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NCT02314988 · ClinicalTrials.gov registry record · Phase 2
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
A Phase 2 study of Spinal Deformity and Spinal Injuries, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 252
- Enrollment target
- 4
- Study locations
NCT02314988: Recruiting Phase 2 study of Spinal Deformity and Spinal Injuries, sponsored by Columbia University.
NCT02314988 is a Phase 2 study of Spinal Deformity and Spinal Injuries that is actively recruiting participants, run by Columbia University. The registered enrollment target is 252 participants, below the 587-participant average among 7 other Spinal Deformity trials with a reported enrollment target (57% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02314988, a Phase 2 study of Spinal Deformity and Spinal Injuries, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 252 participants
- Enrollment target
- 4
- Study locations
Study Summary
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 enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tranexamic Acid
Study Locations (4)
California
- University of California San Francisco Medical Center - San Francisco
Kentucky
- Norton Leatherman Spine Center - Louisville
New York
- NYP/The Allen Hospital - CUIMC - New York
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What NCT02314988 shows while recruiting
NCT02314988 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 587-participant average among 7 other Spinal Deformity trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Spinal Deformity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02314988 reports a single indexed study location in California, Kentucky, New York.
Frequently Asked Questions
What is clinical trial NCT02314988 about?
NCT02314988 is a clinical study titled "Tranexamic Acid to Reduce Blood Loss in Spine Surgery". 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, resear...
What is the current status of trial NCT02314988?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 252 participants. The study started on 2020-06-15. Estimated completion is 2026-07.
What conditions does trial NCT02314988 study?
This clinical trial studies the following conditions: Spinal Deformity, Spinal Injuries.
What interventions are being tested in trial NCT02314988?
The interventions under investigation include: Placebo (DRUG), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT02314988?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02314988 being conducted?
This trial has 4 study locations across California, Kentucky, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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