drugset / Trial / NCT02864875

Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial

NCT02864875

Phase 4 Completed 32 enrolled University of Sao Paulo General Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.

Timeline

Start
2015-12
Primary completion
2017-01
Completion
2018-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 50 mg/kg