Coagulopathy Clinical Trial
— FiiRST-2Official title:
Prospective, Multi-center, Randomized, Parallel-control, Superiority Study Comparing Administration of Clotting Factor Concentrates With a Standard Massive Hemorrhage Protocol in Severely Bleeding Trauma Patients.
Injury is the leading cause of death for people between the ages of 1-44. This is especially true in trauma patients who have bleeding complications. Acute trauma coagulopathy (ATC) is associated with high transfusion requirements, longer ICU stays, and a greater incidence of multi-organ dysfunction. The cause of coagulopathy is multi-factorial. One major driver is acquired fibrinogen deficiency (hypofibrinogenemia). Fibrinogen is critical in clot formation and enhances platelet aggregation. Due to the body's limited reserve, it is the first clotting factor to fall to critical levels during life-threatening bleeding. This can impair coagulation and increases bleeding complications. There are two primary options available for fibrinogen supplementation: - Cryoprecipitate- North American standard - Fibrinogen Concentrate (FC)- European standard Consumption of coagulation factors, including fibrinogen, is another important component of ATC. To replenish these depleted coagulation factors and improve thrombin generation, two therapies are available: - Frozen Plasma (FP)- North American standard - Prothrombin Complex Concentrate (PCC)- European standard Strategies for hemorrhage and coagulopathy treatment have changed significantly over the last decade. Prompt hemorrhage control, along with targeted coagulation factor replacement, are emerging as key components of trauma care. Currently, the initiation of a massive hemorrhage protocol (MHP) results in red blood cells (RBCs) and FP transfusions in a 1:1 or 2:1 ratio. Clotting factors are replaced via FP administration. Fibrinogen supplementation is administration after lab verification or at the clinician's discretion. MHP continues until the rate of hemorrhage is under control. FC and PCC have several important advantages over cryoprecipitate and FP but there is a scarcity of data regarding their efficacy and safety of their use in hemorrhaging trauma patients. The FiiRST-2 study aims to understand if early use of FC and PCC in trauma patients at risk of massive hemorrhage will lead to superior patient outcomes. This trial will also provide safety data on early administration of FC and PCC as a first-line hemostatic therapy in trauma care, and its impact on hemostatic and other clinical endpoints.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: Severely injured adult trauma patients who meet all following criteria: 1. Estimated age greater than 16 years old 2. Severely injured (penetrating or blunt) trauma patients 3. Triggered MHP within first hour of hospital arrival at the trauma bay/ED Exclusion Criteria: Patients who meet any of the following criteria are not eligible for the study: 1. Have received more than 2 U RBCs during the pre-hospital phase of care 2. Have received more than 2 U RBCs in the trauma bay/ED before activation of the MHP 3. Have an elapsed time from injury of more than 3 hours 4. Have a penetrating traumatic brain injury with Glasgow Coma Scale (GCS) of 3 5. Are suspected or known to be on anticoagulants in the last 7 days 6. Have known congenital or acquired bleeding disorders 7. Have a known pregnancy 8. Refuse blood transfusion due to religion or other reasons 9. Previous history of heparin induced thrombocytopenia (HIT) |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences and McMaster University | Hamitlon | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Victoria Hospital | London | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institute for Military and Veteran Health Research Defense Research & Development Canada, Canadian Institutes of Health Research (CIHR), Octapharma, Sunnybrook Health Sciences Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of total number of Allogeneic Blood Products (ABPs) | The primary endpoint is to demonstrate superiority with respect to the composite number of all ABP units (RBCs, FP and platelets) transfused | within 24 hours | |
Secondary | Total number of RBC units | RBC - Red Blood Cells | Transfused within the 24 hours | |
Secondary | Incidence of thromboembolic events | Defined by evidence of any of the following:
Deep vein thrombosis (DVT) Pulmonary embolism (PE) Myocardial infarction (MI) Ischemic stroke o. Arterial or venous thrombosis at other sites |
up to 28 days | |
Secondary | Ventilator-free days | defined as the number of days up to Day 28 following arrival at the trauma bay/ED on which a patient breathed without assistance (if period of unassisted breathing lasted at least 48 consecutive hours). Patients who die during study follow-up or require 28 or more days of mechanical ventilation will be assigned zero ventilator-free days | From arrival to day 28 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01912547 -
Thromboelastography During Surgery for Malignant Pleural Mesothelioma
|
Phase 0 | |
Completed |
NCT03674684 -
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
|
||
Recruiting |
NCT05874843 -
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
|
N/A | |
Withdrawn |
NCT04705701 -
Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care
|
N/A | |
Not yet recruiting |
NCT04515420 -
The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
|
||
Completed |
NCT01598831 -
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
|
Phase 3 | |
Completed |
NCT04580563 -
Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study
|
N/A | |
Withdrawn |
NCT04274699 -
Clinical Evaluation of the Hemosonics Quantra® Coagulation Monitor in Liver and Multivisceral Transplantation
|
||
Terminated |
NCT02540434 -
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
|
N/A | |
Completed |
NCT02203968 -
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
|
Phase 1/Phase 2 | |
Unknown status |
NCT01854476 -
Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze
|
Phase 2/Phase 3 | |
Completed |
NCT00816127 -
Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
|
N/A | |
Active, not recruiting |
NCT02926274 -
Transfusion Using Stored Whole Blood
|
N/A | |
Completed |
NCT05295693 -
Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study
|
||
Not yet recruiting |
NCT04582188 -
The Early Coagulopathy for the Prognosis in Sepsis
|
||
Recruiting |
NCT04528888 -
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection
|
Phase 3 | |
Recruiting |
NCT05449834 -
Fibrinogen Early In Severe Trauma StudY II
|
Phase 3 | |
Withdrawn |
NCT04435015 -
The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04115722 -
Coagulation Parameters in IBD Patients
|
||
Completed |
NCT01228058 -
A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
|
N/A |