Multivariate predictors of blood product use in cardiac surgery.
K Gage Parr, Minalkumar A Patel, Rene Dekker...
https://pubmed.ncbi.nlm.nih.gov/12698398Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID04244981
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery Compared With Fresh Frozen Plasma Non-inferiority Randomized Controlled Trial
Led by SHI Jia · Updated on 2025-10-27
820
Participants Needed
2
Research Sites
33 weeks
Total Duration
On this page
Sponsors
S
SHI Jia
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two treatments, 4-factor prothrombin complex concentrate (PCC) and fresh frozen plasma (FFP), to see if PCC is not worse than FFP in reducing blood loss during cardiac surgery with cardiopulmonary bypass. The study involves 816 adult patients aged 18 to 80 years undergoing elective coronary artery bypass grafting, valve replacement, or valvuloplasty. The goal is to improve coagulation management and reduce complications, transfusions, and costs related to blood loss during surgery. Patients with prolonged activated partial thromboplastin time (APTT) or excessive bleeding after cardiopulmonary bypass will receive either 8–15 IU/kg of PCC or 6–10 mL/kg of FFP according to their group assignment. The study is randomized and controlled, with standardized preoperative care and surgical techniques. Both groups will be monitored closely during and after surgery with follow-ups at 24, 48, and 72 hours, and 7 days post-surgery. Participants will undergo laboratory tests including hemoglobin, hematocrit, platelet count, INR, PT, APTT, fibrinogen levels, and blood biochemistry. Researchers will measure blood loss volume within 24 hours after surgery as the primary outcome. Secondary outcomes include red blood cell transfusions within 7 days and hemostatic response from 60 minutes to 24 hours after treatment start. Safety will be monitored by tracking adverse events throughout the study period lasting up to 7 days after surgery.
CONDITIONS
Brief Title
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Undergoing elective coronary artery bypass grafting (CABG) or valve replacement or valvuloplasty with cardiopulmonary bypass
- Signing informed consent
- Developing coagulation factor deficiency or coagulopathic bleeding during surgery indicated by prolonged APTT (> 45 seconds) or excessive bleeding
You will not qualify if you...
- History of prior cardiac surgery
- Severe liver dysfunction before surgery
- Preexisting coagulopathy including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction, or other bleeding disorders
- Use of warfarin with INR > 1.2 before surgery
- Withdrawal of clopidogrel less than 5 days or low molecular weight heparin less than 12 hours before surgery
- Allergy to allogeneic blood products
- Pregnancy
- Other serious diseases that may affect survival, such as cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Surgery day and immediate perioperative period
Participants undergo cardiac surgery and receive either prothrombin complex concentrate or fresh frozen plasma if coagulation issues or excessive bleeding occur during surgery.
1 surgery and treatment visit
Post-operative Follow-up
Duration - 7 days after surgery
Participants are monitored for blood loss, transfusion needs, and hemostatic response for 7 days after surgery with laboratory tests and safety assessments.
4 follow-up visits at 24, 48, 72 hours, and 7 days after surgery
Trial Site Locations
Total: 2 locations
1
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
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Research Team
S
Shi Jia, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Andrej Alfirevic, Meng Xu, Douglas Johnston...
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M Sellman, M A Intonti, T Ivert
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G Ottino, R De Paulis, S Pansini...
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A Zacharias, R H Habib
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Matthew Dean Linden
https://pubmed.ncbi.nlm.nih.gov/15087599Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline.
Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Victor A Ferraris, Suellen P Ferraris...
https://pubmed.ncbi.nlm.nih.gov/17462454Reexploration for hemorrhage following coronary artery bypass grafting: incidence and risk factors. Northern New England Cardiovascular Disease Study Group.
L J Dacey, J J Munoz, Y R Baribeau...
https://pubmed.ncbi.nlm.nih.gov/9565127