Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage needing haemostatic resuscitation - a randomized, controlled, double-blinded investigator-initiated pilot trial

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: CSL Behring
• Treatments: Hemostatics

Criteria

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 1st 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:

• 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 one 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