Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT05847205
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-25', 'size': 1156718, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-26T07:16', 'hasProtocol': True}, {'date': '2022-01-25', 'size': 977440, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-05T06:56', 'hasProtocol': False}, {'date': '2022-01-25', 'size': 412222, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-26T07:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, Single arm, single-center'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-04-05', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new onset symptomatic thrombosis', 'timeFrame': 'up to 15 days post operative', 'description': 'Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction.'}], 'secondaryOutcomes': [{'measure': 'Major bleeding', 'timeFrame': 'up to 12 hours after surgery', 'description': 'The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with ahemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period'}, {'measure': 'Adverse events', 'timeFrame': 'up to 15 days post operative', 'description': 'Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['r-Hirudin', 'Thrombexx', 'post-operative', 'prophylaxis', 'DVT'], 'conditions': ['Prophylaxis of Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of r-Hirudin RB variant 15 mg in DVT prophylaxis post major orthopedic operations', 'detailedDescription': 'Prospective, Single arm, single-center\n\nPhase IV\n\n100 Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.\n\nPatients undergoing major orthopedic operations\n\nFor Events of Deep Vein Thrombosis (DVT) within 15 days post-op.) All of the patients underwent Routine bilateral compression Doppler.\n\nFor Clinical PE (Pulmonary Embolism) Events from Day of surgery and During Hospitalization period or end of study\n\nClinical PE events PE (Pulmonary Embolism) events were confirmed by spiral CT.\n\nFor follow up:\n\nAPTT should be done before the first dose then after 4 \\& 8 hours of the first dose, then on days 1,8,15 post operatively.\n\nEnrolment period: 3 months duration Follow-up duration: Follow-up per patient will be for a period of 15 days\n\nPrimary endpoint:\n\n• Primary end points included new onset symptomatic thrombosis requiring medical or surgical intervention or death due to thrombosis defined as fatal PE, ischemic stroke, mesenteric thrombosis, or myocardial infarction\n\nSecondary endpoint:\n\n* The Secondary end point of major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥ 2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the perioperative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.\n* Recording serious adverse events (SAE)/ adverse events (AE) during the study duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Body Weight \\>60 kg\n* Patients undergoing major orthopedic operations\n* Patients ready to sign informed consent form (ICF)\n* Patients should discontinue any agents that affect haemostasis prior to the study medication use unless strictly indicated. These agents include medications such as: anticoagulants, thrombolytics, non-steroidal anti- inflammatory agents (including Ketorolac tromethamine), preparations containing aspirin, systemic salicylates, ticlopidine, dextran 40, clopidogrel, other anti-platelet agents including glycoprotein IIb/IIIa antagonists or systemic glucocorticoids.\n\nExclusion Criteria:\n\n* Significant bleeding injury such as solid organ laceration or intracranial bleed at discretion of attending physician\n* Hypersensitivity to Hirudin or prior documented Allergy to its components\n* Pregnant or breast feeding\n* Hemorrhagic stroke in preceding 3 months\n* abnormal baseline coagulation characterized by an INR \\>1.4, obtained at the discretion of the treating clinician\n* Required therapeutic anticoagulation for atrial fibrillation, prior VTE, or mechanical heart valve\n* Patients with a history of coagulation disorder\n* Treatment with concomitant anti-platelet agent other than aspirin 326 mg or more daily (Platelet count\\< 100X109 /dl)\n* Active bleeding\n* Subjects with a life expectancy less than 1 month'}, 'identificationModule': {'nctId': 'NCT05847205', 'acronym': 'Thromb-001', 'briefTitle': 'Study Evaluation of Recombinant Hirudin in Prophylaxis of Post-Operative Deep Vein Thrombosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MinaPharm Pharmaceuticals'}, 'officialTitle': 'A Prospective, Single- Center, Phase IV, Interventional, Single Arm Trial for the Evaluation of Subcutaneous Recombinant Hirudin 15 mg (RB Variant) in Prophylaxis of Deep Vein Thrombosis (DVT) Post Major Orthopedic Operations', 'orgStudyIdInfo': {'id': 'THRIVE-DVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'r-Hirudin', 'description': 'Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.', 'interventionNames': ['Drug: r-Hirudin']}], 'interventions': [{'name': 'r-Hirudin', 'type': 'DRUG', 'otherNames': ['Thrombexx'], 'description': '100 Patients will be treated with r-Hirudin (Thrombexx) for a total of 15 days beginning with 15 mg BID s.c starting 6 hours after surgery or upon adequate hemostasis and continued until end of study.', 'armGroupLabels': ['r-Hirudin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '003', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman Dr Soliman, PhD', 'role': 'CONTACT', 'phone': '+20 100 1796219'}, {'name': 'Abdalla Dr Soliman, PhD', 'role': 'CONTACT', 'phone': '+20 111 1056406'}], 'facility': 'Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Ayman Dr Soliman, PhD', 'role': 'CONTACT', 'email': 'ssssoliman@gmail.com', 'phone': '+20 100 1796219'}, {'name': 'Abdalla Dr Hamad, PhD', 'role': 'CONTACT', 'phone': '+20 111 1056406'}], 'overallOfficials': [{'name': 'Ayman Dr Soliman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MinaPharm Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}