Back Pain Clinical Trial
Official title:
The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial
This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.
Status | Recruiting |
Enrollment | 65 |
Est. completion date | December 2024 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adults 18-80 years old - Undergo major multilevel spine surgery (2-8 levels) - Male or female Exclusion Criteria: - ASA class V - Urgent or emergent surgery, - Morbid obesity - Patients with known coagulopathy disorder, hx of thromboembolic event <1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease - Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs - Religious or other belief that limit blood transfusion, - Surgery duration more than 6 hours - Patient refusal or inability to consent |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai West Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hematocrit level | The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3. | Baseline and Post-operative day 1, 2 and 3 | |
Secondary | Post-operative drain output | The amount of post-operative drain output (ml) during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. | Post-operative day 1, 2 and 3 |
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