Fibrinogen Early In Severe Trauma studY

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients
* Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
* Hypo/dysfibrinogenaemia plays an important role in TIC
* Early replacement of fibrinogen may improve outcomes
* Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
* The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
* Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
* It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
* Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
* Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay
* No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients
* Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm
* It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation)
* Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate
* It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fibrinogen Early In Severe Trauma studY Junior

NCT03508141

Trauma Hemorrhage Coagulopathy +1 more

UNKNOWN PHASE2

Fibrinogen Early In Severe Trauma StudY II

NCT05449834

Trauma Haemorrhagic Shock Coagulopathy

RECRUITING PHASE3

Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

NCT06582420

Trauma Induced Coagulopathy

NOT_YET_RECRUITING NA

Factor In the Initial Resuscitation of Severe Trauma 2 Patients

NCT04534751

Traumatic Hemorrhage Coagulopathy Massive Hemorrhage

UNKNOWN PHASE4

Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol

NCT03354559

Major Trauma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trauma Haemorrhage Coagulopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fibrinogen Concentrate

Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM ≤ A5 10mm\]

Group Type EXPERIMENTAL

Fibrinogen Concentrate

Intervention Type DRUG

Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM ≤ A5 10mm\]

FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC

Cryoprecipitate

Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 ≤ 10mm\]

Group Type ACTIVE_COMPARATOR

Cryoprecipitate

Intervention Type OTHER

Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 ≤ 10mm\]

FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fibrinogen Concentrate

Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM ≤ A5 10mm\]

FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC

Intervention Type DRUG

Cryoprecipitate

Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 ≤ 10mm\]

FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RIASTAP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult affected by Trauma (\>18yrs) and
2. Judged to have significant haemorrhage or
3. Predicted to require significant transfusion with ABC Score ≥ 2 or by treating clinician judgement

Exclusion Criteria

1. Injury judged incompatible with survival
2. Pregnancy
3. Known objection to blood products
4. Previous Fibrinogen replacement this admission
5. Pre-Trauma Centre fibrinogen replacement
6. Participation in competing study

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No