Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
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. 560 subjects will be randomly
divided into 2 groups (group PCC and group FFP), with 280 cases in each group. Patients will
be given a 4-factor PCC based on the patients' body weight and INR in group PCC and a dose of
10-15 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 during and within 24 hours after surgery. The secondary outcomes include (1) the total
units of allogeneic red blood cells (RBCs) transfused during and within 7 days after surgery
and (2) re-exploration due to postoperative bleeding within 7 days after surgery.
Phase:
Phase 4
Details
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital