Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-01 @ 10:06 PM
Study NCT ID:
NCT07089251
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative blood loss', 'timeFrame': 'Daily, till post-operative day 5', 'description': 'Calculated 24 h blood loss in mL, Hidden blood loss in mL, Hemoglobin levels in g/dL, Hematocrit levels as a percentage, Platelets count in cells/µL.'}], 'secondaryOutcomes': [{'measure': 'Thromboembolic complications', 'timeFrame': 'Daily, till post-operative day 5'}, {'measure': 'Hospitalization duration', 'timeFrame': 'Daily, till post-operative day 5'}, {'measure': 'Drug side effects (epinephrine + tranexamic acid)', 'timeFrame': 'Daily, till post-operative day 5'}, {'measure': 'Complications', 'timeFrame': 'Daily, till post-operative day 5', 'description': 'VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthroplasty, Total', 'Knee Arthritis, Osteoarthritis', 'Total Knee Anthroplasty', 'Blood Loss', 'Tranexamic Acid Use', 'Epinephrine']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty.\n\nAlso aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration', 'detailedDescription': 'Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.\n\nThe study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing knee joint arthroplasty.\n* Saudi and Non-Saudi Patient.\n* Patients who have Complete medical record.\n\nExclusion Criteria:\n\n* End stage renal disease\n* Liver cirrhosis\n* Coagulopathy\n* Pre-operative Hgb \\<10 5.\n* History of cerebrovascular accident or myocardial infarction in past 12 months.\n* History of Heart failure.\n* History of arrhythmia.\n* History of pheochromocytoma, thyrotoxicosis and glaucoma.\n* Pregnancy or breast feeding\n* History of Deep venous thrombosis or pulmonary embolism\n* Allergy to epinephrine or tranexamic acid'}, 'identificationModule': {'nctId': 'NCT07089251', 'briefTitle': 'The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery', 'orgStudyIdInfo': {'id': 'ICTR24/002/9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinephrine + Tranexamic Acid Group', 'description': 'The experimental group will receive both epinephrine and tranexamic acid', 'interventionNames': ['Drug: low-dose epinephrine and tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic Acid Group', 'description': 'The comparator group will receive only tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid (TXA) treatment']}], 'interventions': [{'name': 'low-dose epinephrine and tranexamic acid', 'type': 'DRUG', 'description': 'low-dose epinephrine and tranexamic acid', 'armGroupLabels': ['Epinephrine + Tranexamic Acid Group']}, {'name': 'Tranexamic Acid (TXA) treatment', 'type': 'DRUG', 'description': 'Tranexamic Acid', 'armGroupLabels': ['Tranexamic Acid Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz Medical City, Ministry of National Guard - Health Affairs', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Dr. Turki Althunayan', 'role': 'CONTACT', 'email': 'althunayan.tu@hotmail.com', 'phone': '+966 55 994 4782'}], 'overallOfficials': [{'name': 'Wazzan Aljuhani, MD, FRCSC, MBA, MMEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz Medical City, MNGHA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Orthopedic Surgeon', 'investigatorFullName': 'Wazzan Saleh ALJuhani', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}