Health TrialsbyHealthPanel

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

ConditionsCongenital Heart DiseaseCoagulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Discarded blood samples

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Monocyte activation status

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

Time frame
Through study completion; on average one year
2

Serum GABA and pro-inflammatory cytokines

Serum GABA and pro-inflammatory cytokines

Time frame
Through study completion; on average one year

Secondary outcomes

1

Clinical Thrombosis

Presence of clinical thrombosis

Time frame
Through study completion; on average one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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