Low Molecular Weight Heparin (LMWH) vs Aspirin for Venous Thromboembolism (VTE) Prophylaxis in Orthopaedic Oncology
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer, Cancer, Cancer, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 16, 2018 |
| End Date: | July 1, 2024 |
Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic
methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing
these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity
orthopaedic surgery for malignancy are lacking, however, as compared to the data and
guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture
surgery. In this clinical trial, our specific aim is to compare the post operative incidence
of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic
oncology procedures.
methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing
these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity
orthopaedic surgery for malignancy are lacking, however, as compared to the data and
guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture
surgery. In this clinical trial, our specific aim is to compare the post operative incidence
of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic
oncology procedures.
Lower extremity orthopaedic surgery and malignancy are both known major risk factors for
venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE
prophylaxis in patients undergoing orthopaedic surgery, particularly joint arthroplasty. Far
fewer data are available regarding the efficacy of various methods of pharmacologic VTE
prophylaxis in patients undergoing surgery for primary or metastatic musculoskeletal
malignancies as malignancy itself is known to confer a hypercoagulable state. The existing
data, including published data from our institution, are almost exclusively from
retrospective studies. Given the limited external validity of existing guidelines and
limitations inherent in applying data from retrospective studies, a randomized, prospective
study comparing two of the most common methods of pharmacologic VTE prophylaxis would help to
guide clinical care of this patient population. In addition, large dead spaces susceptible to
hematoma formation are often created from tumor resections in orthopaedic oncology. Our
retrospective data suggest that hematoma formation may be an independent predictor of
infection. An important risk of chemical VTE prophylaxis is an increased incidence of
bleeding into these dead spaces, leading to hematomas. This illustrates the complexity of
selecting a method of VTE prophylaxis in patients at both high risk of VTE and hematoma
formation and the need for high quality data to guide clinical decision-making in this
patient population.
The specific aim of this study is to compare the post operative incidence of symptomatic deep
vein thrombosis (DVT) and pulmonary embolus (PE) between patients who receive low molecular
weight heparin (LMWH) versus aspirin for prophylaxis after having undergone pelvic or lower
extremity orthopaedic oncology surgery (primary bone sarcomas, soft tissue sarcomas, and
metastatic osseous disease).
Our secondary aim is to compare the incidence of hematoma formation and wound complications
between these methods of pharmacologic prophylaxis in the aforementioned patient population.
Our hypothesis is that there is no significant difference in the incidence rate of
symptomatic DVT/PE in patients administered LMWH versus aspirin for prophylaxis; however
there may exist a difference in the rate of wound complications between these prophylaxis
methods.
venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE
prophylaxis in patients undergoing orthopaedic surgery, particularly joint arthroplasty. Far
fewer data are available regarding the efficacy of various methods of pharmacologic VTE
prophylaxis in patients undergoing surgery for primary or metastatic musculoskeletal
malignancies as malignancy itself is known to confer a hypercoagulable state. The existing
data, including published data from our institution, are almost exclusively from
retrospective studies. Given the limited external validity of existing guidelines and
limitations inherent in applying data from retrospective studies, a randomized, prospective
study comparing two of the most common methods of pharmacologic VTE prophylaxis would help to
guide clinical care of this patient population. In addition, large dead spaces susceptible to
hematoma formation are often created from tumor resections in orthopaedic oncology. Our
retrospective data suggest that hematoma formation may be an independent predictor of
infection. An important risk of chemical VTE prophylaxis is an increased incidence of
bleeding into these dead spaces, leading to hematomas. This illustrates the complexity of
selecting a method of VTE prophylaxis in patients at both high risk of VTE and hematoma
formation and the need for high quality data to guide clinical decision-making in this
patient population.
The specific aim of this study is to compare the post operative incidence of symptomatic deep
vein thrombosis (DVT) and pulmonary embolus (PE) between patients who receive low molecular
weight heparin (LMWH) versus aspirin for prophylaxis after having undergone pelvic or lower
extremity orthopaedic oncology surgery (primary bone sarcomas, soft tissue sarcomas, and
metastatic osseous disease).
Our secondary aim is to compare the incidence of hematoma formation and wound complications
between these methods of pharmacologic prophylaxis in the aforementioned patient population.
Our hypothesis is that there is no significant difference in the incidence rate of
symptomatic DVT/PE in patients administered LMWH versus aspirin for prophylaxis; however
there may exist a difference in the rate of wound complications between these prophylaxis
methods.
Inclusion Criteria:
- Patients with metastatic osseous disease of the lower extremities or pelvis treated
with endoprosthetic reconstruction, curettage and cement packing with intramedullary
nail fixation and/or plate and screws, or intramedullary nail fixation only.
- Patients with primary bone sarcomas of the lower extremities or pelvis treated with
wide resections and amputations or reconstruction with endoprosthesis, allografts, or
allograft prosthetic composites.
- Patients with soft tissue sarcomas of the lower extremities or pelvis measuring more
than 8 cm in size, deep to the fascia levels, treated with preoperative or
postoperative radiation, plus/minus preoperative and/or postoperative chemotherapy,
receiving surgery with wide margins, followed by primary closure, closure with free or
rotational, and/or skin graft. (478 patients per arm)
Exclusion Criteria:
- Documented prior history of VTE
- Pre-operative use of therapeutic or prophylactic chemical anti-coagulation at the time
of surgery (not including ASA 81 mg)
- Documented allergy/adverse reaction to either of the two study drugs
- Presence of an inferior vena cava (IVC) filter
- Known diagnosed hypercoagulable state (other than malignancy)
- Inability to receive chemical anticoagulation
- Pre-operative use of full strength aspirin 325 milligrams (mg) daily
- Inability for the patient him/herself to give informed consent due to delirium,
dementia, or any other reason.
- Pregnancy
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