Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01260818
Status:
UNKNOWN
Last Update Posted:
2011-12-01
First Post:
2010-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss as calculated from change in haematocrit', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Intra-operative blood loss', 'timeFrame': '1 day'}, {'measure': 'Postoperative blood loss', 'timeFrame': 'postoperative 4 hours, 1 day, 2 days, 7days respectively'}, {'measure': 'Hemoglobin levels', 'timeFrame': 'postoperative 4 hours, 1 day, 2 days, 7days respectively'}, {'measure': 'drainage volume', 'timeFrame': 'postoperative 1 day, 2 days'}, {'measure': 'Proportion of patients receiving transfusions', 'timeFrame': '7 days'}, {'measure': 'Incidence of deep vein thrombosis postoperatively', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tranexamic Acid'], 'conditions': ['Hip Replacement', 'Postoperative Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient who are to undergo elective total hip arthroplasty.\n* Must be primary arthroplasty.\n* Must be single-side arthroplasty.\n* Must be older than 18 years.\n\nExclusion Criteria:\n\n* Cemented arthroplasty.\n* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .\n* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).\n* Patients who have a past medical history of thrombi-embolism at any time.\n* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \\<24%).\n* Patients with documented DVT or PE at screening or in past three months.\n* Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.\n* Patients with any associated major illness (e.g., severe cardiac \\[New York Heart Association Class III or IV\\] or respiratory disease).\n* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.\n* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products."}, 'identificationModule': {'nctId': 'NCT01260818', 'briefTitle': 'Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine'}, 'officialTitle': 'Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery', 'orgStudyIdInfo': {'id': 'GZTCM-201001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'description': '1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'normal saline', 'type': 'DRUG', 'description': '100ml saline is kept in wound for 2 hours before drainage is opened postoperatively', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510405', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Li', 'role': 'CONTACT', 'email': 'liyong1949@gmail.com', 'phone': '86-02036591743'}], 'facility': 'the First Affiliated Hospital of Guangzhou TCM University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yong Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'the First Affiliated Hospital of Guangzhou TCM University', 'oldOrganization': 'the First Affiliated Hospital of Guangzhou TCM University'}}}}