Fibrinogen Early In Severe Trauma studY

Trauma Clinical Trial

— FEISTY  

Official title:

Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745041
• Other study ID #: FEISTY-1
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2016
• Last updated: March 2, 2018
• Start date: December 2016
• Est. completion date: February 20, 2018

Study information

• Verified date: March 2018
• Source: Gold Coast Hospital and Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulopathy
• Haemorrhage
• Hemorrhage
• Hemostatic Disorders
• Trauma

Intervention

Drug:
• 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

Other:
• 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

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Gold Coast University Hospital	Gold Coast	Queensland
Australia	Townsville Hospital	Townsville	Queensland

Sponsors (4)

Lead Sponsor	Collaborator
Gold Coast Hospital and Health Service	Australian Red Cross, Emergency Medicine Foundation, National Blood Authority

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required	It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation	3 Hours
Primary	Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required	Proportion of patients receiving FC within 30 minutes	3 Hours
Primary	Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen	Blood sampling will occur for 7 days after admission/randomisation	7 Days
Primary	Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM	Blood sampling will occur for 7 days after admission/randomisation	7 Days
Secondary	Transfusion Requirements	In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs	48 hours
Secondary	Duration of bleeding episode or time until surgical control	It is anticipated that haemorrhage control will be achieved within 12 hours	12 hours
Secondary	Intensive Care Unit Length of stay		1 Year
Secondary	Hospital Length of Stay		1 Year
Secondary	Adverse Events	Transfusion related adverse events Sepsis Multiple Organ Failure Acute Renal Failure Thromboembolic Complications	1Year
Secondary	All cause Mortality	Mortality at 4, 6, 24 hours and up to 90 days	90 Days