Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT03302195
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant is blinded to group assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control prospective trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 410}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allogeneic transfusions of red blood cells', 'timeFrame': 'Seven days post-operatively or until discharge, whichever comes first', 'description': 'Percentage of subjects avoiding any allogeneic transfusions of red blood cells'}], 'secondaryOutcomes': [{'measure': 'Allogeneic transfusions of blood products', 'timeFrame': 'Seven days post-operatively or until discharge, whichever comes first', 'description': 'Percentage of subjects avoiding any allogeneic transfusions'}, {'measure': 'Units of blood product transfusions', 'timeFrame': 'Seven days post-operatively or until discharge, whichever comes first', 'description': 'Number of units of transfused blood products'}, {'measure': 'Massive red blood cell transfusions', 'timeFrame': 'Seven days post-operatively or until discharge, whichever comes first', 'description': 'Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)'}, {'measure': 'Post-operative complications', 'timeFrame': 'Post-operatively from day 0 up to first hospital discharge', 'description': 'Monitoring the safety of strategies by monitoring post-operative complications'}, {'measure': 'Bleeding', 'timeFrame': 'Peroperative, 4 and 24 hours post-operative', 'description': 'Per- and post-operative bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heparin', 'Allogeneic blood product transfusions', 'Bleeding', 'Cardiac surgery', 'Obesity'], 'conditions': ['Cardiopulmonary Bypass', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).\n\nThe purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese patients (BMI ≥ 30kg/m2)\n* Planned cardiac surgery\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Permanent pacemaker\n* Known intolerance to protamine\n* Known or suspected allergy to the used antifibrinolytic agent\n* Refusal to receive blood products\n* Planned off pump coronary artery bypass\n* Planned peri-operative use of desmopressin\n* Known Heparin-induced thrombocytopenia\n* Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden\n* Known congenital bleeding disorders\n* Current endocarditis\n* Planned hypothermic circulatory arrest (\\<28C)\n* Two or more cardiac surgery procedures\n* Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)\n* Planned CPB priming with red blood cells\n* Any known autoimmune disease\n* Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism\n* Significant (≥50%) carotid artery stenosis\n* Patient dosed with low molecular weight Heparin less than 24h before surgery\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods\n* Confirmed ST elevation myocardial infarction (STEMI) within 7 days\n* Pre-operative platelet count \\<100,000/microliter\n* Anaemia (Hematocrit \\<32% for females, \\<35%for males)\n* Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days\n* Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery\n* International ratio (INR) \\>1.5 on the day of surgery in patients treated with vitamin K antagonist\n* Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)\n* Renal failure (creatinine ≥ 175 micromol/L or dialysis)\n* Current thromboembolic disease other than myocardial infarct\n* Patients who have pre-donated autologous blood\n* Patient presenting with a resistance to Heparin'}, 'identificationModule': {'nctId': 'NCT03302195', 'briefTitle': 'Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'Obesity-CPB-21117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.\n\nAn initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.', 'interventionNames': ['Drug: Heparin', 'Procedure: cardiopulmonary bypass pump flow rate']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group A', 'description': 'Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.\n\nAn initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.', 'interventionNames': ['Drug: Heparin', 'Procedure: cardiopulmonary bypass pump flow rate']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group B', 'description': 'Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.\n\nAn initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.', 'interventionNames': ['Drug: Heparin', 'Procedure: cardiopulmonary bypass pump flow rate']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group C', 'description': 'Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.\n\nAn initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.', 'interventionNames': ['Drug: Heparin', 'Procedure: cardiopulmonary bypass pump flow rate']}], 'interventions': [{'name': 'Heparin', 'type': 'DRUG', 'description': 'Based on patient body weight (UI/kg)', 'armGroupLabels': ['Control group', 'Intervention group A', 'Intervention group B', 'Intervention group C']}, {'name': 'cardiopulmonary bypass pump flow rate', 'type': 'PROCEDURE', 'description': 'Based on patient body weight (L/min/m2)', 'armGroupLabels': ['Control group', 'Intervention group A', 'Intervention group B', 'Intervention group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Hugo Tremblay, Bachelor', 'role': 'CONTACT', 'email': 'hugo.tremblay@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3797'}], 'facility': 'Hopital Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Hugo Tremblay, Bachelor', 'role': 'CONTACT', 'email': 'hugo.tremblay@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3797'}], 'overallOfficials': [{'name': 'Pierre Voisine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac surgeon', 'investigatorFullName': 'Pierre Voisine', 'investigatorAffiliation': 'Laval University'}}}}