Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02427412
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000068357', 'term': 'Saline Waters'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total estimated blood loss', 'timeFrame': '24 hours surgery'}], 'secondaryOutcomes': [{'measure': 'Total estimated blood loss', 'timeFrame': '2 days after surgery'}, {'measure': 'Thromboembolic complications', 'timeFrame': '90 days postoperative', 'description': '90 days followup for thromboembolic complications.'}, {'measure': 'Blood transfusion', 'timeFrame': 'while hospitalized expected 3 days.', 'description': 'Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic Acid', 'Knee Arthroplasty', 'Blood loss', 'Blood transfusion', 'Thrombolic complication', 'Total blood loss 24 h after ended surgery.', 'Total blood loss 2 days after ended surgery.'], 'conditions': ['Blood Loss', 'Postoperative Blood Loss', 'Thromboembolic Complications']}, 'descriptionModule': {'briefSummary': 'A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.', 'detailedDescription': 'Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.\n\nIn this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old\n* Unilateral knee replacement\n* Must be able to give oral and written consent\n\nExclusion Criteria:\n\n* General Anesthetized\n* Allergic to Tranexamic acid\n* In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.\n* Use of oral anticonceptive.\n* Reduced kidney function (S-creatinine \\> 120 micromol/L)\n* Medicine or alcohol abuse\n* Females with menstruation within the last 12 mounts.\n* Any kind of cancer disease\n* Rheumatoid arthritis\n* Have participated in a clinical trial within the last 30 days.'}, 'identificationModule': {'nctId': 'NCT02427412', 'briefTitle': 'Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'H-3-2013-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IA Tranexamic acid + IV Tranexamic Acid', 'description': '3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IA Saline Water + IV tranexamic Acid', 'description': '30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.', 'interventionNames': ['Drug: Saline water', 'Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Cyclokapron'], 'description': 'An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.', 'armGroupLabels': ['IA Tranexamic acid + IV Tranexamic Acid']}, {'name': 'Saline water', 'type': 'DRUG', 'otherNames': ['NaCl water'], 'description': '30 ml of Saline water injected into the knee capsula at the end of surgery.', 'armGroupLabels': ['IA Saline Water + IV tranexamic Acid']}, {'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Cyklocapron'], 'description': 'An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.', 'armGroupLabels': ['IA Saline Water + IV tranexamic Acid', 'IA Tranexamic acid + IV Tranexamic Acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Henrik Husted, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Christian Skovgaard Nielsen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}