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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 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02188576
The ClinicalTrials.gov registry entry for NCT02188576 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which high dose TXA is the first listed.
NCT02188576 reports 0 study locations.
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.
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