Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01057420
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2010-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2010-01-25', 'studyFirstSubmitQcDate': '2010-01-26', 'lastUpdatePostDateStruct': {'date': '2010-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum amplitude in thrombelastography', 'timeFrame': '1 hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated.\n\n* Trial with medical device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* informed consent; no coagulation disorder or other illnesses;\n* non-smoker;\n* women: no pharmacological contraception, negative pregnancy test;\n* 25-45 years old; no medication; no acute or chronic airway problems;\n* for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic);\n* for 48 hours: no caffeine-containing drinks, no dark chocolate.\n\nExclusion criteria:\n\n* Lack of one of the inclusion criteria;\n* allergy or incompatibility to substances/materials applied in the study;\n* very thin veins/arteries.'}, 'identificationModule': {'nctId': 'NCT01057420', 'briefTitle': 'Effect of Hyperoxemia on Platelet Function in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Hyperoxemia on Platelet Function in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'O2Tc-2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Inhalation of 80% Oxygen', 'description': 'Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours', 'interventionNames': ['Drug: oxygen inhalation']}], 'interventions': [{'name': 'oxygen inhalation', 'type': 'DRUG', 'description': 'Inhalation of 80% oxygen via face mask', 'armGroupLabels': ['Inhalation of 80% Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Surgical Intensive Care Medicine', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Johannes Wacker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Surgical Intensive Care Medicine, UniversitaetsSpital Zuerich'}, {'name': 'Reto Stocker, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Surgical Intensive Care Medicine, UniversitaetsSpital Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Johannes Wacker, MD', 'oldOrganization': 'Surgical Intensive Care Medicine, UniversitaetsSpital Zurich'}}}}