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Low Molecular Weight Heparin (LMWH) vs Aspirin for Venous Thromboembolism (VTE) Prophylaxis in Orthopaedic Oncology

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ClinicalTrials.gov Identifier: NCT03244020
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Santiago Lozano-Calderon, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Soft Tissue Sarcoma Bone Sarcoma Bone Metastases Venous Thromboembolism Hematoma Anticoagulant-induced Bleeding Drug: Aspirin 325mg Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: LMWH for Soft Tissue Sarcoma
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
 Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Enoxaparin 40 mg subcutaneous injection once daily
Other Name: Lovenox
Experimental: ASA for Soft Tissue Sarcoma
Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis
 Drug: Aspirin 325mg
Aspirin 325 mg by mouth once daily
Other Name: ASA
Experimental: LMWH for Primary Bone Tumor
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
 Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Enoxaparin 40 mg subcutaneous injection once daily
Other Name: Lovenox
Experimental: ASA for Primary Bone Tumor
Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis
 Drug: Aspirin 325mg
Aspirin 325 mg by mouth once daily
Other Name: ASA
Experimental: LMWH for Metastatic Disease
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
 Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
Enoxaparin 40 mg subcutaneous injection once daily
Other Name: Lovenox
Experimental: ASA for Metastatic Disease
Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis
 Drug: Aspirin 325mg
Aspirin 325 mg by mouth once daily
Other Name: ASA


Outcome Measures
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Primary Outcome Measures :
  1. Venous thromboembolism [ Time Frame: up to 6 months post operatively ]
    Deep venous thrombosis; pulmonary embolus


Secondary Outcome Measures :
  1. Hematoma formation [ Time Frame: up to 6 months post operatively ]
  2. Complication requiring return to operating room [ Time Frame: up to 6 months post operatively ]
    Return to operating room for any reason related to the original surgery

  3. Early chemoprophylaxis stop [ Time Frame: up to 4 weeks post operatively ]
    ASA or LMWH stopped prior to 4 weeks post operatively by surgeon for any reason

  4. Infection [ Time Frame: up to 6 months post operatively ]
    Infection requiring any sort of treatment (antibiotics alone, return to operating room)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic osseous disease of the lower extremities or pelvis treated with endoprosthetic reconstruction, curettage and cement packing with intramedullary nail fixation and/or plate and screws, or intramedullary nail fixation only.
  • Patients with primary bone sarcomas of the lower extremities or pelvis treated with wide resections and amputations or reconstruction with endoprosthesis, allografts, or allograft prosthetic composites.
  • Patients with soft tissue sarcomas of the lower extremities or pelvis measuring more than 8 cm in size, deep to the fascia levels, treated with preoperative or postoperative radiation, plus/minus preoperative and/or postoperative chemotherapy, receiving surgery with wide margins, followed by primary closure, closure with free or rotational, and/or skin graft. (478 patients per arm)

Exclusion Criteria:

  • Documented prior history of VTE
  • Pre-operative use of therapeutic or prophylactic chemical anti-coagulation at the time of surgery (not including ASA 81 mg)
  • Documented allergy/adverse reaction to either of the two study drugs
  • Presence of an inferior vena cava (IVC) filter
  • Known diagnosed hypercoagulable state (other than malignancy)
  • Inability to receive chemical anticoagulation
  • Pre-operative use of full strength aspirin 325 milligrams (mg) daily
  • Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244020


Locations
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United States, Massachusetts
Santiago Lozano-Calderon
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Santiago A Lozano-Calderon, MD, PhD Massachusetts General Hospital
More Information
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Responsible Party: Santiago Lozano-Calderon, Instructor of Orthopaedic Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03244020    
Other Study ID Numbers: 2017P000382
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Sarcoma
Osteosarcoma
Thromboembolism
Venous Thromboembolism
Hematoma
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
 Aspirin
Enoxaparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors