Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery

PHASE4RecruitingINTERVENTIONAL
Enrollment

796

Participants

Timeline

Start Date

October 25, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Cardiac Surgical Procedures
Interventions
DRUG

Prothrombin Complex Concentrate, Human

A 4-factor prothrombin complex concentrate (Confidex®, CSL Behring, Marburg, Germany), containing a defined concentration of the four vitamin K-dependent clotting factors (II, VII, IX and X) and the thrombo-inhibitor proteins C and S. Each vial of Confidex® contains a relatively high concentration of coagulation factor II (20-48 IU/mL), factor VII (10-25 IU/mL), factor IX (20-31 IU/mL), factor X (22-60 IU/mL), proteins C (15-45 IU/mL), proteins S (13-38 IU/mL), Heparin (0.5 IU/mL), and antithrombin (0.6 IU/mL). When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 8~15 IU/kg PCC.

DRUG

Fresh Frozen Plasma

When APTT is prolonged (\> 45 s) measured 20 minutes after CPB or excessive bleeding observed, patients will be given 6~10 mL/kg FFP.

Trial Locations (2)

100037

RECRUITING

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC, Beijing

100730

RECRUITING

Peking Union Medical College Hospital, Beijing

All Listed Sponsors
collaborator

Peking Union Medical College Hospital

OTHER

collaborator

Beijing Anzhen Hospital

OTHER

collaborator

Guizhou Provincial People's Hospital

OTHER

collaborator

Zunyi Medical College

OTHER

lead

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER