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Prothrombin Complex Concentrate
Prothrombin Complex vs Frozen Plasma for Bleeding (FARES-2 Trial)
Phase 3
Recruiting
Research Sponsored by Octapharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes before to within 60 minutes after the initiation of imp administration.
Awards & highlights
FARES-2 Trial Summary
This trial will compare the safety and efficacy of two products in adult cardiac surgery patients.
Who is the study for?
Adults (18+) undergoing cardiac surgery with CPB who need coagulation factor replacement due to bleeding or anticipated bleeding. Eligible patients must consent to the study, not be in critical condition before surgery, have no severe heart failure or known allergies to trial medications, and not be pregnant or enrolled in other trials.Check my eligibility
What is being tested?
This Phase 3 trial compares two treatments for managing bleeding during cardiac surgery: Octaplex (a prothrombin complex concentrate) and Frozen Plasma Product. About 500 patients at roughly a dozen hospitals will be randomly assigned one of these treatments.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to the products used, potential clotting issues such as thromboembolic events, and complications related to underlying conditions that affect blood coagulation.
FARES-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 minutes before to within 60 minutes after the initiation of imp administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes before to within 60 minutes after the initiation of imp administration.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interventional procedure
Secondary outcome measures
Compare efficacy in terms of the incidence of transfusion of individual allogeneic blood components transfused between the Octaplex and FP groups.
Compare efficacy in terms of the mean number of total allogeneic blood components (IMP and non-IMP) transfused between the Octaplex and FP groups.
Compare efficacy in terms of the mean number of total non-IMP allogeneic blood components transfused between the Octaplex and FP groups.
+23 moreSide effects data
From 2022 Phase 3 trial • 208 Patients • NCT0274033548%
Procedural Pain
14%
Postoperative Wound Complications
12%
Asthenia
6%
Anaemia
6%
Nervous System Disorders
5%
Cardiac AEs
5%
Musculoskeletal and connective tissue disorders
5%
Dysuria
4%
Catheter Site Related Reaction
4%
Procedural Vomiting
4%
Metabolism and nutrition disorders
3%
Abdominal Pain
3%
Hyperthermia
2%
Abdominal Distension
2%
Suture Related Complication
2%
Respiratory, thoracic and mediastinal disorders
1%
Soft Tissue Haemorrhage
1%
Myocardial Ischaemia
1%
Mesenteric Haematoma
1%
Proctitis
1%
Angina Unstable
1%
Cardiac Failure Chronic
1%
Gastritis Erosive
1%
Death
1%
Multiple Organ Dysfunction Syndrome
1%
Orchitis
1%
Anastomotic Haemmorhage
1%
Failure to Anastomose
1%
Joint Dislocation
1%
Subdural Haemorrhage
1%
Cerebral Infarction
1%
Acute Respiratory Failure
1%
Pulmonary Embolism
1%
Pulmonary Oedema
1%
Dyschezia
1%
Pneumonia
1%
Shock
1%
Pyrexia
1%
Vascular Disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Octaplex
Beriplex P/N (Kcentra)
FARES-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OctaplexExperimental Treatment1 Intervention
Each participant to receive up to 2 Octaplex infusion intravenously within first 24 hours. Exceeding 24 hours frozen plasma will be administered
Group II: Frozen plasmaActive Control1 Intervention
Each participant will be administered FP according to the local standard
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octaplex
2017
Completed Phase 3
~210
Find a Location
Who is running the clinical trial?
OctapharmaLead Sponsor
84 Previous Clinical Trials
7,358 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or cannot take heparin due to health reasons.I am 18 or older and will have heart surgery using a heart-lung machine.I have or might have a blood clotting disorder.I needed a clotting factor concentrate to reverse blood thinners before or during surgery.I have had a blood clot within the last 3 months.I have an IgA deficiency and antibodies against IgA.I am undergoing a major heart or blood vessel surgery.I received or will receive blood clotting treatment during a complex heart surgery.I have been diagnosed with severe right heart failure.I was in a life-threatening condition just before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Octaplex
- Group 2: Frozen plasma
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 Octaplex been cleared by the FDA?
"Octaplex safety is rated a 3 by our team at Power. This is because it has reached Phase 3 in clinical trials, meaning that there exists some evidence of the medication's efficacy as well as multiple rounds of data supporting its safety."
Answered by AI
Are there many facilities in operation that are conducting this research program within state borders?
"To date, this research is being conducted at 10 sites which are situated in locations such as London, Montréal and Durham. Please note that if you do decide to participate it is important to select the site nearest your location to reduce travel time commitments."
Answered by AI
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