Clinical trial NCT04299828: Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Official title: Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Coagulation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (all ages) undergoing complex cardiac surgical procedures with cardiopulmonary bypass (CPB) at Boston Children's Hospital.

Brief summary: The goal of this proposal is to prospectively collect data from a series of 100 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monocyte activation status
timeFrame: Through study completion; on average one year
measure: Serum GABA and pro-inflammatory cytokines
timeFrame: Through study completion; on average one year
Secondary outcomes:
measure: Clinical Thrombosis
timeFrame: Through study completion; on average one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Juan Ibla, MD
role: PRINCIPAL_INVESTIGATOR
References: