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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 is a Phase 1 study that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 8 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01158729
The ClinicalTrials.gov registry entry for NCT01158729 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01158729 reports 0 study locations.
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.
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