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

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.

Conditions

• Valvular Heart Surgery

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Zunyi Medical College

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• SHI Jia

  lead OTHER

Principal Investigators

• Lijian Pei, M.D. · Peking Union Medical College Hospital

• Jia Shi, M.D. · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-25

Primary Completion

2025-03-11

Completion

2025-04-09

Countries

• China

Study Locations