Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-01-01 @ 3:59 PM
Study NCT ID:
NCT00902057
Status:
UNKNOWN
Last Update Posted:
2009-05-14
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desmopressin for Bleeding Related to Low Body Temperature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-13', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'closure time on PFA-100', 'timeFrame': '3 hours'}]}, 'conditionsModule': {'conditions': ['Hypothermia Induced Impairment of Primary Haemostasis']}, 'descriptionModule': {'briefSummary': 'To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Healthy volunteers\n\nExclusion Criteria:\n\n1. Any known platelet or coagulation disorder.\n2. Pregnant or lactating women.\n3. Known chronic liver or renal disease.\n4. Coronary artery, carotid artery or peripheral artery disease\n5. Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.\n6. Smoker or alcohol user\n7. Mentally incapable of providing informed consent\n8. Students or junior staff members who had direct working relationship with the PI'}, 'identificationModule': {'nctId': 'NCT00902057', 'briefTitle': 'Desmopressin for Bleeding Related to Low Body Temperature', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'UW 09-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'desmopressin 1.5', 'interventionNames': ['Drug: desmopressin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'desmopressin 3', 'interventionNames': ['Drug: desmopressin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'desmopressin 15', 'interventionNames': ['Drug: desmopressin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'desmopressin', 'type': 'DRUG', 'description': 'single desmopressin subcutaneous injection, 1.5mcg', 'armGroupLabels': ['desmopressin 1.5']}, {'name': 'desmopressin', 'type': 'DRUG', 'description': 'single desmopressin subcutaneous injection, 3mcg', 'armGroupLabels': ['desmopressin 3']}, {'name': 'desmopressin', 'type': 'DRUG', 'description': 'single desmopressin subcutaneous injection, 15mcg', 'armGroupLabels': ['desmopressin 15']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'saline subcutaneous', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HKSAR', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, MBA', 'role': 'CONTACT', 'email': 'jkfng@hku.hk', 'phone': '(852) 28553303'}, {'name': 'Kwok F. J. Ng, MD,MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM', 'role': 'CONTACT', 'email': 'jkfng@hku.hk', 'phone': '(852) 28553303'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Kwok Fu Jacobus Ng', 'oldOrganization': 'Department of Anaesthesiology, the Univeristy of Hong Kong'}}}}