Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT04244981
PHASE4

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

Sponsor: SHI Jia

View on ClinicalTrials.gov

Summary

This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest tube drainage from 1 hour after trial drug administration to 24 hours after surgery in patients undergoing valvular heart surgery.

Official title: Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery, Compared With Fresh Frozen Plasma: Study Protocol for a Non-inferiority, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

476

Start Date

2023-10-25

Completion Date

2025-04-09

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Prothrombin Complex Concentrate, Human

Cross-Reference to FFP group.

DRUG

Fresh Frozen Plasma

All patients have valve surgery via median sternotomy with general anaesthesia and CPB. Mild hypothermia (32-34 ℃) is maintained during bypass, with patients thereafter being rewarmed to a nasopharyngeal temperature of 37.0 ℃ and a rectal temperature of 35.5 ℃. Heparin (400 IU/kg) is given before initiation of CPB, and ACT is maintained above 480 seconds. Tranexamic acid is administered as a 20-mg/kg bolus within the first hour, followed by an infusion of 2 mg/kg per hour infusion until the end of surgery. After CPB, heparin is neutralised with protamine sulphate (1 mg per 100 IU heparin), targeting an ACT within ±10% of the baseline value; an additional 20-30 mg is given if ACT remains elevated. FFP or PCC, per randomization, is given once post-CPB coagulation factor deficiency is confirmed.

Locations (2)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China