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Phase 2 Completed N=61 Randomized Quadruple-blind Treatment

The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery

Curvature of Spine
Source: ClinicalTrials.gov NCT01728636 ↗
Enrolled (actual)
61
Serious AEs
29.5%
Results posted
Jan 2021
Primary outcomePrimary: Total Red Blood Cells Transfused in the Intraoperative Period — 1140; 1460 milliliters — p=.05

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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