CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
IVIG +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02043379
NCT02043379N/ACompleted
CompareCT.gov

Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates

University of Alabama at Birmingham·interventional·Posted Jan 23, 2014·Updated Apr 13, 2017

In Brief

A clinical study evaluating IVIG and Placebo for Hypogammaglobulinemia and Congenital Heart Disease. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypogammaglobulinemia, Congenital Heart Disease
CountriesUnited States
CollaboratorsGrifols Biologicals, LLC

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 23, 2014
Enrollment StartMay 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago

Interventions

IVIGdrug

Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.

Placeboother

If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.