LMWH Vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
- Conditions
- Bone MetastasesSoft Tissue SarcomaBone SarcomaHematomaAnticoagulant-induced BleedingSarcomaVenous Thromboembolism
- Interventions
- Registration Number
- NCT03244020
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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.
The 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).
Our secondary aim is to compare the incidence of hematoma formation and wound complications between these methods of pharmacologic prophylaxis in the aforementioned patient population.
Our 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 2868
Not provided
- Documented prior history of VTE.
- Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
- Documented allergy/adverse reaction to either of the two study drugs.
- Presence of inferior vena cava (IVC) filter.
- Known, diagnosed hypercoagulable state (other than malignancy).
- Inability to receive chemical anticoagulation.
- Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded.
- Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
- Pregnancy
- Fear of needles that prevents administration of LMWH.
- Inability to administer medications via needles.
- For patients with metastatic osseous disease, a Khorana score of ≥3.
Pregnancy 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LMWH for Primary Bone Tumor Enoxaparin 40Mg/0.4mL Prefilled Syringe 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 LMWH for Soft Tissue Sarcoma Enoxaparin 40Mg/0.4mL Prefilled Syringe 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 LMWH for Metastatic Disease Enoxaparin 40Mg/0.4mL Prefilled Syringe 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 ASA for Primary Bone Tumor Aspirin 325mg Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis ASA for Soft Tissue Sarcoma Aspirin 325mg Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis ASA for Metastatic Disease Aspirin 325mg Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis
- Primary Outcome Measures
Name Time Method Venous thromboembolism Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively Deep venous thrombosis; pulmonary embolus
- Secondary Outcome Measures
Name Time Method Early chemoprophylaxis stop Up to 4 weeks post operatively ASA or LMWH stopped prior to 4 weeks post operatively by surgeon for any reason
Infection Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively Infection requiring any sort of treatment (antibiotics alone, return to operating room)
Hematoma formation Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively Complication requiring return to operating room Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively Return to operating room for any reason related to the original surgery
Trial Locations
- Locations (10)
University of California Los Angeles Health
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Louisiana State University Health
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Missouri-Columbia Cancer Care
🇺🇸Columbia, Missouri, United States
Cooper University Health Care
🇺🇸Camden, New Jersey, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Santiago Lozano-Calderon
🇺🇸Boston, Massachusetts, United States