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NCT02229968 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Amicar for Children Having Craniofacial Surgery
A Phase 2 study of Craniosynostosis, sponsored by Children's National Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT02229968: Active Phase 2 study of Craniosynostosis, sponsored by Children's National Research Institute.
NCT02229968 is a Phase 2 study of Craniosynostosis that is active but no longer recruiting, run by Children's National Research Institute. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229968, a Phase 2 study of Craniosynostosis, is active but no longer recruiting, sponsored by Children's National Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
As estimated blood loss is known to be inaccurate in this setting, mean intraoperative blood loss (in mL/kg) will be calculated using a formula previously described in this population.
Conditions Studied
Interventions
- DRUG normal saline
- DRUG Amicar (ε-aminocaproic acid)
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-10 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What the registry record for NCT02229968 still lists
NCT02229968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Craniosynostosis appearing as the primary indexed condition, and to 2 interventions - of which normal saline is the first listed.
NCT02229968 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02229968 about?
NCT02229968 is a clinical study titled "Efficacy of Amicar for Children Having Craniofacial Surgery". 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 bl...
What is the current status of trial NCT02229968?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2014-10. Estimated completion is 2027-03.
What conditions does trial NCT02229968 study?
This clinical trial studies the following conditions: Craniosynostosis.
What interventions are being tested in trial NCT02229968?
The interventions under investigation include: normal saline (DRUG), Amicar (ε-aminocaproic acid) (DRUG).
Who is sponsoring clinical trial NCT02229968?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02229968 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Craniosynostosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02229968's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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