Collagen-thrombin Matrix Efficacy During Cardiac Surgery: a Prospective Randomized Controlled Trial

Summary

In this prospective open-label randomized trial, 160 patients with elective off-pump coronary artery bypass (OPCAB) surgery were enrolled. After primary suture of aortocoronary anastomosis, if an area of hemorrhage was identified, patients were randomized to receive Floseal® or Collastat® (n=80), respectively. The selected agent was applied with compression of the target area for 1 min. If hemostasis was not achieved, the agent was re-applied for a further 1 min, and was repeated up to 5 min, after which rescue treatment was applied, including any conventional surgical methods.

Timeline

Start

2018-02-05

Primary completion

2020-03-17

Completion

2020-03-31

Publications

• Background Lee H, Lee JH, Jeon CS, Ko JH, Park SN, Lee YT. Evaluation of a novel collagen hemostatic matrix in a porcine heart and cardiac vessel injury model. J Thorac Dis. 2019 Jul;11(7):2722-2729. doi: 10.21037/jtd.2019.06.59.
• Kim HH, Lee KJ, Kang DR, Lee JH, Youn YN. Hemostatic efficacy of a flowable collagen-thrombin matrix during coronary artery bypass grafting: a double-blind randomized controlled trial. J Cardiothorac Surg. 2023 Jun 15;18(1):193. doi: 10.1186/s13019-023-02196-3.

Drugs

Indications