Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-01-22 @ 2:02 AM
Study NCT ID:
NCT03343418
Status:
UNKNOWN
Last Update Posted:
2017-11-17
First Post:
2017-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-07', 'releaseDate': '2024-08-21'}], 'estimatedResultsFirstSubmitDate': '2024-08-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2017-10-10', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in coagulation parameters', 'timeFrame': 'Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration', 'description': 'Laboratory variables: Activated partial thromboplastin time \\[(aPTT) seconds\\], prothrombin time \\[(PT) seconds\\], haematocrit (%), haemoglobin(g/dl), fibrinogen(mg/dL), D dimer (ng/L), factor VIII(%), Von Willebrand factor(%), ROTEM \\[(INTEM, EXTEM, FIBTEM) Clotting Time (CT) and Clot Formation Time (CFT) seconds, alpha angle (α º), Maximum Clot Firmness (MCF) mm \\] and platelets aggregation (%)'}, {'measure': 'Postoperative blood loss', 'timeFrame': '48 hours', 'description': 'Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours'}], 'secondaryOutcomes': [{'measure': 'Blood transfusion', 'timeFrame': '30 days', 'description': 'Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU'}, {'measure': 'Reoperation for bleeding', 'timeFrame': '30 days'}, {'measure': 'Duration of Mechanical ventilation', 'timeFrame': '30 days'}, {'measure': 'Length of vasoactive drugs', 'timeFrame': '30 days'}, {'measure': 'Length of ICU stay', 'timeFrame': '30 days'}, {'measure': 'Clinical complications - renal failure, infection, myocardial ischemia, stroke', 'timeFrame': '30 days'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days'}, {'measure': 'Mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bleeding', 'Valve Cardiac Surgery', 'Desmopressin'], 'conditions': ['C.Surgical Procedure; Cardiac', 'Blood Coagulation Disorders']}, 'referencesModule': {'references': [{'pmid': '24951020', 'type': 'BACKGROUND', 'citation': 'Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.', 'detailedDescription': 'Patients with important valve disorders may evaluate with coagulopathy induced by mechanical effects (valvular stenosis or valvular insufficiency). Furthermore, frequently is required prophylactic use of antiplatelet drugs due to myocardial remodeling and antiarrhythmic conditions that may be associated. Patients with severe aortic stenosis may also acquired von Willebrand disease type 2A due to proteolysis of vonWillebrand factor. Despite of this, the treatment of valve disorders often requires cardiac surgery with cardiopulmonary bypass. On average 50 to 60% of patients undergoing cardiac surgery receive blood tranfusions. Blood cell transfusion is an independent risk factor for increased morbidity and mortality in critically ill patients. The use of desmopressin seems beneficial only in patients with congenital or acquired platelet dysfunction. In general population, such use is not validated due to inconclusive results of researches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Valve cardiac surgery with cardiopulmonary bypass.\n* Written informed consent\n\nExclusion Criteria:\n\n* Reoperative valve surgery\n* Hematocrit \\< 35%\n* Ventricular dysfunction (EF \\< 40%)\n* Infection\n* Body mass index \\> 35\n* Renal impairment (Creatinin \\> 2mg/dL)\n* Antiplatelet administration within 10 days preceding study surgery\n* Participation in another interventional clinical study within 30 days\n* Known or suspected hypersensitivity to the desmopressin\n* Coagulopathy (INR \\> 1.5)'}, 'identificationModule': {'nctId': 'NCT03343418', 'briefTitle': 'Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto do Coracao'}, 'officialTitle': 'Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery', 'orgStudyIdInfo': {'id': '3962.13.087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'desmopressin', 'description': 'Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.', 'interventionNames': ['Drug: Desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'description': 'Desmopressin is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given desmopressin 0,3 microgram.kg-1. After desmopressin infusion, bleeding treatment will follow the predefined standardized treatment regimen.', 'armGroupLabels': ['desmopressin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 100 milliliters (mL) 0.9% saline (SF0,9%). After 0.9% saline infusion, bleeding treatment will follow the predefined standardized treatment regimen.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Incor - Heart Institute - University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Coracao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Filomena R B G Galas', 'investigatorAffiliation': 'Instituto do Coracao'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-08-21', 'type': 'RELEASE'}, {'date': '2024-11-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Filomena R B G Galas, Associate Professor, Instituto do Coracao'}}}}