Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT06512233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017985', 'term': 'Dalteparin'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free Flap Survival Rate', 'timeFrame': 'two hourly for 1st 24 hours and then three hourly for next 48 hours and four hourly for next 72 hours and onwards.', 'description': 'Percentage of patients with successful survival of the free flap grafts at specified time points post-surgery'}], 'secondaryOutcomes': [{'measure': 'flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups', 'timeFrame': '30 days post-surgery', 'description': 'Number of participants experiencing complications requiring medical or surgical intervention within the first 30 days post-surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemia', 'Thrombosis', 'Vascular Complications', 'Surgical Wound Healing', 'Reconstructive Surgery Complications'], 'conditions': ['Complication,Postoperative']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to compare the effectiveness of heparin alone versus combination therapy of Heparin- Aspirin in improving free flap survival in patients undergoing reconstructive surgery. Participants will be randomly assigned to receive either heparin or a combination therapy, and the primary outcome measure will be the survival rate of the free flap at various time points post-surgery', 'detailedDescription': 'The objective of this randomized clinical trial is to evaluate the efficacy of heparin alone vs compared to combination therapy of Heparin-Aspirin in enhancing free flap survival in patients undergoing reconstructive surgery. Participants will be randomly assigned to one of two groups: one receiving standard heparin therapy and the other receiving a combination therapy that includes heparin and other agents. The primary outcome will be the survival rate of the free flap, assessed at multiple intervals after surgery. Secondary outcomes will to assess the incidence of flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups. Ethical approval will be obtained, and informed consent will be required from all participants. This trial seeks to provide robust evidence on the potential benefits of combination therapy over heparin alone in free flap survival, potentially informing future clinical guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing free flap surgery\n* Age between 18 and 70 years\n\nExclusion Criteria:\n\n* Known hypersensitivity to heparin or aspirin\n* History of bleeding disorders\n* Concurrent use of other anticoagulant or antiplatelet medications\n* Severe renal or hepatic impairment\n* Preoperative use of aspirin that could not be stopped five days before surgery due to a higher risk of cardiac-related complications.'}, 'identificationModule': {'nctId': 'NCT06512233', 'briefTitle': 'Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Dual Therapy Dilemma: Heparin Alone vs. Heparin-Aspirin Combo in Free Flap Survival', 'orgStudyIdInfo': {'id': '000000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LMW Heparin 5000 U/ML-Aspirin 75 MG', 'description': 'Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily along with tablet aspirin 75 MG once daily, for additional thromboprophylaxis for free flap. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.', 'interventionNames': ['Drug: LMW Heparin 5000 U/ML-Aspirin 75 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMW Heparin 5000 U/ML', 'description': 'Patients will receive 5000 unit of low molecular weight heparin subcutaneously once daily according to institutional protocol as routine practice for prevention of deep venous thrombosis in post operative period. The flaps of these patients will be monitored as standard clinical examination and outcome will be recorded until 4th post operative day.', 'interventionNames': ['Drug: LMW Heparin 5000 U/ML']}], 'interventions': [{'name': 'LMW Heparin 5000 U/ML-Aspirin 75 MG', 'type': 'DRUG', 'description': 'Arm 1', 'armGroupLabels': ['LMW Heparin 5000 U/ML-Aspirin 75 MG']}, {'name': 'LMW Heparin 5000 U/ML', 'type': 'DRUG', 'description': 'Arm 2', 'armGroupLabels': ['LMW Heparin 5000 U/ML']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Fizzah Arif, MD', 'role': 'CONTACT', 'email': 'fizzah.arif@aku.edu', 'phone': '+92 336 2230665'}, {'name': 'Ceemal Khan, BS', 'role': 'CONTACT', 'email': 'ceemal.khan@aku.edu', 'phone': '+ 92 333 1334859'}], 'overallOfficials': [{'name': 'Fizzah Arif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}, {'name': 'Fazlur Rahman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aga Khan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Ceemal Khan', 'investigatorAffiliation': 'Aga Khan University'}}}}