[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03244020":3,"trial-entities:NCT03244020":163,"trial-summary:NCT03244020":167},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":54,"secondary_outcomes":59,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":79,"locations":82,"central_contacts":156,"overall_officials":157,"references":161,"see_also_links":162},"NCT03244020","2017P000382","LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology","Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology","ENROLLING_BY_INVITATION","2028-07-01","2025-09","2025-10-03","2018-02-16","Massachusetts General Hospital","OTHER",false,"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\u002Flower 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\u002Flower extremity orthopaedic oncology procedures.","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\u002FPE in patients administered LMWH versus aspirin for prophylaxis; however there may exist a difference in the rate of wound complications between these prophylaxis methods.",[19,20,21,22,23,24,25],"Sarcoma","Soft Tissue Sarcoma","Bone Sarcoma","Bone Metastases","Venous Thromboembolism","Hematoma","Anticoagulant-induced Bleeding",[],"INTERVENTIONAL","PREVENTION",[30],"PHASE4",{"count":32,"type":33},2868,"ESTIMATED",[35,45],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":43},"DRUG","Aspirin 325mg","Aspirin 325 mg by mouth once daily",[40,41,42],"ASA for Metastatic Disease","ASA for Primary Bone Tumor","ASA for Soft Tissue Sarcoma",[44],"ASA",{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":52},"Enoxaparin 40Mg\u002F0.4mL Prefilled Syringe","Enoxaparin 40 mg subcutaneous injection once daily",[49,50,51],"LMWH for Metastatic Disease","LMWH for Primary Bone Tumor","LMWH for Soft Tissue Sarcoma",[53],"Lovenox",[55],{"measure":56,"description":57,"timeFrame":58},"Venous thromboembolism","Deep venous thrombosis; pulmonary embolus","Up to 3 or 6 months post operatively for bone\u002Fsoft tissue sarcomas and metastatic osseous disease, respectively",[60,62,65,69],{"measure":61,"timeFrame":58},"Hematoma formation",{"measure":63,"description":64,"timeFrame":58},"Complication requiring return to operating room","Return to operating room for any reason related to the original surgery",{"measure":66,"description":67,"timeFrame":68},"Early chemoprophylaxis stop","ASA or LMWH stopped prior to 4 weeks post operatively by surgeon for any reason","Up to 4 weeks post operatively",{"measure":70,"description":71,"timeFrame":58},"Infection","Infection requiring any sort of treatment (antibiotics alone, return to operating room)","ALL","18 Years",null,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"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\u002For 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\u002Fadverse 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\u002Fherself 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.",[80,81],"ADULT","OLDER_ADULT",[83,92,100,108,116,124,128,132,140,148],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"University of California Los Angeles Health","Los Angeles","California","90404","United States",{"lat":90,"lon":91},34.05223,-118.24368,{"facility":93,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"Moffitt Cancer Center","Tampa","Florida","33612",{"lat":98,"lon":99},27.94752,-82.45843,{"facility":101,"city":102,"state":103,"zip":104,"country":88,"geoPoint":105},"Louisiana State University Health","New Orleans","Louisiana","70112",{"lat":106,"lon":107},29.95465,-90.07507,{"facility":109,"city":110,"state":111,"zip":112,"country":88,"geoPoint":113},"Johns Hopkins University","Baltimore","Maryland","21287",{"lat":114,"lon":115},39.29038,-76.61219,{"facility":117,"city":118,"state":119,"zip":120,"country":88,"geoPoint":121},"Santiago Lozano-Calderon","Boston","Massachusetts","02114",{"lat":122,"lon":123},42.35843,-71.05977,{"facility":125,"city":118,"state":119,"zip":126,"country":88,"geoPoint":127},"Brigham and Women's Hospital","02115",{"lat":122,"lon":123},{"facility":129,"city":118,"state":119,"zip":130,"country":88,"geoPoint":131},"Beth Israel Deaconess Medical Center","02215",{"lat":122,"lon":123},{"facility":133,"city":134,"state":135,"zip":136,"country":88,"geoPoint":137},"University of Missouri-Columbia Cancer Care","Columbia","Missouri","65201",{"lat":138,"lon":139},38.95171,-92.33407,{"facility":141,"city":142,"state":143,"zip":144,"country":88,"geoPoint":145},"Cooper University Health Care","Camden","New Jersey","08103",{"lat":146,"lon":147},39.92595,-75.11962,{"facility":149,"city":150,"state":151,"zip":152,"country":88,"geoPoint":153},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":154,"lon":155},41.4995,-81.69541,[],[158],{"name":159,"affiliation":13,"role":160},"Santiago A Lozano-Calderon, MD, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":164,"biomarkers":166},[21,165,20],"Metastatic Malignant Neoplasm in the Bone",[],{"nct_id":4,"found":15,"summary":74,"prompt_version":74}]