Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

Summary

A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.

The main endpoints are:

1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
2. Administration feasibility of FC within the prehospital setting.

Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.

Conditions

• Trauma Induced Coagulopathy

Interventions

DRUG

Fibrinogen concentrate

Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC. The standard of care is determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide. The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.

DRUG

Standard trauma care

Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC. The standard of care is determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide. The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.

Sponsors & Collaborators

• Unidade Local de Saúde de São José

  collaborator UNKNOWN

• Unidade Local de Saúde da Arrábida

  collaborator UNKNOWN

• Unidade Local de Saúde de Santa Maria

  collaborator UNKNOWN

• Unidade Local de Saúde Almada-Seixal

  collaborator UNKNOWN

• Unidade Local de Saude do Arco Ribeirinho

  lead OTHER_GOV

Principal Investigators

• Pedro Batarda Sena, MD · Unidade Local de Saude do Arco Ribeirinho

• Francisco Das Neves Coelho, MD · Unidade Local de Saude do Arco Ribeirinho

• Tiago Quaresma, MD · Unidade Local de Saude do Arco Ribeirinho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2025-08-31

Completion

2025-12-31