Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

NCT06582420 | Not Yet Recruiting DMC

• 1 other identifier: ULSAR2024
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.Administration feasibility of FC within the prehospital setting.

Conditions

Trauma Induced Coagulopathy

Keywords

Trauma; Coagulopathy; Trauma Induced Coagulopathy; Fibrinogen; Clot

Outcome Measures

Primary Outcomes (2)

• Plasma fibrinogen levels

  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.

  First 30 minutes on hospital arrival

• Administration feasibility

  Proportion of Patients Successfully Administered Fibrinogen Concentrate within 60 Minutes Post-Injury. This assessment aims to measure the proportion of eligible trauma patients who receive fibrinogen concentrate (FC) within 60 minutes of their injury. Feasibility will be determined by rigorously evaluating the time it takes to administer the treatment, adherence to the protocol, and any operational challenges encountered. Data will be meticulously compiled to calculate the average time it takes to administer the treatment, the rate of successful protocol adherence, and to identify common barriers to timely FC administration.

  Prehospital setting

Secondary Outcomes (8)

• Mortality

  Day 7 and day 28

• ICU Length of Stay

  Up to 90 days

• Multiple Organ Failure

  Up to 90 days

• Change of fibrinogen levels

  Day 1

• Change of clot stability upon arrival

  First 30 minutes on hospital arrival

Study Arms (2)

Standard trauma care

PLACEBO COMPARATOR

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 .

Drug: Standard trauma care

Standard trauma care plus administration of fibrinogen concentrate (FC).

EXPERIMENTAL

The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.

Drug: Fibrinogen concentrate

Interventions

Fibrinogen concentrate DRUG

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.

Standard trauma care plus administration of fibrinogen concentrate (FC).

Standard trauma care DRUG

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.

Standard trauma care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients at risk of Trauma Induced Coagulopathy (TIC), with major bleeding or presumed to be bleeding, identified by TIC criteria: mTICCS score \> 5 or Shock index \> 0.8.

You may not qualify if:

• Known adverse reactions to fibrinogen concentrate (FC)
• Isolated trauma such as traumatic head injury only
• Need for cardiopulmonary resuscitation (CPR) on the scene or peri-arrest scenarios
• Deep hypothermia
• Age below 18 years
• Pregnancy
• Prothrombin time ratio superior equal or superior to 1.2 (PTr\>1.2) at the hospital admission
• Refusal to participate (if the patients are capable of consenting)

Sponsors & Collaborators

• Unidade Local de Saude do Arco Ribeirinho: lead
• Unidade Local de Saúde de São José: collaborator
• Unidade Local de Saúde da Arrábida: collaborator
• Unidade Local de Saúde de Santa Maria: collaborator
• Unidade Local de Saúde Almada-Seixal: collaborator

Related Publications (19)

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• Innerhofer N, Treichl B, Rugg C, Fries D, Mittermayr M, Hell T, Oswald E, Innerhofer P, On Behalf Of The Retic Study Group. First-Line Administration of Fibrinogen Concentrate in the Bleeding Trauma Patient: Searching for Effective Dosages and Optimal Post-Treatment Levels Limiting Massive Transfusion-Further Results of the RETIC Study. J Clin Med. 2021 Aug 31;10(17):3930. doi: 10.3390/jcm10173930.

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MeSH Terms

Conditions

Wounds and Injuries; Hemostatic Disorders

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Study Officials

• Pedro Batarda Sena, MD

  Unidade Local de Saude do Arco Ribeirinho

  PRINCIPAL INVESTIGATOR

• Francisco Das Neves Coelho, MD

  Unidade Local de Saude do Arco Ribeirinho

  PRINCIPAL INVESTIGATOR

• Tiago Quaresma, MD

  Unidade Local de Saude do Arco Ribeirinho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Batarda Sena, MD

CONTACT

+351964794618; pmcbcs@gmail.com

Joana Alves Cabrita, MD

CONTACT

+351965139276; joana.alves.cabrita@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking will be applied to participants during all the stay and to care providers until randomly opaque envelopes are opened.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of fibrinogen concentrate (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. FC will be administered on-scene by prehospital teams as soon as possible, ideally within 60 minutes of injury. Randomization will be performed using sequentially numbered, sealed opaque envelopes. Blood samples will be taken at baseline, upon hospital admission, and at 24h after admission to measure fibrinogen levels and other coagulation parameters. At admission, the PTr and TIC score should be calculated.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share