Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology

NCT01696760 | Completed Results DMC

• 2 other identifiers: OSU-10055NCI-2012-00894
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Bone Metastases; Musculoskeletal Cancer; Soft Tissue Sarcoma; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Arm I (acetylsalicylic acid and PCD)

EXPERIMENTAL

Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.

Drug: acetylsalicylic acid; Device: PCD

Arm II (enoxaparin and PCD)

EXPERIMENTAL

Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.

Drug: enoxaparin; Device: PCD

Interventions

acetylsalicylic acid DRUG

325 mg twice a day

Also known as: ASA, Ecotrin, Empirin, Extren

Arm I (acetylsalicylic acid and PCD)

enoxaparin DRUG

40 mg once daily

Also known as: Enoxaparin Sodium, Lovenox

Arm II (enoxaparin and PCD)

PCD DEVICE

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.

Also known as: thromboembolism prophylaxis, Flowtron calf compression

Arm I (acetylsalicylic acid and PCD); Arm II (enoxaparin and PCD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Sarcoma; Thromboembolism

Interventions

Aspirin; Enoxaparin; enoxaparin sodium

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

Overall patient compliance for the study was low

Results Point of Contact

• Title: Joel Mayerson, MD
• Organization: The Ohio State University Comprehensive Cancer Center

joel.mayerson@osumc.edu

614-293-4420

Study Officials

• Joel Mayerson, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 1, 2012
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2018
• Results First Posted: July 4, 2014

Record last verified: 2018-11

Locations

US (1)