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
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
DVT incident rate
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.
Up to 3 months
Joel Mayerson, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|