- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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 100 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to:
- Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels
- Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and
- Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rachel Bernier
- Phone Number: 857-218-5348
- Email: rachel.bernier@childrens.harvard.edu
Study Contact Backup
- Name: Juan Ibla, MD
- Phone Number: 617-355-6225
- Email: Juan.Ibla@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Juan Ibla, MD
- Phone Number: 617-355-6225
- Email: Juan.Ibla@childrens.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion; on average one year
|
Serum GABA and pro-inflammatory cytokines
Time Frame: Through study completion; on average one year
|
Serum GABA and pro-inflammatory cytokines
|
Through study completion; on average one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Thrombosis
Time Frame: Through study completion; on average one year
|
Presence of clinical thrombosis
|
Through study completion; on average one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan Ibla, MD, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00033314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Heart Disease
-
University of UlsterBelfast Health and Social Care TrustCompletedCongenital Heart Disease | Congenital Heart Defect | Adult Congenital Heart DiseaseUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiNational Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Disease CongenitalUnited States
-
Vanderbilt University Medical CenterEnrolling by invitationCongenital Heart Disease | Congenital Heart Defect | Congenital Heart MalformationsUnited States
-
YHAlattarNot yet recruitingCritical Congenital Heart Disease
-
University Hospital TuebingenCompletedComplex Congenital Heart DiseaseGermany
-
The Hospital for Sick ChildrenCompletedCongenital Heart Disease (CHD)Canada
-
University College, LondonSociety for Cardiothoracic Surgery in Great Britain & Ireland; British Congenital...Unknown
-
University of California, DavisCompletedCyanotic Congenital Heart DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleRecruitingComplex Congenital Heart DiseaseFrance
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI); Boston Children's HospitalEnrolling by invitation
Clinical Trials on Discarded blood samples
-
Boston Children's HospitalActive, not recruitingCongenital Heart DiseaseUnited States
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Boston Children's HospitalRecruitingAcute Kidney InjuryUnited States
-
AdventHealth Translational Research InstituteSanford-Burnham Medical Research Institute; Florida Hospital Cardiovascular...Active, not recruiting
-
Centre Georges Francois LeclercCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedHenoch Schönlein PurpuraFrance
-
Centre Hospitalier Universitaire DijonCompletedPrimary Immune Thrombocytopenia (ITP)France
-
Institut BergoniéUnknown
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownPaediatric MalignanciesFrance
-
Centre Hospitalier Universitaire DijonCompleted