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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Coagulation
• Intervention / Treatment: Other: Discarded blood samples

Detailed Description

Often when people undergo heart surgery, they are placed on cardiopulmonary bypass (CPB). Sometimes clotting of the blood occurs during and after heart surgery with CPB, which can lead to multiple complications. In order to try to avoid abnormal/excessive clotting that may lead to complications, it is important to understand the specific causes of why the blood sometimes clots abnormally during and after heart surgery.

Currently, tests looking at how the blood clots (coagulation assessment) are usually performed as standard laboratory testing during and after surgery. However, these tests are not able to predict the future development of abnormal clots.

This study will be looking at the role that immune cells (monocytes) have in the formation of abnormal clots after heart surgery. It is possible that these immune cells produce signals that can contribute to the formation of clots. Using experimental tests (monocyte analysis and mediator analysis), the hope is to understand if these cells participate in forming abnormal clots in any meaningful way. Although these tests are not yet approved for use in children, this study plans to use these new methods to understand this phenomenon by analyzing the blood at different times during the surgery and recovery period.

Overall, the purpose of this study is to look at these tests in people undergoing heart surgery to help the investigators understand why the blood sometimes forms clots abnormally. Results from this study may help treat future patients who experience abnormal clotting during and after surgery.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Rachel Bernier; Phone Number: 857-218-5348; Email: Rachel.Bernier@childrens.harvard.edu
• Study Contact Backup: Name: Koichi Yuki, MD; Phone Number: 617-355-6225; Email: koichi.yuki@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Koichi Yuki, MD; Phone Number: 617-355-6225; Email: koichi.yuki@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Thrombosis	Presence of clinical thrombosis	Through study completion; on average one year

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Koichi Yuki, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Embolism and Thrombosis; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thrombosis; Heart Defects, Congenital
• Other Study ID Numbers: P00033314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No