Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-07 @ 6:06 AM
Study NCT ID:
NCT03826004
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clemastine in Cardiovascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002974', 'term': 'Clemastine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histamine concentration in plasma', 'timeFrame': 'Perioperative period', 'description': 'Plasma histamine concentration evaluated by ELISA'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Perioperative period', 'description': 'Invasive blood pressure of radial artery: systolic, diastolic and mean pressure'}, {'measure': 'Airway pressure', 'timeFrame': 'Perioperative period', 'description': 'Airway pressure: peak and plat'}, {'measure': 'Skin manifestation', 'timeFrame': 'Perioperative period', 'description': 'Rate of skin manifestations, including wheal, papules, maculopapules, etc'}, {'measure': 'Arrhythmia', 'timeFrame': 'Perioperative period', 'description': 'Rate of perioperative arrhythmia, especially tachycardia'}, {'measure': 'Specific symptoms', 'timeFrame': 'Perioperative period', 'description': 'Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Surgery', 'Histamine H1 Receptor Antagonist', 'Anaphylaxis'], 'conditions': ['Efficacy and Safety']}, 'descriptionModule': {'briefSummary': 'In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.', 'detailedDescription': 'In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old\n* Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Previous history of cardiac surgery\n* Allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol)\n* Myasthenia gravis\n* Porphyria patients\n* Bronchial asthma\n* Usage of monoamine oxidase (MAO) inhibitors\n* Pregnant or lactating women\n* Mentally or legally disabled patients'}, 'identificationModule': {'nctId': 'NCT03826004', 'briefTitle': 'Clemastine in Cardiovascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study', 'orgStudyIdInfo': {'id': 'Clemastine Pilot Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline solution 2ml before anesthetic induction', 'interventionNames': ['Drug: Saline Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Clemastine', 'description': 'Clemastine fumarate 2mg/2ml before anesthetic induction', 'interventionNames': ['Drug: Clemastine']}], 'interventions': [{'name': 'Clemastine', 'type': 'DRUG', 'description': 'Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle', 'armGroupLabels': ['Clemastine']}, {'name': 'Saline Solution', 'type': 'DRUG', 'description': 'Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jia Shi, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoticate Professor', 'investigatorFullName': 'SHI Jia', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}