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Tranexamic Acid in Adult Spinal Deformity Surgery

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Mar 2026 to Mar 2027v15
  2. Re-verified, no change to tracked fieldsv14
  3. Primary and study completion dates: Mar 2025 to Mar 2026v13
  4. Primary and study completion dates: Mar 2024 to Mar 2025v12
  5. Primary and study completion dates: Dec 2023 to Mar 2024v11
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since Aug 11, 2022, no change to tracked fieldsv9-v10
  2. Primary and study completion dates: May 2021 to Dec 2023v8
  3. 2 versions Re-verified since Feb 19, 2020, no change to tracked fieldsv6-v7
  4. Primary and study completion dates: May 2019 to May 2021
    • Eligibility criteria expanded, about 15 words
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2018 to Jul 11, 2018
    v3
  7. Start date: Jun 2018 to Jul 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine surgery.
Trial Details
NCT Number NCT03553186
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Spinal Deformity, Degenerative Lumbar Spinal Stenosis, Blood Loss, Surgical
Related terms Blood Loss, Surgical
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov