Status:
COMPLETED
Combined IV and Topical TXA in Major Spine Surgery
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Spine Surgery
Back Pain
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
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 wil...
Detailed Description
Prospective triple-blinded randomized control trial. The surgeon will provide study information (protocol, consent, general information) to patients in the surgeon's office. Recruitment will be done t...
Eligibility Criteria
Inclusion
- Adults 18-80 years old
- Undergo major multilevel spine surgery (2-8 levels)
- Male or female
Exclusion
- 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
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04797156
Start Date
March 3 2021
End Date
August 15 2024
Last Update
April 4 2025
Active Locations (1)
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1
Mount Sinai West Hospital
New York, New York, United States, 10019