Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery

NCT04299828 | Recruiting

• 1 other identifier: P00033314
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Coagulation; Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• Monocyte activation status

  characterization of monocyte activation status at baseline before surgery and throughout the course of CPB including post-operatively.

  Through study completion; on average one year

• Serum GABA and pro-inflammatory cytokines

  Serum GABA and pro-inflammatory cytokines

  Through study completion; on average one year

Secondary Outcomes (1)

• Clinical Thrombosis

  Through study completion; on average one year

Interventions

Discarded blood samples OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (all ages) undergoing complex cardiac surgical procedures with cardiopulmonary bypass (CPB) at Boston Children's Hospital.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Alhamdan F, Sin YC, Malm E, Van Pelt H, Kim S, Higgins L, Chen Y, Yuki K. Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers. FASEB Bioadv. 2026 Mar 9;8(3):e70098. doi: 10.1096/fba.2026-00006. eCollection 2026 Mar.

  PMID: 41815387 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Thrombosis

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Koichi Yuki, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koichi Yuki, MD

CONTACT

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

Rachel Bernier

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: May 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)