Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-05 @ 2:22 AM
Study NCT ID:
NCT03822793
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2018-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty
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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'randomized double blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'haemoglobin decrease in the perioperative period', 'timeFrame': 'Day 1 to Day 4', 'description': 'Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day'}], 'secondaryOutcomes': [{'measure': 'Tranexamic acid pharmacokinetics', 'timeFrame': 'Day 1', 'description': 'For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.'}, {'measure': 'D-Dimer kinetics', 'timeFrame': 'Day 1', 'description': 'For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.'}, {'measure': 'allogenic red blood cell transfusion', 'timeFrame': 'Day 1 to day 8', 'description': 'For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.'}, {'measure': 'severe anaemia', 'timeFrame': 'Day 1 to day 8', 'description': 'For severe anaemia (defined as a level of haemoglobin \\<10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin \\<10 gram by deciliter in the perioperative period.'}, {'measure': 'incidence of symptomatic thrombotic events and death', 'timeFrame': 'Day 1 to day 8', 'description': 'For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.'}, {'measure': 'occurrence of a seizure', 'timeFrame': 'Day 8', 'description': "The endpoint is a combined criteria endpoint involving either the clinical observation of a generalized tonic-clonic seizure or a partial seizure or an epilepsy confirmed by an electroencephalogram interpreted by a neurologist blinded to the patient's inclusion group."}, {'measure': 'number of adverse events', 'timeFrame': 'Day: 45', 'description': 'collection in medical records the adverse events at 45 days after surgery :\n\n* venous thrombo-embolism / arterial\n* hematoma leading to modification of rehabilitation or requiring revision surgery\n* infections of superficial or deep surgical site'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid (TXA)', 'arthroplasty', 'hip', 'Exacyl'], 'conditions': ['Arthropathy of Hip']}, 'referencesModule': {'references': [{'pmid': '41338640', 'type': 'DERIVED', 'citation': 'Zufferey PJ, Barrat E, Deygas B, Lanoiselee J, Ollier E. Dose-effect relationship of intravenous tranexamic acid on perioperative haemoglobin drop in total hip arthroplasty (PRADO study): study protocol for a randomised, double-blind, placebo-controlled, dose-response study. BMJ Open. 2025 Dec 3;15(12):e100265. doi: 10.1136/bmjopen-2025-100265.'}]}, 'descriptionModule': {'briefSummary': 'A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.', 'detailedDescription': 'This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requiring primary hip arthroplasty (less than 3 months)\n* Informed Consent from the patient or their legally authorized representative\n* Affiliation to French Social Security Healthcare system\n\nExclusion Criteria:\n\n* Hip fracture of less than 3 months\n* Bilateral hip arthroplasty or anterior approach to hip arthroplasty\n* Haemorrhagic surgery in the previous 2 weeks\n* Contraindication to tranexamic acid\n* Contraindication to apixaban\n* Chronic use of anticoagulant\n* Pregnancy\n* Previous participation to this study'}, 'identificationModule': {'nctId': 'NCT03822793', 'acronym': 'PRADO', 'briefTitle': 'A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study', 'orgStudyIdInfo': {'id': '18CH052'}, 'secondaryIdInfos': [{'id': '2018-004552-37', 'type': 'EUDRACT_NUMBER'}, {'id': '2022-502532-38-01', 'type': 'OTHER', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1: perfusion of 300 mg Exacyl', 'description': 'Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'interventionNames': ['Drug: Group 1: perfusion of 300 mg Exacyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: perfusion of 500 mg Exacyl', 'description': 'Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision..', 'interventionNames': ['Drug: Group 2: perfusion of 500 mg Exacyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: perfusion of 1000 mg Exacyl', 'description': 'Patient will be included in the group 3 by randomization and they will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'interventionNames': ['Drug: Group 3: perfusion of 1000 mg Exacyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: perfusion of 3000 mg Exacyl', 'description': 'Patient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'interventionNames': ['Drug: Group 4: perfusion of 3000 mg Exacyl']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Patient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.', 'armGroupLabels': ['Placebo']}, {'name': 'Group 1: perfusion of 300 mg Exacyl', 'type': 'DRUG', 'description': 'Patient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'armGroupLabels': ['Group 1: perfusion of 300 mg Exacyl']}, {'name': 'Group 2: perfusion of 500 mg Exacyl', 'type': 'DRUG', 'description': 'Patient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'armGroupLabels': ['Group 2: perfusion of 500 mg Exacyl']}, {'name': 'Group 3: perfusion of 1000 mg Exacyl', 'type': 'DRUG', 'description': 'Patient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'armGroupLabels': ['Group 3: perfusion of 1000 mg Exacyl']}, {'name': 'Group 4: perfusion of 3000 mg Exacyl', 'type': 'DRUG', 'description': 'Patient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.', 'armGroupLabels': ['Group 4: perfusion of 3000 mg Exacyl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Julien LANOISELEE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}