Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-05 @ 12:00 AM
Study NCT ID:
NCT02648295
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2015-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
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': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-25', 'studyFirstSubmitDate': '2015-12-18', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All time measurements which indicate various aspects of clotting cascade', 'timeFrame': '3 months', 'description': 'Data derived from the TEG which includes R, MA, LY30 (R = clotting factors, MA clot strength and platelet function and LY30 is fibrinolysis).'}], 'secondaryOutcomes': [{'measure': 'Blood loss and transfusions', 'timeFrame': '3 months', 'description': 'Estimated and Calculated blood loss and transfusion requirements'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Status Post Total Hip and Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Blood management is an important part of successful total joint replacement. Loss of blood and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has become a standard component to many blood management programs. It is used to treat or prevent excessive blood loss during surgery and in various medical conditions such as excessive bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from growing and causing problems. When this process becomes overactive it can result in excessive bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the relationship between TXA and thromboelastogram (TEG) results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults undergoing primary total hip and knee arthroplasty', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary total hip and knee arthroplasty patients presenting to WVU Center for Joint Replacement\n* 40-90 years old\n\nExclusion Criteria:\n\n* Known coagulopathy\n* History of venothrombotic event\n* Unstable angina\n* Recent Myocardial infarction (MI)\n* History of bleeding events\n* History of chronic anemia\n* Preoperative anemia\n* Current use of blood thinners including aspirin'}, 'identificationModule': {'nctId': 'NCT02648295', 'briefTitle': 'Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty', 'orgStudyIdInfo': {'id': '1509851949'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Effects of IV TXA on TEG in patients undergoing THA or TKA', 'type': 'PROCEDURE', 'description': 'Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Dietz, MD', 'investigatorAffiliation': 'West Virginia University'}}}}