Skip to main content

Table 1 Selection criteria

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

Inclusion criteria
• Trauma patient received directly from the scene of the accident AND
• Age ≥18 years AND
• Initiated order of transfusion of at least one blood component within the first hour of arrival AND
• Predicted to need transfusion package therapy during the initial resuscitation (first 2 hours) AND
• Consent obtainable from patient or scientific guardians (independent physicians and/or next of kin)
Exclusion criteria
Patients are not eligible for inclusion in this trial if they fulfill one or more of the following criteria:
• Duration of >2 hours from time of accident to arrival at trauma centre OR
• Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxiban, apixaban) OR
• Severe isolated traumatic brain injury OR
• Moribund patient with devastating injuries and expected to die within 1 hour of admission OR
• Withdrawal from active therapy OR
• Previously, within 30 days, included in a randomized trial, if known at the time of enrolment OR
• Known body weight <55 kg OR
• Any blood product prior to inclusion