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Efficacy of Amicar for Children Having Craniofacial Surgery

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Jan 2027 to Jan 2028 Completion date: Mar 2027 to Mar 2028v18 Show 1 more changeShow less
    • Completion date: Mar 2027 to Mar 2028
  2. Notable Primary completion date: Jan 2025 to Jan 2027 Completion date: Mar 2025 to Mar 2027v17 Show 1 more changeShow less
    • Completion date: Mar 2025 to Mar 2027
  3. Notable Primary completion date: Jan 2023 to Jan 2025 Completion date: Mar 2023 to Mar 2025v16 Show 1 more changeShow less
    • Completion date: Mar 2023 to Mar 2025
  4. Minor Primary completion date: Oct 2022 to Jan 2023 Completion date: Dec 2022 to Mar 2023v15 Show 1 more changeShow less
    • Completion date: Dec 2022 to Mar 2023
  5. Notable Lead sponsor: Vanderbilt University Medical Center to Children's National Research Institutev14
Show 12 earlier versionsHide 12 earlier versions
  1. Notable Lead sponsor: Srijaya K. Reddy to Vanderbilt University Medical Centerv13
  2. Notable Lead sponsor: Srijaya K. Reddy, MD, MBA to Srijaya K. Reddy Primary completion date: Oct 2021 to Oct 2022 · Completion date: Dec 2021 to Dec 2022 · Study site revisedv12 Show 3 more changesShow less
    • Primary completion date: Oct 2021 to Oct 2022
    • Completion date: Dec 2021 to Dec 2022
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary completion date: Oct 2019 to Oct 2021 Completion date: Dec 2019 to Dec 2021v11 Show 1 more changeShow less
    • Completion date: Dec 2019 to Dec 2021
  4. Notable Primary completion date: Oct 2018 to Oct 2019 Completion date: Dec 2018 to Dec 2019v10 Show 1 more changeShow less
    • Completion date: Dec 2018 to Dec 2019
  5. Notable Primary completion date: Jan 2018 to Oct 2018 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 44 to confirmed 22 · Completion date: Feb 2018 to Dec 2018 · 1 morev9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 44 to confirmed 22
    • Completion date: Feb 2018 to Dec 2018
    • Site details revised
  6. Minor 2 versions Re-verified since Aug 7, 2017, no change to tracked fieldsv7-v8
  7. Notable Primary completion date: Jan 2017 to Jan 2018 Completion date: Feb 2017 to Feb 2018v6 Show 1 more changeShow less
    • Completion date: Feb 2017 to Feb 2018
  8. Minor Re-verified, no change to tracked fieldsv5
  9. Notable Primary completion date: Jan 2016 to Jan 2017 Completion date: Feb 2016 to Feb 2017v4 Show 1 more changeShow less
    • Completion date: Feb 2016 to Feb 2017
  10. Minor Trial status: Enrolling by Invitation to Recruiting Primary completion date: Sep 2015 to Jan 2016 · Completion date: Nov 2015 to Feb 2016 · Site details revisedv3 Show 3 more changesShow less
    • Primary completion date: Sep 2015 to Jan 2016
    • Completion date: Nov 2015 to Feb 2016
    • Site details revised
  11. Notable Lead sponsor: Children's National Research Institute to Srijaya K. Reddy, MD, MBA Trial status: Not Yet Recruiting to Enrolling by Invitation · Site contact updatedv2 Show 2 more changesShow less
    • Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Site contact updated
  1. Minor 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.
The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery. The investigators hypothesize that Amicar will decrease intraoperative blood loss and decrease the need for perioperative blood product administration in children undergoing craniofacial surgery.
Trial Details
NCT Number NCT02229968
Lead Sponsor Children's National Research Institute
Conditions Craniosynostosis
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov