NCT00862407

Brief Summary

This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery. The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Oct 2008Dec 2030

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
19.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

20.3 years

First QC Date

March 13, 2009

Last Update Submit

April 7, 2026

Conditions

Cardio-Pulmonary Bypass

Keywords

Cardiopulmonary bypassNon-pulsatile perfusionPulsatile perfusionplasma proteins

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma proteins

    24 hours

Study Arms (2)

1

Non-pulsatile Group (conventional)

2

Pulsatile group (Alternate)

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

300 children (150 per perfusion system) ages 1 year to \< 18 years requiring CPB for cardiac surgery.

You may qualify if:

  • Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass.

You may not qualify if:

  • Patients older than 17 years will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and plasma samples

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Surgery, & Bioengineering

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

October 1, 2008

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)