Nctid:
NCT06230640
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020141", "term"=>"Hemostatic Disorders"}, {"id"=>"D000001778", "term"=>"Blood Coagulation Disorders"}], "ancestors"=>[{"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000006474", "term"=>"Hemorrhagic Disorders"}], "browseLeaves"=>[{"id"=>"M21977", "name"=>"Hemostatic Disorders", "asFound"=>"Coagulopathy", "relevance"=>"HIGH"}, {"id"=>"M5059", "name"=>"Blood Coagulation Disorders", "asFound"=>"Coagulopathy", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M9560", "name"=>"Hemorrhagic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000006490", "term"=>"Hemostatics"}], "ancestors"=>[{"id"=>"D000003029", "term"=>"Coagulants"}], "browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M9579", "name"=>"Heparin", "relevance"=>"LOW"}, {"id"=>"M46053", "name"=>"Calcium heparin", "relevance"=>"LOW"}, {"id"=>"M9576", "name"=>"Hemostatics", "asFound"=>"Cystoscopy", "relevance"=>"HIGH"}, {"id"=>"M21320", "name"=>"Citric Acid", "relevance"=>"LOW"}, {"id"=>"M1837", "name"=>"Sodium Citrate", "relevance"=>"LOW"}, {"id"=>"M14342", "name"=>"Protamines", "relevance"=>"LOW"}, {"id"=>"M6259", "name"=>"Coagulants", "relevance"=>"LOW"}, {"id"=>"T382", "name"=>"Citrate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Fibrinolytic Agents", "abbrev"=>"FiAg"}, {"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Coagulants", "abbrev"=>"Coag"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>59}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Prolongation of the R in kaolin with heparinase (HKH) of TEG 6S platelet mapping® during cardiopulmonary bypass.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping and 5min after antagonization", "description"=>"The measurement of the R time (coagulation time in minutes) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory and using the TEG 6S platelet mapping® and global hemostasis® cartridge."}], "secondaryOutcomes"=>[{"measure"=>"Change in maximum amplitude HKH (MA HKH) of TEG 6S platelet mapping® during CPB.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping", "description"=>"The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge."}, {"measure"=>"Change in maximum amplitude in the presence of fibrinogen activator (MA ActF) of TEG 6S platelet mapping® during CPB.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping", "description"=>"The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge."}, {"measure"=>"Maximum amplitude change in the presence of arachidonic acid (MA AA) in TEG 6S platelet mapping® during CPB.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping", "description"=>"The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge."}, {"measure"=>"Maximum amplitude change in the presence of P2Y12 receptor activating ADP (MA ADP) of TEG 6S platelet mapping® during CPB.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping", "description"=>"The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge."}, {"measure"=>"Correlation between the R HKH time of TEG 6S platelet mapping® and the R CKH of TEG 6S citrated®.", "timeFrame"=>"After anesthetic induction; 30 min before aortic declamping and 5min after antagonization", "description"=>"The measurement of the various parameters (coagulation time R in minutes, maximum amplitude of the clot strength MA in millimeter mm) is automated by using a TEG 6S® analyzer from the Haemonetics laboratory, which is already available in our unit, and using the TEG 6S platelet mapping® and citrated® cartridge."}, {"measure"=>"Post-operative bleeding over the first 2 hours", "timeFrame"=>"during the 2 hours post-surgery", "description"=>"Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)"}, {"measure"=>"Post-operative bleeding over 12 hours in intensive care", "timeFrame"=>"during the 12 hours post-surgery", "description"=>"Volume measured by drains connected to graduated sterile jars. Blood volume in milliliters (mL)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Coagulopathy", "cardiac surgery", "cardiopulmonary bypass"], "conditions"=>["Coagulopathy", "Cardiopulmonary Bypass", "Cardiac Surgery"]}, "referencesModule"=>{"references"=>[{"pmid"=>"34643817", "type"=>"RESULT", "citation"=>"Yamamoto Y, Sato Y, Takahashi M, Yamamoto H, Echizen M, Uchida T. TEG6s Platelet Mapping assay for the estimation of plasma fibrinogen concentration during cardiovascular surgery: a single-center prospective observational study. J Anesth. 2022 Feb;36(1):79-88. doi: 10.1007/s00540-021-03009-4. Epub 2021 Oct 13."}]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective study to evaluate the predictive value of the TEG 6s platelet mapping® (TEG 6s® PM) performed during cardiopulmonary bypass (CPB) in the prediction of biological coagulopathy (determined by TEG 6S global hemostasis®), in cardiac surgery with high risk of bleeding.", "detailedDescription"=>"The aim of this prospective study is to evaluate the predictive value of the R time (HKH) given by the TEG 6s platelet mapping® performed during the CPB in the prediction of postoperative biological coagulopathy.\n\nIn order to evaluate its interest and to validate its use during cardiac surgery with high bleeding risk under CPB, we plan to compare 2 thromboelastographic tests in the detection of biological coagulopathy: TEG 6S citrated® (reference) and TEG 6S platelet mapping®. Biological coagulopathy is defined by a kaolin-heparinase assay coagulation/reaction time (CKH R) value of 7 min on TEG 6S citrated® (fibrinogen impairment defined by a Comparison of functional fibrinogen Maximal Amplitude (CFF MA) \\< 20 mm, and CKH MA impairment (\\< 60 mm), in accordance with established laboratory standard values."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Any subject undergoing cardiac surgery with cardiopulmonary bypass circulation and at high risk of bleeding and transfusion.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 18 years old or older\n* Cardiac surgery under cardiopulmonary bypass with high risk of bleeding defined among:\n* CPB with circulatory arrest\n* cardiac transplantation\n* Redo surgery\n* infective endocarditis\n* predicted duration of CBP ≥ 120 min\n* High transfusion risk defined by a Trust predictive score ≥ 3 (Transfusion Risk Understanding Scoring Tool)\n\nExclusion Criteria:\n\n* Patient with heparin allergy or heparin-induced thrombocytopenia\n* Use of direct oral anticoagulant (DAA) with anti-factor X activity (Apixaban, Rivaroxaban) \\< 72h, even if antagonized\n* Patient on partially or fully antagonized VKAs\n* Opposition to participation after a period of reflection\n* Adult protected by law (guardianship, curatorship)\n* Person deprived of liberty\n* Person participating in another study with an exclusion period still in progress\n* Patient not affiliated to a social security scheme or not benefiting from such a scheme\n* Pregnant or breast-feeding woman"}, "identificationModule"=>{"nctId"=>"NCT06230640", "acronym"=>"PREDIPOC", "briefTitle"=>"Evaluation of TEG 6S PM® During Cardiopulmonary Bypass to Detect Postoperative Biological Coagulopathy", "organization"=>{"class"=>"OTHER", "fullName"=>"University Hospital, Montpellier"}, "officialTitle"=>"Evaluation of TEG 6S Platelet Mapping® During Cardiopulmonary Bypass for Cardiac Surgery to Detect Postoperative Biological Coagulopathy", "orgStudyIdInfo"=>{"id"=>"RECHMPL23_0167"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"cardiac surgery with cardiopulmonary bypass", "description"=>"Any subject undergoing cardiac surgery with cardiopulmonary bypass and at high risk of bleeding and transfusion.", "interventionNames"=>["Diagnostic Test: In vitro medical diagnostic device TEG6s® Platelet Mapping"]}], "interventions"=>[{"name"=>"In vitro medical diagnostic device TEG6s® Platelet Mapping", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["Comparison between TEG 6S platelet mapping® and TEG 6S global hemostasis Assessment of platelet inhibition rate"], "description"=>"Preoperative period:\n\n* Pre-operative blood sampling, according to the usual practices of the unit before surgery\n* Collection of the patient's usual demographic characteristics\n\nper operative period :\n\n* After anesthetic induction:a TEG6S platelet mapping® sampled from the arterial catheter routinely placed after anesthetic induction\n* During the CPB, 30 min before aortic declamping: performing TEG 6S platelet mapping® (heparinized tube)\n* 5 min after heparin antagonization by protamine, after the weaning of the bypass, and before any transfusion: performing a TEG 6S citrate® (citrated tube)\n\nPost-operative period (resuscitation):\n\n• postoperative bleeding at 2 hours and during the first 12 hours.", "armGroupLabels"=>["cardiac surgery with cardiopulmonary bypass"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34295", "city"=>"Montpellier", "country"=>"France", "contacts"=>[{"name"=>"Benjamin Bourdois, Dr", "role"=>"CONTACT", "email"=>"b-bourdois@chu-montpellier.fr", "phone"=>"+334.67.33.59.58"}], "facility"=>"Département d'Anesthésie Réanimation cardio-thoracique - Hôpital Arnaud de Villeneuve - CHU Montpellier", "geoPoint"=>{"lat"=>43.61092, "lon"=>3.87723}}], "centralContacts"=>[{"name"=>"Benjamin Bourdois, MD", "role"=>"CONTACT", "email"=>"b-bourdois@chu-montpellier.fr", "phone"=>"04.67.33.59.58", "phoneExt"=>"+33"}], "overallOfficials"=>[{"name"=>"Benjamin Bourdois, MD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"University Hospital, Montpellier"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University Hospital, Montpellier", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
