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NCT02188576 · ClinicalTrials.gov registry record · Phase 4
The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT02188576: Completed Phase 4 study, sponsored by Boston Children's Hospital.
NCT02188576 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02188576, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
This research study is being performed to evaluate two different doses of Tranexamic acid (TXA) in children who have craniosynostosis and have been referred to Boston Children's Hospital for corrective surgery. This surgery is associated with significant blood loss and frequently requires the transfusion of blood. TXA is a medication that reduces the amount of bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an FDA-approved drug that is routinely used in infants and children undergoing major surgery including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to decrease both the amount of bleeding and the amount of blood transfusion needed. We would like to compare the different doses of TXA to see if a lower dose has the same effect on blood loss as a higher dose. We are also interested to learn why TXA seems to work better in some patients than in others. In order to study the effect of this drug we would like to give this drug to your child and measure the blood loss and the volume of blood given to your child during his/her surgery. The research is being done at two sites; Boston Children's Hospital and Gaslini Children's Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this study. We are planning to study a total of 68 infants and children from age 3 months to 6 years old scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini Children's Hospital.
Primary Outcome
Determine the efficacy ( as measured by blood loss and blood transfusion) of TXA in infants and children undergoing open craniofacial surgery with this lower dosage scheme.
Interventions
- DRUG high dose TXA
- DRUG Low dose TXA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-01 |
| Phase | Phase 4 |
What the finished NCT02188576 record still lists
NCT02188576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which high dose TXA is the first listed.
NCT02188576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02188576 about?
NCT02188576 is a clinical study titled "The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery". This research study is being performed to evaluate two different doses of Tranexamic acid (TXA) in children who have craniosynostosis and have been referred to Boston Children's Hospital for corrective surgery. This surgery is associated with significant blood loss and frequently requires the transf...
What is the current status of trial NCT02188576?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2014-08. Estimated completion is 2018-01.
What interventions are being tested in trial NCT02188576?
The interventions under investigation include: high dose TXA (DRUG), Low dose TXA (DRUG).
Who is sponsoring clinical trial NCT02188576?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02188576's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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