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NCT Number: NCT04299828

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6225

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Discarded blood samples

Other

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

Primary outcomes

  1. Monocyte activation status

    Time frame: Through study completion; on average one year

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

  2. Serum GABA and pro-inflammatory cytokines

    Time frame: Through study completion; on average one year

    Serum GABA and pro-inflammatory cytokines

Secondary outcomes

  1. Clinical Thrombosis

    Time frame: Through study completion; on average one year

    Presence of clinical thrombosis

Study contacts

Contact information is provided by the study sponsor or research team.

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6225

Rachel Bernier

CONTACT

[email protected]

857-218-5348

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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