At a glance
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Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery
In Brief
A Phase 4 clinical trial evaluating Tranexamic Acid and Placebo for Lumbar Spinal Stenosis and Thoracic Spinal Stenosis. Completed, enrolled 29 participants across 1 site.
Detailed Summary
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Study Details
Timeline
Interventions
A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
A single topical application of matching placebo, which is 100 mL of normal saline.