Title {1}	Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study.
Trial registration {2a and 2b}.	Clinical trial, NCT03218722
Protocol version {3}	Date: February 6th 2019, Version: 6.0
Funding {4}	PROCOAG is an investigator-initiated trial, supported by a non-profit grant from the French Ministry of Health (PHRCI 2015, n°15-059). LFB (Les Ullis, France) is the manufacturer of the pharmaceutical product used in the trial and distributes Kanokad® for free to participating centers.
Author details {5a}	Pr. Pierre Bouzat and Pr. Jean-François Payen : Pôle Anesthésie-Réanimation, Centre Hospitalo-Universitaire Grenoble-Alpes, Grenoble, France Pr. Jean-Luc Bosson : Univ. Grenoble Alpes, CNRS, Public Health department CHU Grenoble Alpes, TIMC-IMAG, 38000 Grenoble, France Pr. Jean-Stéphane David : Service d’Anesthésie Réanimation, Centre Hospitalo-Universitaire Lyon-Sud, Faculté de Médecine Lyon-Est, Université Claude Bernard Lyon 1, Lyon, France Pr. Bruno Riou : Sorbonne Université, UMRS INSERM 116, IHU ICAN, et Service des urgences, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France Pr. Jacques Duranteau : Département d’Anesthésie-Réanimation, Hôpitaux Universitaires Paris Sud, Université Paris XI, Faculté de Médecine Paris-Sud, Le Kremlin-Bicêtre, France.
Name and contact information for the trial sponsor {5b}	French Ministry of Health, GIRCI AURA, 3 Quai des Célestins, 69002 Lyon, France. PHRCI 2015, n°15-059
Role of sponsor {5c}	Funders have no role in trial design, conduction, data collection, nor analysis. Kanokad® safety aggregated data are shared with LFB.