CompletedPhase 4

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

Brazil32 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 80 years * Severe trauma patients (Index of Shock Severity \[ISS\] ≥ 15) * Hypotension (systolic blood pressure \< 90 mmHg) * Tachycardia (heart rate \> 100 bpm) * Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm) Exclusion Criteria: * Patient or family do not agree to sign the informed consent form * Eligible for institutional massive transfusion protocol * Pregnant * Previous coagulopathy disorders * Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin) * Previous thromboembolic disorders or events * Cardiopulmonary arrest before hospital admission * Patient admitted after another hospital transfer * Time from trauma to screening above six hours * Patients with exclusively traumatic brain injury

What they're measuring

Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization

Timeframe: 60 minutes

Trial details

NCT IDNCT02864875

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01

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