Trauma Clinical Trial
Official title:
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
- 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
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Completed |
NCT04342416 -
Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
|
N/A | |
Recruiting |
NCT04856449 -
DBT Skills Plus EMDR for BPD and Trauma
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Completed |
NCT05669313 -
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
|
||
Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
Recruiting |
NCT04725721 -
Testing FIRST in Youth Outpatient Psychotherapy
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Not yet recruiting |
NCT03696563 -
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
|
N/A | |
Withdrawn |
NCT03249129 -
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
|
||
Completed |
NCT02240732 -
Surgical Tourniquets and Cerebral Emboli
|
N/A | |
Completed |
NCT02227979 -
Effects of PURPLE Cry Intervention
|
N/A | |
Withdrawn |
NCT01169025 -
Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT03112304 -
Child STEPS for Youth Mental Health in Maine Sustainability
|
N/A | |
Completed |
NCT01475344 -
Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)
|
Phase 1/Phase 2 | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Completed |
NCT01201863 -
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
|
Phase 4 |