Tranexamic Acid to Reduce Blood Loss in Spine Surgery
Recruiting
Phase 2
Phase 3
Interventional Study
Spinal Injuries
Spinal Deformity
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 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 252 (estimated)
- Sponsor
- Columbia University · Other
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About This Trial
This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements.
The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enroll…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
2. Surgical fixation to be performed within 21 days of injury
3. Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions
Exclusion Criteria:
1.…
Contacts