Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT01930305
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Heating Transfusion on Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2013-07-17', 'studyFirstSubmitQcDate': '2013-08-23', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'serum concentration of inflammatory cytokine', 'timeFrame': 'change from baseline at 3hour, 6hour, 12hour, 24hour after transfusion'}], 'primaryOutcomes': [{'measure': 'Brain fuction during perioperative period', 'timeFrame': 'Change from baseline at post-transfusion 15min, 30min, 1hour, 2hour, 3 hour, 6hour, 12hour, 24hour', 'description': 'Brain function includes cerebral blood flow and cerebral oxygen saturation'}], 'secondaryOutcomes': [{'measure': 'the cognitive performance and the score of postoperative quality recovery scales ( PQRS)', 'timeFrame': 'Chang from baseline at 15min,40min,1day,3day and 7day postoperative lay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heating transfusion'], 'conditions': ['Blood Transfusion']}, 'descriptionModule': {'briefSummary': 'To inversitage whether routine warming of blood is harmful to brain fuction of sugical patients receiving massive transfusion.', 'detailedDescription': 'Hypothermia is an effective therapeutic intervention to reduce hypoxic ischemia brain injury in animal experiments and in clinics.In a recent study, it has been shown that perioperative warming was associated with a higher incidence of cognitive dysfunction in elderly patients.Therefore, we hypothesised that perioperative heating transfusion have a side effect on brain function of surgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult paitents scheduled for major surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients scheduled for major surgery under general anesthesia and they probably need a blood transfusion during the procedure.\n\nExclusion Criteria:•Patients with a history of stroke, central nervous system disease , metabolic disturbance, psychiatric illness, hearing impairment, drug abuse or unwilling to participate in assessment\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01930305', 'briefTitle': 'Effects of Heating Transfusion on Brain Function', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Effects of Heating Transfusion on Brain Function of Surgical Patients', 'orgStudyIdInfo': {'id': 'NXKJGG2012'}}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}], 'overallOfficials': [{'name': 'Xinli Ni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}