Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery (NCT07354178) | Clinical Trial Compass
CompletedNot Applicable
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
South Korea130 participantsStarted 2024-10-22
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. An individual who has voluntarily signed the written consent form for participating in the research as a trial subject
✓. Patients aged 20 or older
✓. Patients who are able to participate throughout the entire clinical trial period
✓. Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc.
✓. Patients for whom hemostasis is difficult to achieve using standard procedures
✓. Patients with grade 3 or higher bleeding \* Grade 4 or 5 bleeding is reduced to grade 3 by normal procedures (compression, sutures, electrosurgical scalpel, etc.).
Exclusion criteria
✕. Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat
✕. Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials
✕. Individuals deemed inappropriate for participation by the investigators
What they're measuring
1
Hemostasis success rate
Timeframe: Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes