Actively Recruiting
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
Led by SHI Jia · Updated on 2025-10-27
820
Participants Needed
2
Research Sites
105 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
This study is a non-inferiority, randomized controlled trial, based on the hypothesis that 4-factor PCC is not inferior to FFP in reducing perioperative blood loss in patients undergoing cardiac surgery under cardiopulmonary bypass. 816 subjects will be randomly divided into 2 groups (group PCC and group FFP), with 408 cases in each group. Patients will be given 8\~15 IU/kg 4-factor PCC in group PCC and 6\~10 ml/kg FFP in group FFP. All the patients will be followed up respectively at 24 hours, 48 hours, 72 hours and 7 days after the surgery. The primary outcome is the volume of blood loss within 24 hours after surgery. The secondary outcomes include (1) the total units of allogeneic red blood cells (RBCs) transfused within 7 days after surgery and (2) hemostatic response (effective if no hemostatic interventions occurred from 60 minutes to 24 hours after treatment initiation). Adverse events and serious adverse events will be monitored as safety outcomes.
CONDITIONS
Official Title
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
Who Can Participate
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
- Signed informed consent form
- Developing coagulation factor deficiency or coagulopathic bleeding during surgery, indicated by prolonged activated partial thromboplastin time (> 45 seconds) measured 20 minutes after bypass or excessive bleeding observed
You will not qualify if you...
- History of cardiac surgery
- Severe liver dysfunction before surgery
- Coagulopathy before surgery, including inherited or acquired coagulation factor deficiencies, thrombocytopenia, platelet dysfunction, or other bleeding disorders
- Use of warfarin with INR greater than 1.2 before surgery
- Clopidogrel stopped less than 5 days before surgery or low molecular weight heparin stopped less than 12 hours before surgery
- Allergy to allogeneic blood products
- Pregnancy
- Other serious diseases affecting survival, such as cancers
AI-Screening
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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
Research Team
S
Shi Jia, M.D.
CONTACT
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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