Phase 2
N=61
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
Curvature of Spine
Bottom Line
View on ClinicalTrials.gov: NCT01728636 ↗Enrolled (actual)
61
Serious AEs
29.5%
Results posted
Jan 2021
Primary outcome: Primary: Total Red Blood Cells Transfused in the Intraoperative Period — 1140; 1460 milliliters — p=.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Red Blood Cells Transfused in the Intraoperative Period |
1140; 1460 | .05 |
| SECONDARY Additional Blood Products Transfused |
1; 2 | — |
| SECONDARY Post Operative Major Morbidity |
9; 9 | — |
Summary
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
Eligibility Criteria
Inclusion Criteria
- age>17 years
- undergoing posterior spine fusion surgery for kyphoscoliosis with a >80% chance of major transfusion
Exclusion Criteria
- age < 18 years
- non-English speaking
- pregnancy
- emergency procedures
- surgery for tumor, trauma or infection
- severe coronary artery disease
- history of venous thromboembolism
- history of cerebral vascular accident
- history of renal insufficiency
- allergy to tranexamic acid
Data sourced from ClinicalTrials.gov (NCT01728636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.