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.

Timeline

Start

2023-10-25

Primary completion

2025-03-11

Completion

2025-04-09

Outcome

Outcome not reported

Stopped: “At a meeting on February 17, 2025, the Data and Safety Monitoring Board recommended early termination because the predefined efficacy boundary was crossed.”

Publications

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• Pei L, Sun C, Lv H, Zhang Y, Shi J. Efficacy of prothrombin complex concentrate (PCC) versus fresh frozen plasma (FFP) in reducing perioperative blood loss in cardiac surgery: study protocol for a non-inferiority, randomised controlled trial. BMJ Open. 2022 Feb 10;12(2):e051072. doi: 10.1136/bmjopen-2021-051072.

Drugs

Indications