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NCT01698567 · ClinicalTrials.gov registry record · Phase 1
Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)
A Phase 1 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01698567: Clinical Trial Phase 1 study, sponsored by University of Rochester.
NCT01698567 is a Phase 1 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01698567, a Phase 1 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
Primary Outcome
Patients treated with ATIII as standard of care (good clinical practice) will remain in the study and be analyzed by their intention to treat group. Review of our clinical experience shows that treatment with ATIII for heparin resistance occurs in 2-3% of cases. If there are more than two patients so treated, we will also perform an "as-treated" analysis.
Interventions
- DRUG Placebo
- DRUG Antithrombin III
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
Why NCT01698567 stopped before completion
NCT01698567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01698567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01698567 about?
NCT01698567 is a clinical study titled "Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)". The purpose of this study is to discern whether supplementation of Antithrombin III will decrease coagulation and inflammation associated with cardiopulmonary bypass in infants undergoing cardiac surgery.
What is the current status of trial NCT01698567?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-07. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01698567?
The interventions under investigation include: Placebo (DRUG), Antithrombin III (DRUG).
Who is sponsoring clinical trial NCT01698567?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01698567's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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