Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04299828

Conditions

Congenital Heart Disease

Coagulation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Discarded blood samples

Study Details

Brief summary:

The goal of this proposal is to prospectively collect data from a series of 200 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to:

1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels
2. Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and
3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.

Conditions

Congenital Heart Disease

Coagulation

Study ID

NCT04299828

Start date

May 31, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients (all ages) undergoing complex cardiac surgical procedures with CPB.

Exclusion Criteria:

  • undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent
  • patient in a moribund condition American Society of Anesthesiology (ASA 5) -patient with a hematological and/or oncological disease
  • Jehovah witnesses.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Discarded blood samples

Will utilize the discarded blood from routine clinical blood samples to evaluate the role of immune cells in coagulopathy.

Primary outcome measure

  • Monocyte activation status [ Time Frame: Through study completion; on average one year ]
  • Serum GABA and pro-inflammatory cytokines [ Time Frame: Through study completion; on average one year ]

Central Contacts and Locations

Central contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

Rachel Bernier

857-218-5348Rachel.Bernier@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-07.