Clinical Trial

Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery

Completed
View on ClinicalTrials.gov →
Summary
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery. The study compares this investigational product with an existing hemostatic agent to assess whether it performs equally well in controlling surgical bleeding. Patients with spinal stenosis, tumors, or trauma who require spinal surgery will be enrolled. The hemostat will be applied intraoperatively when grade 3 bleeding is observed. The study aims to determine how well the product works in achieving hemostasis and its safety when it is used during surgery.
Trial Details
NCT Number NCT07354178
Lead Sponsor DALIM TISSEN Co., Ltd.
Conditions Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis, Spinal Surgery, Intraoperative Bleeding
Enrollment 130 participants
Start Date 2024-10-22
Primary Completion 2025-06-19 (estimated)
Study Completion 2025-08-18 (estimated)
Updated on ClinicalTrials.gov 2026-01-21