Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT01199627
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2010-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2010-09-07', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss (ml)', 'timeFrame': '4 hours'}, {'measure': 'blood loss 8 hours (ml)', 'timeFrame': '8 hours'}, {'measure': 'blood loss 24 hours (ml)', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['total hip replacement', 'tranexamic acid'], 'conditions': ['Hip Replacement, Total']}, 'descriptionModule': {'briefSummary': 'The bleeding caused by hip replacement surgery (CRT) is an important source of demand for blood in the hospital. Tranexamic acid (TXA) is a drug that has proved useful in reducing bleeding associated with other surgeries and CRT results have been positive, but the variety of dosages difficult to evaluate the results To determine the efficacy and safety of TXA in reducing bleeding caused by surgery of total hip replacement.\n\nPATIENTS: Patients ASA(American Society of Anesthesiologists) I-III that they are to perform hip replacement surgery and cementless unilateral total that have signed the informed consent.\n\nGroup A: 1st dose 15mg/kg of TXA in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.\n\nGroup B: 1st dose: 10mg/kg of TXA in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.\n\nGroup C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.\n\nSTATISTICAL ANALYSIS Comparison of blood loss in groups and comparison of adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or more\n* ASA I-III\n* No allergies tranexamic acid\n* Informed consent signed by patient\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* severe vascular ischemia (coronary or peripheral)\n* previous venous thrombosis, pulmonary embolism or embolic disease (atrial fibrillation, active neoplastic disease)\n* coagulopathy\n* Chronic treatment with ASA(acetylsalicylic acid) or NSAIDs (nonsteroidal anti-inflammatory drugs) prior to surgery without suspension\n* Hemoglobine \\<10\n* moderate renal impairment (creatinine\\> 2)\n* Cirrhosis\n* contraindication to prophylaxis with enoxaparin\n* Patients with a history of seizures.'}, 'identificationModule': {'nctId': 'NCT01199627', 'acronym': 'TXA-CRT', 'briefTitle': 'Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Basque Health Service'}, 'officialTitle': 'Tranexamic Acid Versus Placebo for the Reduction of Blood Loss in Total Hip Replacement Surgery - Randomized, Controlled and Double-masked Trial', 'orgStudyIdInfo': {'id': 'TXA-CRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.', 'interventionNames': ['Drug: A']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Group B: 1st dose: 10mg/kg of TXA (tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.', 'interventionNames': ['Drug: B']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'description': 'Placebo', 'interventionNames': ['Drug: C']}], 'interventions': [{'name': 'A', 'type': 'DRUG', 'description': 'Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.', 'armGroupLabels': ['A']}, {'name': 'B', 'type': 'DRUG', 'description': 'Group B: 1st dose: 10mg/kg of TXA(tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration.', 'armGroupLabels': ['B']}, {'name': 'C', 'type': 'DRUG', 'description': 'Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.\n\n2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration.', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01009', 'city': 'Vitoria-Gasteiz', 'state': 'Alava', 'country': 'Spain', 'facility': 'Txagorritxu Hospital', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Borja Barrachina, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osakidetza-Basque Country Health Service'}, {'name': 'Cesar Valero, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Osakidetza-Basque Country Health Service'}, {'name': 'Amanda Lopez, pharmacist', 'role': 'STUDY_CHAIR', 'affiliation': 'Osakidetza-Basque Country Health Service'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basque Health Service', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Francisco Borja Barrachina Larraza', 'oldOrganization': 'Basque Health Service'}}}}