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Tranexamic Acid to Reduce Blood Loss in Spine Surgery

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jul 2026 to Jul 2027v11
  2. Primary and study completion dates: Jul 2025 to Jul 2026 Study sites: 5 to 4 · Study description shortened, about 1 word · Collaborators expanded, about 5 words · 1 morev10 Show 4 more changesShow less
    • Study sites: 5 to 4
    • Study description shortened, about 1 word
    • Collaborators expanded, about 5 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Jul 2023 to Jul 2025v9
  4. Study sites revised (5)v8 See this version in full on ClinicalTrials.gov ↗
  5. Primary and study completion dates: Jul 2021 to Jul 2023 Eligibility criteria revised · Site details revised at 1 of 5 sitesv7 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site details revised at 1 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2019 to Jun 15, 2020 · Study sites: 3 to 5 · Eligibility criteria shortened, about 6 wordsv6 Show 3 more changesShow less
    • Start date changed from estimate of Oct 2019 to Jun 15, 2020
    • Study sites: 3 to 5
    • Eligibility criteria shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Oct 2018 to Oct 2019 Site contacts updated at 1 of 3 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 3 sites
  3. Primary completion date: Mar 2018 to Jul 2021 Start date: Dec 2016 to Oct 2018 · Completion date: Mar 2020 to Jul 2021 · Secondary endpoints revised (5)v4 Show 3 more changesShow less
    • Start date: Dec 2016 to Oct 2018
    • Completion date: Mar 2020 to Jul 2021
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Mar 2016 to Dec 2016 Eligibility criteria expanded, about 2 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Lead sponsor: Washington University School of Medicine to Columbia University Primary completion date: Jul 2016 to Mar 2018 · Start date: Jan 2015 to Mar 2016 · Primary endpoint revised · 6 morev2 Show 9 more changesShow less
    • Primary completion date: Jul 2016 to Mar 2018
    • Start date: Jan 2015 to Mar 2016
    • Primary endpoint revised
    • Study sites: 0 to 3
    • Completion date: Jul 2018 to Mar 2020
    • Secondary endpoints revised (5)
    • Study description shortened, about 567 words
    • Collaborators shortened, about 13 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  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.
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.
Trial Details
NCT Number NCT02314988
Lead Sponsor Columbia University
Collaborators: United States Department of Defense
Conditions Spinal Injuries, Spinal Deformity
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov