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.
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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

Ronald A Lehman, MD

2129325067

rl2781@cumc.columbia.edu

CONTACT

Matthew J. Cooney

mc5386@cumc.columbia.edu

CONTACT