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Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage

NCT02344069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-11

No results posted yet for this study

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

Conditions

Interventions

DRUG

Fibrinogen

Human fibrinogen concentrate as a injection

DRUG

Placebo

Saline 0.9% as a injection

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Jakob Stensballe, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344069 on ClinicalTrials.gov