Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01696760
Recruitment Status : Completed
First Posted : October 1, 2012
Results First Posted : July 4, 2014
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Mayerson, Ohio State University Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Bone Metastases Musculoskeletal Cancer Soft Tissue Sarcoma Thromboembolism Drug: acetylsalicylic acid Drug: enoxaparin Device: PCD Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
Actual Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:
  • 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. DVT Incident Rate [ Time Frame: Up to 3 months ]
    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 :
  1. Pulmonary Embolism Rate [ Time Frame: Up to 3 months ]
  2. Development of Other Complications (Including Bleeding Complications) [ Time Frame: Up to 3 months ]
  3. Readmission Rate to Hopsital [ Time Frame: Up to 3 months ]
  4. Hematoma Formation [ Time Frame: Up to 3 months ]
  5. Excessive Wound Drainage [ Time Frame: Up to 3 months ]
  6. Death Rate [ Time Frame: Up to 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01696760


Locations
Layout table for location information
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Joel Mayerson, MD Ohio State University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Joel Mayerson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01696760    
Other Study ID Numbers: OSU-10055
NCI-2012-00894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 1, 2012    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: December 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Thromboembolism
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Enoxaparin
Enoxaparin sodium
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
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
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics