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

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Trauma; Bleeding Disorder; Fibrinogen; Deficiency, Acquired

Treatments: Drug: Fibrinogen concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02864875

662.182

Details and patient eligibility

About

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.

Full description

This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Control

No Intervention group

Description:

Not to receive an early replacement of fibrinogen

Intervention

Experimental group

Description:

Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)

Treatment:

Drug: Fibrinogen concentrate