Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT03145493
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2017-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004322', 'term': 'Drainage'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2017-03-03', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hb variation', 'timeFrame': '3 days after surgey', 'description': 'Difference between Hb levels measured in pre-op and on postoperatively day 3.'}], 'secondaryOutcomes': [{'measure': 'Number of blood transfusions', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'Number of blood transfusions'}, {'measure': 'Cost of blood transfusions', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'Cost of blood transfusions'}, {'measure': 'Cost of suction drains', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'Cost of suction drains'}, {'measure': 'Range of motion of knee', 'timeFrame': 'preoperative visit , at the end of surgery, and on post-op day 3', 'description': 'Range of motion of knee'}, {'measure': 'Length of hospital stay', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'Length of hospital stay'}, {'measure': 'additional surgery', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'possible causes for reoperation: hematoma drainage, infection, knee mobilization'}, {'measure': 'Clinical results', 'timeFrame': 'from admission till 2 months after surgery', 'description': 'Major complications'}, {'measure': 'KOOS score', 'timeFrame': 'At preoperative visit and post-operative visit of six weeks after surgery', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS); Scores are transformed to a 0-100 scale, 0: extreme knee problems, 100: no knee problems'}, {'measure': 'SF-12 score', 'timeFrame': 'At preoperative visit and post-operative visit of six weeks after surgery', 'description': 'SF-12® Health Survey (SF-12); Physical and Mental Health Composite Scores (PCS \\& MCS) ; Minimum value: 0 (lowest level of health), Maximum value: 100 (highest level of health)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drainage, Suction', 'tranexamic acid'], 'conditions': ['Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA.\n\nHypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.\n\nMethod\n\n* Randomized controlled trial\n* Monocentric, 3 surgeons\n* Randomisation by sealed envelopes', 'detailedDescription': 'During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral primary total knee arthroplasty\n\nExclusion Criteria:\n\n* TKA revision\n* Bilateral TKA\n* Patients that refuse transfusions\n* Contraindication to tranexamic acid use: allergy, thromboembolic history\n* Coagulopathy\n* Kidney failure'}, 'identificationModule': {'nctId': 'NCT03145493', 'briefTitle': 'Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': "(L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)", 'orgStudyIdInfo': {'id': 'CE 14.150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Usage of suction drains', 'description': 'Usage of suction drains', 'interventionNames': ['Device: drainage']}, {'type': 'NO_INTERVENTION', 'label': 'No usage of suction drains', 'description': 'No usage of suction drains'}], 'interventions': [{'name': 'drainage', 'type': 'DEVICE', 'description': 'Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain', 'armGroupLabels': ['Usage of suction drains']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Frédéric Lavoie, MD MSc FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}