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Coagulation Factor Replacement
Frozen Plasma + Clotting Factors for Traumatic Hemorrhage (FiiRST-2 Trial)
Phase 4
Recruiting
Led By Luis T Da Luz, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial will help improve care for trauma patients by providing data on the safety and efficacy of two potential treatments for acute trauma coagulopathy.
Who is the study for?
This trial is for adults over 16 who've suffered severe trauma, have triggered a massive hemorrhage protocol within the first hour at the hospital, and haven't received more than 2 units of red blood cells. It's not for those pregnant, refusing blood transfusions, with certain past medical conditions or on anticoagulants recently.
What is being tested?
The study tests early use of Fibrinogen Concentrate (FC) and Prothrombin Complex Concentrate (PCC) in severely injured patients at risk of massive bleeding. It compares these European standards against North American ones to see if they lead to better outcomes and are safe as first-line treatments.
What are the potential side effects?
While specific side effects aren't listed here, FC and PCC could potentially cause reactions related to clotting such as thrombosis or allergic responses due to protein content. The trial will collect safety data regarding their early administration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite of total number of Allogeneic Blood Products (ABPs)
Secondary study objectives
Incidence of thromboembolic events
Total number of RBC units
Ventilator-free days
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group- Clotting Factor ConcentratesExperimental Treatment1 Intervention
Fibryga + Octaplex (Fibrinogen + PCC)
Fibrinogen Concentrate 4g (Fibryga) + Prothrombin Complex Concentrate 2000 IU (Octaplex) in the first and second massive hemorrhage protocol (MHP) packs.
Group II: Control Group: Standard FP transfusionActive Control1 Intervention
Frozen Plasma (FP)
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
502,988 Total Patients Enrolled
OctapharmaIndustry Sponsor
85 Previous Clinical Trials
10,907 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,723 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are older than 16 years.You do not want to receive a blood transfusion for religious or personal reasons.You have had a condition called heparin induced thrombocytopenia (HIT) in the past.You have a severe head injury with a very low score on the Glasgow Coma Scale.You have been using blood thinners in the past 7 days.Showing signs of mental health problems within the first hour of arriving at the hospital's trauma bay or emergency department.Your injury happened more than 3 hours ago.You have received more than 2 units of red blood cells before arriving at the hospital.You have received more than 2 units of red blood cells before the emergency team took special actions.You have a known condition that makes it hard for your blood to clot.People who have had severe injuries from accidents or violence.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group: Standard FP transfusion
- Group 2: Intervention Group- Clotting Factor Concentrates
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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