Tranexamic Acid in Adult Spinal Deformity Surgery
Recruiting
Phase 3
Interventional Study
Spinal Deformity
Degenerative Lumbar Spinal Stenosis
Blood Loss, Surgical
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Other
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About This Trial
Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical speci…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18-80
* Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
* \+ fusion to pelvis
Exclusion Criteria:
* Surgical factors:
* Anterior Approach
* Presence or history of dural tear without r…
Contacts