Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic compression devices in preventing deep vein thrombosis in patients with pelvic and lower extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also known as sequential compression devices and are inflatable compression sleeves that are placed around patient's legs to reduce the risk of clot formation deep vein thrombosis. Pneumatic compression devices are made of a soft material that wraps around the lower leg and periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized patients wear these as a preventive measure. Pneumatic compression devices alone are not sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in patients with musculoskeletal tumors which have determined whether one drug is better than another. The knowledge gained from this study will determine whether aspirin and pneumatic compression devices is the same or better than enoxaparin and pneumatic compression devices in preventing deep vein thrombosis in this patient population and may result in fewer wound and bleeding complications

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma; Thromboembolism; Bone Metastases; Musculoskeletal Cancer
• Intervention / Treatment: Drug: enoxaparin; Drug: acetylsalicylic acid; Device: PCD

Detailed Description

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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 months.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 [CVA])
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (acetylsalicylic acid and PCD); Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.	Drug: acetylsalicylic acid; 325 mg twice a day; Other Names: ASA; Ecotrin; Empirin; Extren; Device: PCD; Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.; Other Names: thromboembolism prophylaxis; Flowtron calf compression
Experimental: Arm II (enoxaparin and PCD); Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.	Drug: enoxaparin; 40 mg once daily; Other Names: Lovenox; Enoxaparin Sodium; Device: PCD; Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.; Other Names: thromboembolism prophylaxis; Flowtron calf compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary Embolism Rate	Up to 3 months
Development of Other Complications (Including Bleeding Complications)	Up to 3 months
Readmission Rate to Hopsital	Up to 3 months
Hematoma Formation	Up to 3 months
Excessive Wound Drainage	Up to 3 months
Death Rate	Up to 3 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Joel Mayerson, MD, Ohio State University

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Embolism and Thrombosis; Sarcoma; Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: OSU-10055; NCI-2012-00894 (Registry Identifier: CTRP (Clinical Trial Reporting Program))