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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discarded blood samples | Other | Will utilize the discarded blood from routine clinical blood samples to evaluate the role of immune cells in coagulopathy. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Thrombosis | Presence of clinical thrombosis | Through study completion; on average one year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients (all ages) undergoing complex cardiac surgical procedures with cardiopulmonary bypass (CPB) at Boston Children's Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koichi Yuki, MD | Contact | 617-355-6225 | koichi.yuki@childrens.harvard.edu | |
| Rachel Bernier | Contact | 857-218-5348 | Rachel.Bernier@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Koichi Yuki, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41815387 | Derived | Alhamdan F, Sin YC, Malm E, Van Pelt H, Kim S, Higgins L, Chen Y, Yuki K. Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers. FASEB Bioadv. 2026 Mar 9;8(3):e70098. doi: 10.1096/fba.2026-00006. eCollection 2026 Mar. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |