Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-28 @ 2:08 AM
Study NCT ID:
NCT06384456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-28
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following DRF Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute post-op pain', 'timeFrame': '24 hours to 72 hours postoperatively', 'description': 'It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.'}], 'secondaryOutcomes': [{'measure': 'opioid use', 'timeFrame': '1, 2, and 6-week post-surgery', 'description': "Opioid use will be recorded on patients' medication diary"}, {'measure': 'persistent pain', 'timeFrame': '1, 2, and 6-week post-surgery', 'description': 'It will be assessed with VAS 0 to 10cm, with higher score indicating worse pain.'}, {'measure': 'unscheduled hand-related procedures', 'timeFrame': '1, 2, and 6-week post-surgery', 'description': 'clinic/emergency unit visits or any issue or events related to the condition that might lead participant to visit the emergency room, be seen by a doctor, or undergo any intervention more frequently than the usual visits'}, {'measure': 'Patient reported function', 'timeFrame': '1, 2, and 6-week post-surgery', 'description': 'will be assessed using the disabilities of the arm, shoulder and hand questionnaire (DASH) score 0 to 100, with higher score indicating more disability.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Distal Radius Fractures', 'acute pain', 'Topical tranexamic acid', 'Open Reduction and Internal FIxation', 'Placebo', 'Randomized Control Trial'], 'conditions': ['Distal Radius Fractures']}, 'referencesModule': {'references': [{'pmid': '40398932', 'type': 'DERIVED', 'citation': 'Lameire DL, Noori A, Abbas A, Persitz J, Baltzer H, Collett E, Veillette C, Chan A, Paul R. The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation: protocol for a randomised controlled trial at a quaternary care hand surgery centre - The TRADR study. BMJ Open. 2025 May 21;15(5):e095684. doi: 10.1136/bmjopen-2024-095684.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing open reduction internal fixation (Volar approach) for operative management of a distal radius fracture;\n* Aged 18 or older;\n* Provision of informed consent;\n* Cognitive ability and English-language skills required to complete outcome measures.\n\nExclusion Criteria:\n\n* Revision surgery or any additional operative management of ipsilateral wrist injury\n* Distal radius fracture treated with a dorsal approach\n* Known history of lymphedema or lymph node dissection in the operative extremity\n* Known chronic pain conditions, fibromyalgia, or polymyalgia rheumatic\n* Current user of opioids and/or on chronic opioids use\n* Known allergic reaction to TXA\n* Anticoagulant use not stopped in time for surgery as per thrombosis Canada guidelines (i.e. warfarin, acetylsalicylic acid, direct oral anticoagulants, etc.)\n* Previous thrombotic stroke or thromboembolic disorders (i.e. known previous DVT, PE, or clotting disorders)\n* Current pregnancy or breastfeeding\n* Previous neurologic injury causing paralysis of affected shoulder/arm\n* Severe cardio-respiratory disease (i.e. ASA Grade IV or higher).'}, 'identificationModule': {'nctId': 'NCT06384456', 'acronym': 'TRADR', 'briefTitle': 'Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following DRF Fixation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'The Effect of Topical TRanexamic Acid Vs. Placebo on Acute Postoperative Pain Following Distal Radius Fracture Fixation: a Randomized Controlled Trial - the TRADR Study', 'orgStudyIdInfo': {'id': '23-5708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical TRanexamic Acid', 'description': '10mL of 100mg/mL TXA in addition to the standard care', 'interventionNames': ['Drug: Topical TRanexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10mL of 100mg/mL normal saline in addition to the standard care', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topical TRanexamic Acid', 'type': 'DRUG', 'description': '10mL of 100mg/mL TXA will be administered into the surgical wound prior closure.', 'armGroupLabels': ['Topical TRanexamic Acid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10mL of 100mg/mL normal saline will be administered into the surgical wound prior closure.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Ryan Paul, MD', 'role': 'CONTACT', 'email': 'ryan.paul2@uhn.ca'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Ryan Paul', 'role': 'CONTACT', 'email': 'jhanna.bermudez@uhn.ca', 'phone': '416-603-5839'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ryan Paul', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}