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Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 1, 2025 to Dec 1, 2026
    • Study completion date: Jan 1, 2026 to Jan 1, 2027
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Study completion date: Jan 1, 2024 to Jan 1, 2026
    v7
  4. Primary completion date: Sep 1, 2022 to Dec 1, 2023
    • Study completion date: Jan 1, 2023 to Jan 1, 2024
    v6
  5. Start date changed from estimate of Dec 1, 2021 to Aug 26, 2019v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Sep 1, 2021 to Dec 1, 2021v4
  2. Primary completion date: Jan 2020 to Sep 1, 2022
    • Start date: Mar 1, 2019 to Sep 1, 2021
    • Study completion date: Jan 2020 to Jan 1, 2023
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2019 to Mar 1, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.
Trial Details
NCT Number NCT03849443
Lead Sponsor Rush University Medical Center
Conditions
(from sponsor)		 Open Posterior Thoracolumbar Spinal Fusion Procedure
Enrollment 604 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov