Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fibrinogen Early In Severe Trauma studY (FEISTY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02745041
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
Emergency Medicine Foundation
National Blood Authority
Australian Red Cross
Information provided by (Responsible Party):
Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service

Brief 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

Condition or disease Intervention/treatment Phase
Trauma Haemorrhage Coagulopathy Drug: Fibrinogen Concentrate Other: Cryoprecipitate Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
Study Start Date : December 2016
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Fibrinogen

Arm Intervention/treatment
Experimental: Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm]
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 Name: RIASTAP

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





Primary Outcome Measures :
  1. Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required [ Time Frame: 3 Hours ]
    It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation

  2. Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required [ Time Frame: 3 Hours ]
    Proportion of patients receiving FC within 30 minutes

  3. Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen [ Time Frame: 7 Days ]
    Blood sampling will occur for 7 days after admission/randomisation

  4. Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM [ Time Frame: 7 Days ]
    Blood sampling will occur for 7 days after admission/randomisation


Secondary Outcome Measures :
  1. Transfusion Requirements [ Time Frame: 48 hours ]
    In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs

  2. Duration of bleeding episode or time until surgical control [ Time Frame: 12 hours ]
    It is anticipated that haemorrhage control will be achieved within 12 hours

  3. Intensive Care Unit Length of stay [ Time Frame: 1 Year ]
  4. Hospital Length of Stay [ Time Frame: 1 Year ]
  5. Adverse Events [ Time Frame: 1Year ]
    Transfusion related adverse events Sepsis Multiple Organ Failure Acute Renal Failure Thromboembolic Complications

  6. All cause Mortality [ Time Frame: 90 Days ]
    Mortality at 4, 6, 24 hours and up to 90 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745041


Locations
Layout table for location information
Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Gold Coast University Hospital
Gold Coast, Queensland, Australia, 4215
Townsville Hospital
Townsville, Queensland, Australia, 4814
Sponsors and Collaborators
Gold Coast Hospital and Health Service
Emergency Medicine Foundation
National Blood Authority
Australian Red Cross
Investigators
Layout table for investigator information
Principal Investigator: James Winearls, MBBS Gold Coast University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Consultant Intensivist, GCUH ICU, Gold Coast Hospital and Health Service
ClinicalTrials.gov Identifier: NCT02745041     History of Changes
Other Study ID Numbers: FEISTY-1
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service:
Fibrinogen
Cryoprecipitate

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders