Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joel Mayerson, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01696760
First received: September 27, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Bone Metastases
Musculoskeletal Cancer
Soft Tissue Sarcoma
Thromboembolism
Drug: acetylsalicylic acid
Drug: enoxaparin
Device: PCD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • DVT Incident Rate [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pulmonary Embolism Rate [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Development of Other Complications (Including Bleeding Complications) [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Readmission Rate to Hopsital [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Hematoma Formation [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Excessive Wound Drainage [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Death Rate [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Enoxaparin Sodium
  • Lovenox
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696760

Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Joel Mayerson, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Joel Mayerson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01696760     History of Changes
Other Study ID Numbers: OSU-10055, NCI-2012-00894
Study First Received: September 27, 2012
Results First Received: June 4, 2014
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma
Thromboembolism
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014