Bleeding Cardiac Surgery PatientsPhase 3FARES-2NCT05523297
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
A Phase 3 study testing Octaplex and Frozen Plasma Product, Human in people with Bleeding Cardiac Surgery Patients, run by Octapharma at 13 sites in 2 countries.
Trial summary
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding Cardiac Surgery Patients
- What is being tested?
- Octaplex and Frozen Plasma Product, Human
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 30 Nov 2022to 27 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
- Coagulation factor replacement with PCC or FP ordered in the operating room for:
- Management of bleeding, or
- Anticipated bleeding in a patient who has been on-pump for >2 hours or has undergone a complex procedure (e.g., aortocoronary bypass [ACB] plus aortic valve replacement)
- Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time [CT] or INR) or suspected based on the clinical situation
- Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.
Who cannot join
- Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump [IABP]) or repair of thoracoabdominal aneurysm
- Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
- Severe right heart failure (clinical diagnosis ± echocardiography)
- Known contraindications to heparin
- PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
- Known thromboembolic event (TEE) within 3 months prior to surgery
Show all 11Show fewer
- History of severe allergic reactions to PCC or FP
- Individuals who have immunoglobulin A (IgA) deficiency with known antibodies against IgA
- Refusal of allogeneic blood products
- Known pregnancy
- Currently enrolled in other interventional clinical trials
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Canada11 sites
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 8E7
Kingston General Hospital
Kingston, Ontario, K7L 2V7
London Health Sciences
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Quebec Laval
Québec, Quebec, G1V 4G5
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
University of British Columbia and Vancouver Coastal Health Authority
Vancouver, British Columbia, V5Z 1M9
United States2 sites
Duke University Health System
Durham, North Carolina, 27710
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Prospective, Multicenter, Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Bleeding Adult Cardiac Surgical Patients
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Read the detailed description
Patients were randomized to receive either 4-factor PCC (Octaplex) or frozen plasma (FP). The study compared the hemostatic treatment response to Octaplex versus FP, defined as effective if no additional systemic or surgical hemostatic intervention is required from 60 minutes to 24 hours after initiation of the first treatment dose. The study includes adult (≥18 years old) patients who underwent cardiac surgery with cardiopulmonary bypass (CPB) and required coagulation factor replacement due to bleeding post-CPB and after adequate reversal of heparin with protamine (as assessed by the surgical staff based on clinical and laboratory criteria) during surgery, and who have a known (e.g., as indicated by INR) or suspected coagulation factor deficiency.
- Conditions
- Bleeding Cardiac Surgery Patients
- Being tested
- Octaplex, Frozen Plasma Product, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctaplexDrug
Prothrombin complex concentrate
Frozen Plasma Product, HumanDrug
If additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma
| Study group | Role | What they receive |
|---|---|---|
| Octaplex | Experimental | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg).
Octaplex: Prothrombin complex concentrate Receives: Drug: Octaplex |
| Frozen plasma | Active comparator | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg).
Frozen Plasma Product, Human Receives: Drug: Frozen Plasma Product, Human |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Additional Hemostatic Intervention
Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII [rFVIIa], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.
Measured: 60 minutes to 24 hours after first dose of IMP
Secondary outcomes (28)
Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels
Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by <30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP.
Measured: 60 minutes to 24 hours after first dose of IMP
Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups.
Measured: 12 and 24 hours after chest closure
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB).
Yes or no refers to whether severe to massive bleeding was present.
Measured: 24 hours after surgery start, after the end of CPB and after IMP initiation
Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups.
Measured: First 24 hours after the end of CPB
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups.
Measured: First 24 hours after the end of CPB
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Measured: First 24 hours and 7 days after IMP initiation
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Measured: 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Measured: 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups
Measured: 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups
Measured: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups
Measured: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups
Measured: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration.
The international normalized ratio (INR) is a standardized measure of prothrombin time (PT), ensuring consistency in results across different laboratories. The normal range for INR is around 0.8 to 1.2. Higher INR values indicate a slower clotting time and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the INR.
INR reduction was considered successful if the magnitude of the reduction was >1.0 or the post-treatment level dropped below 1.5 (INR >1.5 indicates that one or more coagulation factor levels are below the 30% critical threshold)
Measured: Within 30 minutes before to 60 minutes after the initiation of IMP administration.
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT)
The prothrombin time (PT) measures the time it takes for clotting to occur, primarily assessing the extrinsic pathway of the coagulation cascade. Normal PT values range from 9 to 13 seconds. Higher PT values indicate a prolonged clotting time, suggesting potential issues with clotting factors such as fibrinogen, factors V, VII, and X and prothrombin, and are associated with bleeding. Effective procoagulant therapy can reduce/normalize the PT.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT)
Activated partial thromboplastin time (aPTT) is a standard laboratory test that measures how long it takes (in seconds) for clotting to occur (in the presence of an activator). It evaluates the intrinsic and common pathways of the coagulation cascade, assessing factors such as VIII, IX, XI, and XII, as well as fibrinogen. Prolonged aPTT may signify deficiencies in these clotting factors and is associated with bleeding. Effective procoagulant therapy can shorten/normalize the aPTT.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT
A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with clotting time (CT) providing a measure (in seconds) of how quickly a clot starts forming. Prolonged EXTEM CT is associated with bleeding. Effective procoagulant therapy can reduce/normalize the EXTEM CT.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF
A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the EXTEM test is activated with tissue factor and evaluates the extrinsic coagulation pathway, with maximum clot firmness (MCF) providing a measure (in mm) of the strength of the clot. Reduced EXTEM MCF is associated with bleeding. Effective procoagulant therapy can increase/normalize the EXTEM MCF.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF
A rotational thromboelastometry (ROTEM; Werfen) device can be used at the bedside to rapidly assess the patient's coagulation status. Different viscoelastic tests can be performed to assess the dynamics of clot formation and lysis. Specifically, the FIBTEM test evaluates fibrin-based clotting - it is extrinsically activated with tissue factor and additionally incorporates an inhibitor to eliminate the contribution of platelets to clotting. Maximum clot firmness (MCF) in the FIBTEM test provides a measure (in mm) of the strength of the fibrin-based clot. Reduced FIBTEM MCF is associated with bleeding. Effective procoagulant therapy to restore fibrinogen can increase/normalize the FIBTEM MCF.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks
The Plateletworks device (Helena Laboratories) enables rapid bedside screening of platelet function. The system uses an impedance cell counter and Plateletworks reagent tubes to evaluate platelet function and monitor treatment effects. By comparing a baseline total platelet count against the platelet count measured in the presence of an agonist used to stimulate platelet aggregation (ADP, collagen, or arachidonic acid), the tests determine the percent aggregation or inhibition of functional platelets. Manufacturer reference ranges, determined by testing blood samples from healthy volunteers, are 86-100% for ADP, 70-100% for collagen, and 60-100% for arachidonic acid. Values within these ranges indicate 'normal (positive)' platelet aggregation, which is important for clotting; lower values may be considered 'abnormal (negative)' and reflective of platelet inhibition. The manufacturer advises each laboratory to establish their own reference ranges for their patient population.
Measured: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups.
Measured: From initiation of IMP to arrival at ICU room (within 24 hours)
Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups
Measured: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups
Measured: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of ICU Stay Between Octaplex and FP Groups
Measured: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of Hospitalization Between Octaplex and FP Groups
Measured: From the beginning of surgery up to postoperative day 30
Comparison of the Incidence of Death Between Octaplex and FP Groups
Measured: Up to 30 days after the end of CPB
Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups
Measured: From the beginning of surgery up to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start30 Nov 2022
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bleeding Cardiac Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523297
- Sponsor's protocol ID
- LEX-211
- Acronym
- FARES-2
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2022
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanaka KA, Butt AL, Stewart KE, Pezeshki G, Werner S, Bartoszko J, Ghadimi K, Solomon C, Vandyck K, Levy JH, Callum JL, Knaub S, Hegener O, Karkouti K. The association of estimated citrate load with frozen plasma versus four-factor prothrombin complex concentrate for coagulopathy after cardiac surgery: a post hoc exploratory analysis of the FARES-II randomised controlled trial. BJA Open. 2026 Jun 29;19:100577. doi: 10.1016/j.bjao.2026.100577. eCollection 2026 Sep.
PubMed 42404094Karkouti K, Callum JL, Bartoszko J, Tanaka KA, Knaub S, Brar S, Ghadimi K, Rochon A, Mullane D, Couture EJ, Lin Y, Harle C, Zeller M, Tran DTT, Solomon C, Rao V, Law M, Butt AL, Chen EP, Martins MR, Saha T, Shih AW, Vezina MC, Moussa F, Pereira Cezar Zamper R, Syed S, Buyukdere H, Werner S, Grewal D, Wong D, Vandyck KB, Tanzola R, Hughes B, Royer O, Wong S, Levy JH; FARES-II Study Group. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. 2025 May 27;333(20):1781-1792. doi: 10.1001/jama.2025.3501.
PubMed 40156829Karkouti K, Callum J, Bartoszko J, Solomon C, Knaub S, Levy JH, Tanaka KA; FARES-II Study Group. Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial. BMJ Open. 2024 Aug 21;14(8):e091381. doi: 10.1136/bmjopen-2024-091381.
PubMed 39174056
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Bleeding Adult Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT05523297
- Acronym / sponsor ID
- FARES-2 / LEX-211
- Conditions
- Bleeding Cardiac Surgery Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
Detailed description
Patients were randomized to receive either 4-factor PCC (Octaplex) or frozen plasma (FP). The study compared the hemostatic treatment response to Octaplex versus FP, defined as effective if no additional systemic or surgical hemostatic intervention is required from 60 minutes to 24 hours after initiation of the first treatment dose. The study includes adult (≥18 years old) patients who underwent cardiac surgery with cardiopulmonary bypass (CPB) and required coagulation factor replacement due to bleeding post-CPB and after adequate reversal of heparin with protamine (as assessed by the surgical staff based on clinical and laboratory criteria) during surgery, and who have a known (e.g., as indicated by INR) or suspected coagulation factor deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaplex | Experimental | Drug: OctaplexParticipants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if >60 kg). Octaplex: Prothrombin complex concentrate |
| Frozen plasma | Active comparator | Drug: Frozen Plasma Product, HumanParticipants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if >60 kg). Frozen Plasma Product, Human |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (≥18 years old) patients undergoing any index cardiac surgery employing CPB
- Coagulation factor replacement with PCC or FP ordered in the operating room for:
- Coagulation factor deficiency, either known to exist (e.g., as indicated by elevated EXTEM clotting time [CT] or INR) or suspected based on the clinical situation
- Patients who have given written informed consent. In United States patients will provide informed consent prior to surgery. In Canada, informed consent will be obtained after surgery, in accordance with Article 3.7A of the 2018 Tri- Council Policy Statement on the Ethical Conduct for Research Involving Humans.
Key exclusion criteria (11 listed)
- Undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump [IABP]) or repair of thoracoabdominal aneurysm
- Critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery)
- Severe right heart failure (clinical diagnosis ± echocardiography)
- Known contraindications to heparin
- PCC required for reversal of warfarin or direct oral anticoagulant (DOAC; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OctaplexProthrombin complex concentrate | Drug | Octaplex |
| Frozen Plasma Product, HumanIf additional treatment is required after the maximum dose of IMP is administered or the treatment period has elapsed, patients in both groups will receive frozen plasma | Drug | Frozen plasma |
Primary outcome
Number of Patients Requiring Additional Hemostatic Intervention
Time frame: 60 minutes to 24 hours after first dose of IMP
Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII [rFVIIa], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP.
28 secondary outcomes
Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels
Time frame: 60 minutes to 24 hours after first dose of IMP
Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups.
Time frame: 12 and 24 hours after chest closure
Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB).
Time frame: 24 hours after surgery start, after the end of CPB and after IMP initiation
Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups.
Time frame: First 24 hours after the end of CPB
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups.
Time frame: First 24 hours after the end of CPB
Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Time frame: First 24 hours and 7 days after IMP initiation
Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Time frame: 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation
Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups.
Time frame: 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation
Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups
Time frame: 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Intracerebral Hemorrhage Between the Octaplex and FP Groups
Time frame: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Gastrointestinal Hemorrhage Between Octaplex and FP Groups
Time frame: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Compare Incidence of Surgical Re-exploration Between Octaplex and FP Groups
Time frame: 24 hours after start of surgery, after the end of CPB and after IMP initiation
Comparison of the Effect of Octaplex Versus FP Administration on the Change in International Normalised Ratio (INR) Before and After Therapy Administration.
Time frame: Within 30 minutes before to 60 minutes after the initiation of IMP administration.
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Prothrombin Time (PT)
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Activated Partial Thromboplastin Time (aPTT)
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Fibrinogen Activity
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM CT
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM EXTEM MCF
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in ROTEM FIBTEM MCF
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Count Measured by Plateletworks
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of the Effect of Octaplex Versus FP Administration on the Change in Platelet Function Measured by Plateletworks
Time frame: Within 75 minutes before to within 75 minutes after the initiation of IMP administration
Comparison of Total Time Elapsed From Initiation of the First Dose of IMP to Arrival Into the ICU Between the Octaplex and FP Groups.
Time frame: From initiation of IMP to arrival at ICU room (within 24 hours)
Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups
Time frame: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of Mechanical Ventilation Between Octaplex and FP Groups
Time frame: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of ICU Stay Between Octaplex and FP Groups
Time frame: From the beginning of surgery up to postoperative day 30
Comparison of the Duration of Hospitalization Between Octaplex and FP Groups
Time frame: From the beginning of surgery up to postoperative day 30
Comparison of the Incidence of Death Between Octaplex and FP Groups
Time frame: Up to 30 days after the end of CPB
Comparison of the Number of Days Alive and Out of Hospital Between Octaplex and FP Groups
Time frame: From the beginning of surgery up to postoperative day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42404094Tanaka KA, Butt AL, Stewart KE, Pezeshki G, Werner S, Bartoszko J, Ghadimi K, Solomon C, Vandyck K, Levy JH, Callum JL, Knaub S, Hegener O, Karkouti K. The association of estimated citrate load with frozen plasma versus four-factor prothrombin complex concentrate for coagulopathy after cardiac surgery: a post hoc exploratory analysis of the FARES-II randomised controlled trial. BJA Open. 2026 Jun 29;19:100577. doi: 10.1016/j.bjao.2026.100577. eCollection 2026 Sep.
- Derived from this study: PubMed 40156829Karkouti K, Callum JL, Bartoszko J, Tanaka KA, Knaub S, Brar S, Ghadimi K, Rochon A, Mullane D, Couture EJ, Lin Y, Harle C, Zeller M, Tran DTT, Solomon C, Rao V, Law M, Butt AL, Chen EP, Martins MR, Saha T, Shih AW, Vezina MC, Moussa F, Pereira Cezar Zamper R, Syed S, Buyukdere H, Werner S, Grewal D, Wong D, Vandyck KB, Tanzola R, Hughes B, Royer O, Wong S, Levy JH; FARES-II Study Group. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. 2025 May 27;333(20):1781-1792. doi: 10.1001/jama.2025.3501.
- Derived from this study: PubMed 39174056Karkouti K, Callum J, Bartoszko J, Solomon C, Knaub S, Levy JH, Tanaka KA; FARES-II Study Group. Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial. BMJ Open. 2024 Aug 21;14(8):e091381. doi: 10.1136/bmjopen-2024-091381.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octaplex and Frozen Plasma Product, Human in people with Bleeding Cardiac Surgery Patients, run by Octapharma at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Requiring Additional Hemostatic Intervention (time frame: 60 minutes to 24 hours after first dose of IMP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05523297, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.