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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