Overview

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