[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468419":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":21,"responsibleParty":36,"collaborators":21,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":21,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":21,"maxAge":49,"enrollmentInfo":50,"targetDuration":21,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":66,"whyStopped":21,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":21},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TEG Arm","EXPERIMENTAL","All patients enrolled in the study will have up to four 0.5cc blood samples obtained specifically for TEG analysis at the following defined points (for a total of up to 2cc of blood) when other routine labs are drawn (via an existing intravenous line or arterial line placed for clinical care) :\n\n* Once at the beginning of the case\n* Once at the end of the case\n* Up to two times at the same time as arterial blood gas (ABG) samples (if drawn)\n\nThe research team will collect the following information from the electronic medical record and input it into the Internal REDCap database:\n\n* De-identified demographic data, including age, height, weight, and diagnosis\n* Preoperative, intraoperative, and postoperative laboratory values( including PT, PTT, INR and fibrinogen and platelets), as dictated by standard clinical practice\n* Time of TEG results printed and time delivered to anesthesiologist\n* Complications\u002FAdverse events within the first 48 hours postoperatively",[13,14],"Diagnostic Test: Thromboelastography (TEG)","Other: Anesthesia Provider Survey",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","Thromboelastography (TEG)","Thromboelastography (TEG) is a type of Viscoelastic testing (ROTEM is another example) and is a validated point of care method of dynamically assessing intraoperative coagulopathy via functional assay.",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Anesthesia Provider Survey","Pre-operative and post-operative provider surveys will be distributed to anesthesiologists caring for study subjects to assess knowledge, practice, and attitudes about TEG.",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Susan M. Goobie, MD, FRCPC","CONTACT","617-355-7737","susan.goobie@childrens.harvard.edu",{"name":33,"role":29,"phone":34,"phoneExt":21,"email":35},"Jocelyn Booth, BSN","857-218-4585","jocelyn.booth@childrens.harvard.edu",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Susan Goobie","Principal Investigator","100468419","teg-use-in-children-undergoing-procedures-with-high-anticipated-blood-loss-100468419",false,"NCT05379530","TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss","Thromboelastography (TEG) and Intraoperative Coagulation Management of Pediatric Patients Undergoing Procedures With High Anticipated Blood Loss","Inclusion Criteria:\n\n* Pediatric patients undergoing non-cardiac surgery at BCH with a high likelihood of blood transfusion. Specifically these are defined as a surgery with greater than 25% likelihood of transfusion of any non-albumin blood product.\n* Eligible surgeries include:\n* spinal surgery\n* laparotomy\n* liver transplant\n* craniofacial surgery\n* esophageal atresia\n* craniotomy\u002Fhemispherectomy\n* major abdominal surgery\n* major hip surgery\n* major plastic surgery\n\nExclusion Criteria:\n\n* Patients undergoing cardiac surgery or ECMO cannulation, as these surgeries are generally considered outside the scope of general pediatric surgery.\n* Patients presenting for emergent surgery\n* Patients undergoing surgeries off hours (between 8pm and 8 am), when TEG analysis is unobtainable",true,"ALL","20 Years",{"count":51,"type":52},60,"ESTIMATED","INTERVENTIONAL",[55],"NA","The research team proposes a prospective, observational study to better understand how TEG can be useful in guiding clinical practice in the Main OR for subject's undergoing high transfusion risk surgeries.\n\nIntraoperatively, transfusion of blood products is frequently required to restore oxygen carrying capacity, perfusion and improve coagulation. Both under and over transfusion pose significant risks, particularly to pediatric patients with small starting intravascular volumes. Thromboelastography (TEG) is a validated method of dynamically assessing intraoperative coagulopathy via functional assay. However, while FDA approved and widely used in the adult setting, TEG is not commonly utilized in the setting of bleeding pediatric patients.\n\nRecently, TEG has been made available at BCH for clinical purposes and is being used solely in the cardiac surgery setting. The investigators aim to provide TEG data for non-cardiac pediatric surgical cases with a high risk of intraoperative blood loss in order to assess the impact of this tool on intraoperative management.",[58,59,60],"Surgical Blood Loss","Surgical Hemorrhage","Post Operative Hemorrhage",[62,63,64,65],"thromboelastography","blood transfusion","viscoelastic test-guided","massive hemorrhage","NOT_YET_RECRUITING","2024-08-19",{"date":69,"type":70},"2024-08-20","ACTUAL",{"date":72,"type":52},"2025-01-01",{"date":74,"type":52},"2025-12-01",{"name":5,"class":6}]