Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH): study protocol for a randomized controlled trial

Discussion Patients considered to be included in the trial will temporarily have a compromised consciousness because of the acute, critical bleeding related to trauma, so scientific guardians will co-sign the informed consent form. Next of kin and the patients’ general practitioner or the patients will co-sign as soon as possible. This trial will test whether immediate pre-emptive fibrinogen concentrate administered to adult trauma patients as first-line treatment of trauma haemorrhage will increase the clot strength as evaluated by thrombelastography, transfusion requirements and survival in patients receiving haemostatic resuscitation according to current standard of care. Trial registration EudraCT no. 2014-003978-16 (22/1 2015); ClinicalTrials.gov: NCT02344069. Registered on 14 January 2015. Trial protocol version 4.2 (23-12-2014).
Source: Trials - Category: Research Source Type: clinical trials