial are randomly allocated to receive tranexamic acid or matching placebo (0.9% sodium chloride) and the trial treatment is started as soon as possible. Patients are randomised by selecting the lowest available numbered pack from a block of eight treatment packs. Randomisation codes are generated with a computer random number generator. There is no need to withhold any clinically indicated treatment in the CRASH-3 trial. Tranexamic acid or placebo is provided as an additional treatment to the usual management of TBI. The loading dose of the trial treatment is administered by intravenous injection immediately after randomisation (within minutes). The maintenance dose (by intravenous infusion) should start as soon as the loading dose is completed.

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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