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Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

18 Years
Open (Enrolling)
Bone Metastases, Musculoskeletal Cancer, Soft Tissue Sarcoma, Thromboembolism

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Trial Information

Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology


I. To perform a randomized prospective study to determine efficacy of acetylsalicylic acid
(ASA)+pneumatic compression device (PCD) prophylaxis compared to low-molecular weight
heparin (LMWH)+PCD in patients undergoing orthopaedic procedures for musculoskeletal
neoplasms (MSN) of the pelvis and lower extremity.

II. To prove that ASA+PCD is clinically equivalent to or better than LMWH+PCD in providing
deep vein thrombosis (DVT) prophylaxis in this patient population and results in fewer major
bleeding complications.

III. To measure rates of postoperative DVT and pulmonary embolism (PE) as primary outcomes.


I. To measure secondary outcomes including rates of readmission, reoperation, bleeding
complications (including hematoma formation and prolonged wound drainage), and death.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive acetylsalicylic acid orally (PO) twice daily (BID) and wear PCD on
days 1-28 after surgery.

ARM II: Patients receive enoxaparin subcutaneously (SC) once daily (QD) and wear PCD on days
1-28 after surgery.

After completion of study treatment, patients are followed up at 2 weeks, 6 weeks, and 3

Inclusion Criteria:

-Scheduled or to be scheduled for surgery performed on neoplasms of the pelvis or lower
limbs, including both primary musculoskeletal lesions as well as metastatic lesions; these
neoplasms may include major tumor resections, metastatic and pathologic fractures of the
hip and lower extremities (LE), open biopsies, and primary malignant tumors; an active
malignant neoplasm must be present at the time of surgery

Exclusion Criteria:

- Prior history of DVT or PE

- Previously placed vena cava filter

- No detectable malignant disease at the time of operation

- Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident

- Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis); excluded
if platelets < 50,000

- Preoperative anticoagulation or active/serious bleeding in past 2 weeks (prothrombin
time [PT] & partial thromboplastin time [PTT] > 1.6 & > 35)

- Hypersensitivity or allergy to aspirin or heparin (including those diagnosed with
heparin-induced thrombocytopenia)

- Conditions associated with bleeding (active ulcer disease, recent neurosurgery,
bleeding disorders)

- Patients with renal insufficiency (creatinine [Cr] > 1.5)

- Pregnant patients

- Epidural anesthesia

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

DVT incident rate

Outcome Description:

This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.

Outcome Time Frame:

Up to 3 months

Safety Issue:


Principal Investigator

Joel Mayerson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Bone Metastases
  • Musculoskeletal Cancer
  • Soft Tissue Sarcoma
  • Thromboembolism
  • Neoplasm Metastasis
  • Thromboembolism
  • Bone Neoplasms
  • Bone Marrow Diseases
  • Sarcoma



Ohio State University Medical Center Columbus, Ohio  43210