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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02745041
Other study ID # FEISTY-1
Secondary ID
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
Health authority
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

Study Design


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
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