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Clinical Trials/ISRCTN67540073
ISRCTN67540073
Completed
未知

A multi-centre, randomised, double blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage.

HS Blood and Transplant (NHSBT)0 sites48 target enrollmentAugust 6, 2015
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ConditionsTopic: Injuries and Emergencies, HaematologySubtopic: Injuries and Emergencies (All Subtopics), Haematology (All Subtopics)Disease: Injuries and Emergencies, Non-malignant HaematologyInjury, Occupational Diseases, Poisoning

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Injuries and Emergencies, Haematology
Sponsor
HS Blood and Transplant (NHSBT)
Enrollment
48
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)

Registry
who.int
Start Date
August 6, 2015
End Date
April 30, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
HS Blood and Transplant (NHSBT)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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