NCT03143348: ProCard

Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass

Completed Last updated 30 April 2019

What this trial tests

trial testing Single blood draw in Congenital Heart Defect in 38 participants. Completed in 15 April 2019.

Timeline

4 June 2017

Primary endpoint
15 April 2019

15 April 2019

Quick facts

Lead sponsor	University of Oklahoma
Status	Completed
Study type	OBSERVATIONAL
Enrollment	38
Start date	4 June 2017
Primary completion	15 April 2019
Estimated completion	15 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Single blood draw
• Multiple blood draws
• Multiple blood draws

Conditions studied

• Congenital Heart Defect — all drugs for Congenital Heart Defect →
• Cardiopulmonary Bypass — all drugs for Cardiopulmonary Bypass →
• Inflammatory Response — all drugs for Inflammatory Response →
• Low Cardiac Output Syndrome — all drugs for Low Cardiac Output Syndrome →

Sponsor

University of Oklahoma

Who can join

Under 6 Months, any sex, with Congenital Heart Defect or Cardiopulmonary Bypass. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluates the effect of heart-lung bypass on babies undergoing cardiac surgery. The investigators want to learn more about the inflammation that exposure to bypass creates in the body by studying markers of inflammation and cell injury in the bloodstream. Additionally, the investigators want to examine if these markers can predict which babies develop post-surgical complications. The hypothesis is that babies who undergo bypass will have higher levels of these markers than babies not exposed to bypass and that these markers will correlate with how the baby does clinically after surgery.

This study will evaluate markers via blood sampling in babies with congenital heart disease who do not undergo cardiac surgery, those that undergo surgery without bypass, and those that undergo surgery with bypass. The overall goal is that this study will lead to useful biomarkers and lay the groundwork for future novel therapies aimed at improving outcomes for babies who require heart-lung bypass.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical and Laboratory Predictors for the Development of Low Cardiac Output Syndrome in Infants Undergoing Cardiopulmonary Bypass: A Pilot Study.
   Drennan SE, Burge KY, Szyld EG, Eckert JV, et al · · 2021 · cited 12× · PMID 33670210 · DOI 10.3390/jcm10040712