Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-01 @ 3:35 AM
Study NCT ID:
NCT02864095
Status:
UNKNOWN
Last Update Posted:
2017-07-31
First Post:
2016-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss on post-operative day 1', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '1 months'}, {'measure': 'Number of patients with infection', 'timeFrame': '1 months'}, {'measure': 'Number of deep vein thrombosis cases', 'timeFrame': '1 months'}, {'measure': 'Number of pulmonary embolism cases', 'timeFrame': '1 months'}, {'measure': 'Number of plexus venosus leg muscle thrombosis', 'timeFrame': '1 months'}, {'measure': 'Serum levels of IL-10（Preoperation, intraoperation and post-operation）', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Serum levels of IL-6（Preoperation, intraoperation and post-operation）', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Serum levels of IL-1β（Preoperation, intraoperation and post-operation）', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Serum levels of TNF-α（Preoperation, intraoperation and post-operation）', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Haemoglobin (Hb)', 'timeFrame': '7 days'}, {'measure': 'Hematocrit (Hct)', 'timeFrame': '7 days'}, {'measure': 'Platelets (PLT)', 'timeFrame': '7 days'}, {'measure': 'Blood loss on post-operative day 3', 'timeFrame': '3 days'}, {'measure': 'Preoperation, intraoperation and post-operation R value (min) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Preoperation, intraoperation and post-operation K value (min) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Preoperation, intraoperation and post-operation Angle (deg) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Preoperation, intraoperation and post-operation MA (mm) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Preoperation, intraoperation and post-operation comprehensive index of blood clotting (CI) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Preoperation, intraoperation and post-operation LY30 (%) of thrombelastogram', 'timeFrame': 'Preoperation, intraoperation and up to 2 days post-operation'}, {'measure': 'Number of patients with blood transfusion', 'timeFrame': '7 days', 'description': 'Number of transfusion cases, number of units transfused and amount of transfusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Arthroplasty, Replacement, Hip', 'Epinephrine', 'Tranexamic acid'], 'conditions': ['Blood Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total hip arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between the ages of 20 and 75 who were diagnosed with as having osteoarthritis or osteonecrosis of the femoral head\n* Scheduled for an elective primary total hip arthroplasty\n* Those who were willing and able to return for follow-up over at least a 6-month postoperative period\n\nExclusion Criteria:\n\n* Acute coronary syndrome \\< 6 months\n* Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium \\< 3.0 mmol, alcohol abuse, premenopausal women\n* Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors\n* Patients with history of thromboembolic disease, bleeding disorder\n* Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation ) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)\n* Allergy to TXA'}, 'identificationModule': {'nctId': 'NCT02864095', 'briefTitle': 'The Effects of Low-dose Epinephrine Plus Tranexamic Acid on Perioperative Haemostasis and Inflammatory Reaction in Major Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'orgStudyIdInfo': {'id': 'Hip blood'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous epinephrine', 'description': 'Intravenous (IV) low dose epinephrine', 'interventionNames': ['Drug: Tranexamic acid (TXA)', 'Drug: Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Topical epinephrine', 'description': 'Topical epinephrine', 'interventionNames': ['Drug: Tranexamic acid (TXA)', 'Drug: Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'No epinephrine', 'interventionNames': ['Drug: Tranexamic acid (TXA)']}], 'interventions': [{'name': 'Tranexamic acid (TXA)', 'type': 'DRUG', 'description': 'IV and topical administration', 'armGroupLabels': ['Control', 'Intravenous epinephrine', 'Topical epinephrine']}, {'name': 'Epinephrine', 'type': 'DRUG', 'armGroupLabels': ['Intravenous epinephrine', 'Topical epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weinan Zeng, doctor', 'role': 'CONTACT', 'email': 'weinanzeng@163.com', 'phone': '+8615023100103'}], 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Yang', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}