[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04299828":3,"trial-entities:NCT04299828":85,"trial-summary:NCT04299828":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":30,"secondary_outcomes":37,"sex":41,"minimum_age":14,"maximum_age":14,"healthy_volunteers":42,"eligibility_criteria":43,"std_ages":51,"locations":55,"central_contacts":70,"overall_officials":76,"references":79,"see_also_links":84},"NCT04299828","P00033314","Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery","RECRUITING","2026-12","2026-01","2026-01-07","2022-05-31","Boston Children's Hospital","OTHER",null,"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:\n\n1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels\n2. Understand the correlation between GABA and inflammatory cytokines (and\u002For activated monocytes) and\n3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.","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\u002Fexcessive 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.\n\nCurrently, 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.\n\nThis 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.\n\nOverall, 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.",[18,19],"Congenital Heart Disease","Coagulation",[],"OBSERVATIONAL",[],{"count":24,"type":25},100,"ESTIMATED",[27],{"type":13,"name":28,"description":29},"Discarded blood samples","Will utilize the discarded blood from routine clinical blood samples to evaluate the role of immune cells in coagulopathy.",[31,35],{"measure":32,"description":33,"timeFrame":34},"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",{"measure":36,"description":36,"timeFrame":34},"Serum GABA and pro-inflammatory cytokines",[38],{"measure":39,"description":40,"timeFrame":34},"Clinical Thrombosis","Presence of clinical thrombosis","ALL",false,{"inclusion":44,"exclusion":46,"raw_text":50},[45],"Patients (all ages) undergoing complex cardiac surgical procedures with CPB.",[47,48,49],"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\u002For oncological disease","Jehovah witnesses.","Inclusion Criteria:\n\n* Patients (all ages) undergoing complex cardiac surgical procedures with CPB.\n\nExclusion Criteria:\n\n* undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent\n* patient in a moribund condition American Society of Anesthesiology (ASA 5) -patient with a hematological and\u002For oncological disease\n* Jehovah witnesses.",[52,53,54],"CHILD","ADULT","OLDER_ADULT",[56],{"facility":12,"status":7,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":67},"Boston","Massachusetts","02115","United States",[62],{"name":63,"role":64,"phone":65,"email":66},"Koichi Yuki, MD","CONTACT","617-355-6225","koichi.yuki@childrens.harvard.edu",{"lat":68,"lon":69},42.35843,-71.05977,[71,72],{"name":63,"role":64,"phone":65,"email":66},{"name":73,"role":64,"phone":74,"email":75},"Rachel Bernier","857-218-5348","Rachel.Bernier@childrens.harvard.edu",[77],{"name":63,"affiliation":12,"role":78},"PRINCIPAL_INVESTIGATOR",[80],{"pmid":81,"type":82,"citation":83},"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\u002Ffba.2026-00006. eCollection 2026 Mar.",[],{"nct_id":4,"conditions":86,"biomarkers":87},[19,18],[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is an observational study planning to enroll 100 participants of all ages. It is not a randomized trial.","completed","Observational Study on Immune Cells and Clotting After Heart Surgery","This observational study aims to understand why some people develop abnormal blood clots after heart surgery, especially when a heart-lung machine (cardiopulmonary bypass or CPB) is used. Researchers will look at discarded blood samples from routine tests to study how certain immune cells, called monocytes, might contribute to clotting. They will measure the activity of these monocytes, as well as levels of GABA and other inflammatory signals in your blood. The goal is to see if there's a link between these factors and the formation of clots. This study is for patients of all ages undergoing complex heart surgery with CPB. The study's success will be measured by understanding the role of monocyte activation and inflammatory markers in clotting. The current recruitment status is unclear.","Your monocyte activation status and serum GABA and pro-inflammatory cytokines will be measured through study completion, on average one year.",125,"You would provide discarded blood samples from routine clinical blood draws during and after your heart surgery. These samples will be used for experimental tests.","Not stated in the trial record.",[28],"v2"]