Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-31 @ 8:26 PM
Study NCT ID:
NCT00972361
Status:
COMPLETED
Last Update Posted:
2011-08-26
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-25', 'studyFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2011-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adenoidectomy', 'Tonsillectomy', 'Ventilation Tubes', 'Preoperational screening', 'Coagulation Profile', 'Lupus anticoagulant'], 'conditions': ['Coagulation Abnormalities']}, 'descriptionModule': {'briefSummary': 'Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children.\n\nA proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery.\n\nThe purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.', 'detailedDescription': 'Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.\n\nThe data will include cause of referral, laboratory analysis performed and results.\n\nIf the data allows the outcome of the operation and bleeding complications, will also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.\n\nThe data will include cause of referral, laboratory analysis performed and results.\n\nIf the data allows the outcome of the operation and bleeding complications, will also recorded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery\n\nExclusion Criteria:\n\n* No exclusion are applicable'}, 'identificationModule': {'nctId': 'NCT00972361', 'briefTitle': 'Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?', 'orgStudyIdInfo': {'id': '0134-08-EMC'}}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Ariel Koren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pediatric Hematology Unit and Pediatric Dpt B', 'investigatorFullName': 'Dr Koren Ariel', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}