Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Cardiology, Hematology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2018 |
| Start Date: | October 2010 |
| End Date: | December 2012 |
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
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
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
