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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
FiiRST-2 Trial 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.Check my eligibility
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.See study design
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.
FiiRST-2 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of total number of Allogeneic Blood Products (ABPs)
Secondary outcome measures
Incidence of thromboembolic events
Total number of RBC units
Ventilator-free days
FiiRST-2 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)
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,169 Total Patients Enrolled
OctapharmaIndustry Sponsor
84 Previous Clinical Trials
7,508 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,341 Previous Clinical Trials
26,452,363 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.
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this ever been attempted before?
"Presently, there are 19 concurrent trials for Fibrinogen + PCC being run in 44 urban areas and 13 distinct nations. The first investigation of the drug began in 2018, when PRA Health Sciences ran a Phase 3 study with 200 people's participation to gain approval. Since then, 163 additional tests have been conducted."
Answered by AI
Are there any recruitment openings for this experiment?
"Affirmative. Information on clinicaltrials.gov indicates that this trial, which was originally posted April 1st 2021 is currently looking for participants. 350 individuals need to be sourced from 4 distinct centres."
Answered by AI
Has the FDA authorized Fibrinogen + PCC for general medical usage?
"Data suggests that Fibrinogen + PCC is approved and thus scores a 3 on our team's safety scale."
Answered by AI
What medical cases usually necessitate a prescription of Fibrinogen + PCC?
"Fibrinogen + PCC is the go-to treatment for factor x deficiency and has shown to be effective in preventing perioperative bleeding due to this condition, as well as treating hemorrhage and tissue adhesions."
Answered by AI
What is the target number of participants for this clinical trial?
"Affirmative. Clinicaltrials.gov details that this clinical research is currently recruiting participants, having been initially posted on April 1st 2021 and updated as recently as October 4th 2021. 350 patients are needed at four separate sites of study."
Answered by AI
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