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NCT02103114 · ClinicalTrials.gov registry record · Phase 2

Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery

A Phase 2 study, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
45
Enrollment target

NCT02103114 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 45 participants.

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The verdict

NCT02103114, a Phase 2 study, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
45 participants
Enrollment target

Study Summary

The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products. The investigators believe this benefit would extend into the post-operative period resulting in a decreased incidence of thrombosis generation, as represented by a decrease in fibrin degradation products in the ICU period.

Interventions

  • OTHER Placebo
  • DRUG Anti-thrombin III

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2014-06
Est. Completion 2016-07-01
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT02103114

The ClinicalTrials.gov registry entry for NCT02103114 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02103114 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02103114 about?

NCT02103114 is a clinical study titled "Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery". The purpose of this study is to test whether the administration of ATIII during the intra-operative period results in improved anticoagulation for cardiopulmonary bypass (CPB) and an attenuation of the activation of the coagulation cascade, as represented by a decrease in fibrin degradation products...

What is the current status of trial NCT02103114?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2014-06. Estimated completion is 2016-07-01.

What interventions are being tested in trial NCT02103114?

The interventions under investigation include: Placebo (OTHER), Anti-thrombin III (DRUG).

Who is sponsoring clinical trial NCT02103114?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.