Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT05490160
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R time', 'timeFrame': 'day0 (pre-operative)', 'description': 'R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.'}, {'measure': 'R time', 'timeFrame': 'day3 (post-operative)', 'description': 'R time is the period from the initiation of the thrombelastography test till the beginning of the clot formation.'}, {'measure': 'K time', 'timeFrame': 'day0 (pre-operative)', 'description': 'K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.'}, {'measure': 'K time', 'timeFrame': 'day3 (post-operative)', 'description': 'K time is the period from the start of the clot formation to the curve reaches amplitude of 20mm in the thrombelastography.'}, {'measure': 'Alpha angle', 'timeFrame': 'day0 (pre-operative)', 'description': 'Alpha angle is the angle between the baseline and the tangent to the thrombelastography curve through the starting point of coagulation.'}, {'measure': 'Alpha angle', 'timeFrame': 'day3 (post-operative)', 'description': 'Alpha angle is the angle between the baseline and the tangent to the thrombelastography curve through the starting point of coagulation.'}, {'measure': 'Maximal amplitude (MA)', 'timeFrame': 'day0 (pre-operative)', 'description': 'Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.'}, {'measure': 'Maximal amplitude (MA)', 'timeFrame': 'day3 (post-operative)', 'description': 'Maximal amplitude (MA) is a direct measure of the highest point on the thrombelastography curve and represents clot strength.'}, {'measure': 'Clot index (CI)', 'timeFrame': 'day0 (pre-operative)', 'description': 'Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.'}, {'measure': 'Clot index (CI)', 'timeFrame': 'day3 (post-operative)', 'description': 'Clot index (CI) represents the haemostasis profile and is calculated based on R time, K time, Alpha angle and MA parameters.'}], 'secondaryOutcomes': [{'measure': 'Prothrombin time (PT)', 'timeFrame': 'day0 (pre-operative)', 'description': 'Prothrombin time (PT) is one of the parameters which reflects the coagulation function.'}, {'measure': 'Prothrombin time (PT)', 'timeFrame': 'day3 (post-operative)', 'description': 'Prothrombin time (PT) is one of the parameters which reflects the coagulation function.'}, {'measure': 'Activated partial thromboplastin time (APTT)', 'timeFrame': 'day0 (pre-operative)', 'description': 'Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.'}, {'measure': 'Activated partial thromboplastin time (APTT)', 'timeFrame': 'day3 (post-operative)', 'description': 'Activated partial thromboplastin time (APTT) is one of the parameters which reflects the coagulation function.'}, {'measure': 'Hemoglobin in g/L', 'timeFrame': 'day0 (pre-operative)', 'description': 'Hemoglobin is a parameter which reflects the blood loss or anemia.'}, {'measure': 'Hemoglobin in g/L', 'timeFrame': 'day3 (post-operative)', 'description': 'Hemoglobin is a parameter which reflects the blood loss or anemia.'}, {'measure': 'Red blood cell specific volume (HCT)', 'timeFrame': 'day0 (pre-operative)', 'description': 'Red blood cell specific volume (HCT) is a parameter which reflects the ratio of the red blood cells in the whole blood.'}, {'measure': 'Red blood cell specific volume (HCT)', 'timeFrame': 'day3 (post-operative)', 'description': 'Red blood cell specific volume (HCT) is a parameter which reflects the ratio of the red blood cells in the whole blood.'}, {'measure': 'Fibrinogen in g/L', 'timeFrame': 'day0 (pre-operative)', 'description': 'Fibrinogen is one of the parameters which reflects the coagulation function.'}, {'measure': 'Fibrinogen in g/L', 'timeFrame': 'day3 (post-operative)', 'description': 'Fibrinogen is one of the parameters which reflects the coagulation function.'}, {'measure': 'Platelet count in 10^9g/L', 'timeFrame': 'day0 (pre-operative)', 'description': 'Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.'}, {'measure': 'Platelet count in 10^9g/L', 'timeFrame': 'day3 (post-operative)', 'description': 'Plstelet count is a parameter which reflects the amount of the platelet in the whole blood.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Thrombelastography', 'Coagulation Function'], 'conditions': ['Arthropathy of Knee']}, 'descriptionModule': {'briefSummary': 'The main aim and scope of this study is making comparison about the thrombelastography and coagulation function in patients before and after the total knee arthroplasty with intra-articular tranexamic acid administration. The results may identify the influence of the intra-articular tranexamic acid administration on the relative coagulability monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients received primary total knee arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients received primary total knee arthroplasty;\n* Normal pre-operative coagulation function;\n* Complete surgery document, transfusion document and relative blood test.\n\nExclusion Criteria:\n\n* The patients received complicated total knee arthroplasty;\n* Abnormal pre-operative coagulation function caused by some diseases such as hepatic inadequacy, thrombocytopenia et al.\n* Incomplete documents.'}, 'identificationModule': {'nctId': 'NCT05490160', 'briefTitle': 'Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Alteration of Thrombelastography and Hemostatic Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration', 'orgStudyIdInfo': {'id': 'IIT-2022-0059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tranexamic acid group', 'description': 'During the total knee arthroplasty, the patients received a 2-g retrograde injection of tranexamic acid through the drain after closure, with subsequent clamping of the drain for 6 hours.', 'interventionNames': ['Drug: Tranexamic acid']}, {'label': 'Non-tranexamic acid group', 'description': 'During the total knee arthroplasty, the patients did not receive tranexamic acid administration.'}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': 'During the total knee arthroplasty, the patients received a 2-g retrograde injection of tranexamic acid through the drain after closure, with subsequent clamping of the drain for 6 hours.', 'armGroupLabels': ['Tranexamic acid group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lin Du', 'role': 'CONTACT', 'email': 'sato316@163.com', 'phone': '86-13817371926'}], 'overallOfficials': [{'name': 'Lin Du', 'role': 'STUDY_CHAIR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}