Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-25 @ 7:08 PM
Study NCT ID:
NCT02228135
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9843}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-08-27', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dexamethasone Dosage', 'timeFrame': 'once at start of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tonsillectomy', 'Adenotonsillectomy']}, 'descriptionModule': {'briefSummary': 'This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children who have had tonsillectomy or adenotonsillectomy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing a tonsillectomy\n* Patients undergoing an adenotonsillectomy\n\nExclusion Criteria:\n\n* All patients with a known history of bleeding or clotting disorders, as well as those patients who had presented to Nationwide Children's Hospital main operating room for control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying facility will be excluded from the study."}, 'identificationModule': {'nctId': 'NCT02228135', 'briefTitle': 'The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB14-00588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non post-tonsillectomy hemorrhage', 'description': 'Children who do not have post-tonsillectomy hemorrhage.', 'interventionNames': ['Drug: Dexamethasone']}, {'label': 'Post-tonsillectomy hemorrhage', 'description': 'Children return to the hospital after surgery with post-tonsillectomy hemorrhage.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Non post-tonsillectomy hemorrhage', 'Post-tonsillectomy hemorrhage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicole Elsey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Nicole Elsey', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}