Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03244020
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-03
First Post:
2017-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'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'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three separate patient categories are being investigated in this trial. All patients are undergoing pelvic and/or lower extremity surgery for one of three possible conditions: 1) soft tissue sarcoma; 2) primary bone sarcoma; 3) metastatic bone disease. Within each of these groups, patients will be randomized to either aspirin or low molecular weight heparin (enoxaparin) for venous thromboembolism prophylaxis post operatively.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2868}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2017-08-05', 'studyFirstSubmitQcDate': '2017-08-05', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous thromboembolism', 'timeFrame': 'Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively', 'description': 'Deep venous thrombosis; pulmonary embolus'}], 'secondaryOutcomes': [{'measure': 'Hematoma formation', 'timeFrame': 'Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively'}, {'measure': 'Complication requiring return to operating room', 'timeFrame': 'Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively', 'description': 'Return to operating room for any reason related to the original surgery'}, {'measure': 'Early chemoprophylaxis stop', 'timeFrame': 'Up to 4 weeks post operatively', 'description': 'ASA or LMWH stopped prior to 4 weeks post operatively by surgeon for any reason'}, {'measure': 'Infection', 'timeFrame': 'Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively', 'description': 'Infection requiring any sort of treatment (antibiotics alone, return to operating room)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoma', 'Soft Tissue Sarcoma', 'Bone Sarcoma', 'Bone Metastases', 'Venous Thromboembolism', 'Hematoma', 'Anticoagulant-induced Bleeding']}, 'descriptionModule': {'briefSummary': 'Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity orthopaedic surgery for malignancy are lacking, however, as compared to the data and guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture surgery. In this clinical trial, our specific aim is to compare the post operative incidence of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic oncology procedures.', 'detailedDescription': 'Lower extremity orthopaedic surgery and malignancy are both known major risk factors for venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE prophylaxis in patients undergoing orthopaedic surgery, particularly joint arthroplasty. Far fewer data are available regarding the efficacy of various methods of pharmacologic VTE prophylaxis in patients undergoing surgery for primary or metastatic musculoskeletal malignancies as malignancy itself is known to confer a hypercoagulable state. The existing data, including published data from our institution, are almost exclusively from retrospective studies. Given the limited external validity of existing guidelines and limitations inherent in applying data from retrospective studies, a randomized, prospective study comparing two of the most common methods of pharmacologic VTE prophylaxis would help to guide clinical care of this patient population. In addition, large dead spaces susceptible to hematoma formation are often created from tumor resections in orthopaedic oncology. Our retrospective data suggest that hematoma formation may be an independent predictor of infection. An important risk of chemical VTE prophylaxis is an increased incidence of bleeding into these dead spaces, leading to hematomas. This illustrates the complexity of selecting a method of VTE prophylaxis in patients at both high risk of VTE and hematoma formation and the need for high quality data to guide clinical decision-making in this patient population.\n\nThe specific aim of this study is to compare the post operative incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolus (PE) between patients who receive low molecular weight heparin (LMWH) versus aspirin for prophylaxis after having undergone pelvic or lower extremity orthopaedic oncology surgery (primary bone sarcomas, soft tissue sarcomas, and metastatic osseous disease).\n\nOur secondary aim is to compare the incidence of hematoma formation and wound complications between these methods of pharmacologic prophylaxis in the aforementioned patient population.\n\nOur hypothesis is that there is no significant difference in the incidence rate of symptomatic DVT/PE in patients administered LMWH versus aspirin for prophylaxis; however there may exist a difference in the rate of wound complications between these prophylaxis methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients will first be evaluated for inclusion in a master observational study with the following inclusion criteria:\n\n1. Age ≥18 years\n2. Prior or planned surgery on the pelvis or lower extremity\n3. Fulfills one of the following:\n\n a. Cohort A: Metastatic osseous disease, undergoing: i. Endoprosthetic reconstruction ii. Curettage, cement packing, and fixation with nails, plates, and/or screws iii. Intramedullary nail fixation only b. Cohort B: Primary bone sarcoma, undergoing wide resection, amputation, or reconstruction with endoprosthesis, allograft, or allograft-prosthesis composite (APC).\n\n c. Cohort C: Primary soft tissue sarcoma ≥5 cm in diameter, undergoing wide resection\n4. Anticoagulation therapy was received or is planned.\n\nIn addition to fulfilling all the inclusion criteria in Part 1 of this study, participants must also not meet any of the below exclusion criteria in order to be eligible for randomization to either aspirin or LMWH.\n\nExclusion Criteria:\n\n1. Documented prior history of VTE.\n2. Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.\n3. Documented allergy/adverse reaction to either of the two study drugs.\n4. Presence of inferior vena cava (IVC) filter.\n5. Known, diagnosed hypercoagulable state (other than malignancy).\n6. Inability to receive chemical anticoagulation.\n7. Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded.\n8. Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.\n9. Pregnancy\n10. Fear of needles that prevents administration of LMWH.\n11. Inability to administer medications via needles.\n12. For patients with metastatic osseous disease, a Khorana score of ≥3.\n\nPregnancy testing, via a urine or blood test, is a routine part of pre-operative laboratory testing in patients scheduled to undergo orthopaedic surgeries. Attending surgeons may also choose to exclude any patient from randomization at their discretion.'}, 'identificationModule': {'nctId': 'NCT03244020', 'briefTitle': 'LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology', 'orgStudyIdInfo': {'id': '2017P000382'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMWH for Soft Tissue Sarcoma', 'description': 'Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis', 'interventionNames': ['Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'ASA for Soft Tissue Sarcoma', 'description': 'Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis', 'interventionNames': ['Drug: Aspirin 325mg']}, {'type': 'EXPERIMENTAL', 'label': 'LMWH for Primary Bone Tumor', 'description': 'Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis', 'interventionNames': ['Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'ASA for Primary Bone Tumor', 'description': 'Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis', 'interventionNames': ['Drug: Aspirin 325mg']}, {'type': 'EXPERIMENTAL', 'label': 'LMWH for Metastatic Disease', 'description': 'Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis', 'interventionNames': ['Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe']}, {'type': 'EXPERIMENTAL', 'label': 'ASA for Metastatic Disease', 'description': 'Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis', 'interventionNames': ['Drug: Aspirin 325mg']}], 'interventions': [{'name': 'Aspirin 325mg', 'type': 'DRUG', 'otherNames': ['ASA'], 'description': 'Aspirin 325 mg by mouth once daily', 'armGroupLabels': ['ASA for Metastatic Disease', 'ASA for Primary Bone Tumor', 'ASA for Soft Tissue Sarcoma']}, {'name': 'Enoxaparin 40Mg/0.4mL Prefilled Syringe', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Enoxaparin 40 mg subcutaneous injection once daily', 'armGroupLabels': ['LMWH for Metastatic Disease', 'LMWH for Primary Bone Tumor', 'LMWH for Soft Tissue Sarcoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Santiago Lozano-Calderon', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri-Columbia Cancer Care', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Health Care', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Santiago A Lozano-Calderon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Orthopaedic Surgery', 'investigatorFullName': 'Santiago Lozano-Calderon', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}