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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Bleeding Disorder Fibrinogen; Deficiency, Acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Not to receive an early replacement of fibrinogen

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Fibrinogen concentrate

Intervention Type DRUG

Receive fibrinogen concentrate 50mg/kg of body weight after randomization

Interventions

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Fibrinogen concentrate

Receive fibrinogen concentrate 50mg/kg of body weight after randomization

Intervention Type DRUG

Other Intervention Names

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Haemocomplettan®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No