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

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective open-label randomized trial, 80 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=40), 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Hemostatics; Thrombin

Criteria

Inclusion Criteria:

1. patients aged 19 years or older

2. undergoing elective OPCAB surgery with multi-vessel coronary artery disease.

Exclusion Criteria:

1. patients were pregnant

2. had a known sensitivity to any components of the bovine thrombin preparations or the porcine origin materials.