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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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