Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT03583567
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2018-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002744', 'term': 'Chlorpheniramine'}, {'id': 'D011899', 'term': 'Ranitidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010632', 'term': 'Pheniramine'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'normal saline will be used as placebo in control group'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '37 minutes', 'description': 'Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.'}], 'secondaryOutcomes': [{'measure': 'Serum tryptase', 'timeFrame': '60 minutes', 'description': 'Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['protamine', 'antihistamine'], 'conditions': ['Protamine Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '36571171', 'type': 'DERIVED', 'citation': 'Suksompong S, Wongsripuemtet P, Srinoulprasert Y, Khamtuikrua C, Chaikittisilpa N. H1 and H2 antihistamines pretreatment for attenuation of protamine reactions after cardiopulmonary bypass: a randomized-controlled study. Ann Palliat Med. 2023 Jan;12(1):47-59. doi: 10.21037/apm-22-714. Epub 2022 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.\n\nThe reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.\n\nThere for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status 1-3\n* Schedule for open heart surgery\n\nExclusion Criteria:\n\n* History of allergy to the study drugs or protamine\n* History of previous cardiac surgery or received protamine\n* History of diabetes with insulin therapy'}, 'identificationModule': {'nctId': 'NCT03583567', 'briefTitle': 'Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'Si 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '0.9% Normal Saline', 'description': 'Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL', 'interventionNames': ['Drug: 0.9% Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorpheniramine and ranitidine', 'description': 'Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)', 'interventionNames': ['Drug: Chlorpheniramine and ranitidine']}], 'interventions': [{'name': 'Chlorpheniramine and ranitidine', 'type': 'DRUG', 'description': 'Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.', 'armGroupLabels': ['Chlorpheniramine and ranitidine']}, {'name': '0.9% Normal Saline', 'type': 'DRUG', 'description': 'Patient will receive normal saline as placebo.', 'armGroupLabels': ['0.9% Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sirilak Suksompong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}