Evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage.

Not Applicable

Completed

• Conditions: Topic: Injuries and Emergencies, Haematology; Subtopic: Injuries and Emergencies (All Subtopics), Haematology (All Subtopics); Disease: Injuries and Emergencies, Non-malignant Haematology; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN67540073
• Lead Sponsor: HS Blood and Transplant (NHSBT)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29914530 results 2017 Protocol article in https://doi.org/10.1186/s13063-017-1980-x (added 12/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Study Completion: 2017-04-30
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Written informed consent or agreement, or waiver of consent, is obtained before any study related activity
2. The participant is judged to be an adult (aged 16 years or over) and is affected by traumatic injury
3. The participant is deemed by the attending clinician to have ongoing active haemorrhage with shock
AND REQUIRES:
4. Activation of the local major haemorrhage protocol for management of severe blood loss and/or transfusion of emergency (Group O) red cells

Exclusion Criteria

1. The participant has been transferred from another hospital
2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life
3. More than 3 hours have elapsed from the time of injury
4. The participant is pregnant
5. Severe isolated TBI or unsalvageable head injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 24/08/2018:<br> 1. Mean fibrinogen levels over time by treatment arm at admission, At 2 hours from admission during first active haemorrhage and 7 days from admission<br><br> Previous primary outcome measures:<br> 1. Feasibility of administering fibrinogen concentrate within 45 minutes of admission.<br> 2. Proportion of patients with at least one Clauss fibrinogen level = 2 g/L during active haemorrhage.<br>