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NCT01158729 · ClinicalTrials.gov registry record · Phase 1
Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates
A Phase 1 study, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01158729: Clinical Trial Phase 1 study, sponsored by Medical College of Wisconsin.
NCT01158729 is a Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01158729, a Phase 1 study, was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as currently practiced at Children's Hospital of Wisconsin. We plan to enroll the first 60 sequential patients meeting criteria who consent to inclusion. The primary outcomes will be rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and ATIII levels during and after bypass to determine pharmacokinetics.
Primary Outcome
Mortality rate, incidence of ECMO support within 24 hours postoperatively, incidence of mediastinal exploration within 24 hours postoperatively, incidence of thrombotic disease at discharge (ultrasound or other radiographic evidence if obtained for routine patient care), incidence of intracranial hemorrhage (ultrasound or computed tomography if obtained for routine patient care), days to delayed sternal closure, days to cessation of mechanical ventilation, and days to hospital discharge in the e
Interventions
- OTHER Placebo
- DRUG Antithrombin (Recombinant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Why NCT01158729 stopped before completion
NCT01158729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01158729 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01158729 about?
NCT01158729 is a clinical study titled "Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates". A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as currently practiced at Childre...
What is the current status of trial NCT01158729?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2011-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01158729?
The interventions under investigation include: Placebo (OTHER), Antithrombin (Recombinant) (DRUG).
Who is sponsoring clinical trial NCT01158729?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01158729's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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