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Antithrombin III in Infants With Cardiopulmonary Bypass (CPB)

NCT01698567 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-03-22

No results posted yet for this 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.

Conditions

  • Congenital Heart Disease

Interventions

DRUG

Antithrombin III

ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity \[7\], goal 120% activity\[18\], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

DRUG

Placebo

placebo (normal saline) after induction of anesthesia and before commencement of bypass. ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity \[7\], goal 120% activity\[18\], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Michael Eaton, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
180 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01698567 on ClinicalTrials.gov