Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-30 @ 9:24 PM
Study NCT ID:
NCT02373969
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2015-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboelastogram During Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2015-02-22', 'studyFirstSubmitQcDate': '2015-02-22', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in coagulation status during and after surgery compared to pre-surgery', 'timeFrame': 'During and after surgery compared to pre-surgery'}, {'measure': 'Change in fibrinolytic activity during and after surgery compared to pre-surgery', 'timeFrame': 'During and after surgery compared to pre-surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Orthopedic Procedures, Tranexamic Acid']}, 'descriptionModule': {'briefSummary': 'Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.', 'detailedDescription': 'The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As described in eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Osteoarthrosis\n* TKR operation elective\n* ASA I-III\n\nExclusion Criteria:\n\n* TKR due to any reason but osteoarthrosis\n* known coagulation problems\n* platelets \\< 100,000/DcL\n* Hb \\< 12 g%\n* past thrombo-embolic event\n* treatment with aspiring during last week\n* treatment with NSAID's during last 48 hours\n* malignancy\n* known allergy to tranexamic acid\n* general anesthesia"}, 'identificationModule': {'nctId': 'NCT02373969', 'briefTitle': 'Thromboelastogram During Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid', 'orgStudyIdInfo': {'id': 'TEG-099-11'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}