Bone MetastasesNCT01696760
Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
A study testing acetylsalicylic acid, enoxaparin and PCD in people with Bone Metastases and Musculoskeletal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Musculoskeletal Cancer, Soft Tissue Sarcoma
- What is being tested?
- acetylsalicylic acid, enoxaparin and PCD
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- acetylsalicylic acid, enoxaparin, PCD
- Medical subject headings
- Sarcoma, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acidDrug
Also called ASA, Ecotrin, Empirin, Extren
325 mg twice a day
enoxaparinDrug
Also called Enoxaparin Sodium, Lovenox
40 mg once daily
PCDDevice
Also called thromboembolism prophylaxis, Flowtron calf compression
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acetylsalicylic acid and PCD) | Experimental | Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery. Receives: 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. Receives: Drug: enoxaparin; Device: PCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (6)
Pulmonary Embolism Rate
Measured: Up to 3 months
Development of Other Complications (Including Bleeding Complications)
Measured: Up to 3 months
Readmission Rate to Hopsital
Measured: Up to 3 months
Hematoma Formation
Measured: Up to 3 months
Excessive Wound Drainage
Measured: Up to 3 months
Death Rate
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Mayerson, Ohio State University Comprehensive Cancer Center
- Investigators
- Joel Mayerson, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696760
- Sponsor's protocol ID
- OSU-10055
- Other IDs
- NCI-2012-00894
- Status last verified
- Nov 2018
- First submitted
- 27 Sep 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
- ClinicalTrials.gov ID
- NCT01696760
- Acronym / sponsor ID
- OSU-10055
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acetylsalicylic acid and PCD) | Experimental | Drug: acetylsalicylic acid, Device: PCDPatients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery. |
| Arm II (enoxaparin and PCD) | Experimental | Drug: enoxaparin, Device: PCDPatients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acidAlso: ASA, Ecotrin, Empirin, Extren325 mg twice a day | Drug | Arm I (acetylsalicylic acid and PCD) |
| enoxaparinAlso: Enoxaparin Sodium, Lovenox40 mg once daily | Drug | Arm II (enoxaparin and PCD) |
| PCDAlso: thromboembolism prophylaxis, Flowtron calf compressionWear 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. | Device | Arm I (acetylsalicylic acid and PCD), Arm II (enoxaparin and PCD) |
Primary outcome
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.
6 secondary outcomes
Pulmonary Embolism Rate
Time frame: Up to 3 months
Development of Other Complications (Including Bleeding Complications)
Time frame: Up to 3 months
Readmission Rate to Hopsital
Time frame: Up to 3 months
Hematoma Formation
Time frame: Up to 3 months
Excessive Wound Drainage
Time frame: Up to 3 months
Death Rate
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Mayerson, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicylic acid, enoxaparin and PCD in people with Bone Metastases and Musculoskeletal Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DVT Incident Rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.