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LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Trial Status: enrolling by invitation
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.
Inclusion Criteria
Patients will first be evaluated for inclusion in a master observational study with the
following inclusion criteria:
1. Age ≥18 years
2. Prior or planned surgery on the pelvis or lower extremity
3. Fulfills one of the following:
a. Cohort A: Metastatic osseous disease, undergoing: i. Endoprosthetic
reconstruction ii. Curettage, cement packing, and fixation with nails, plates,
and/or screws iii. Intramedullary nail fixation only b. Cohort B: Primary bone
sarcoma, undergoing wide resection, amputation, or reconstruction with
endoprosthesis, allograft, or allograft-prosthesis composite (APC).
c. Cohort C: Primary soft tissue sarcoma ≥5 cm in diameter, undergoing wide
resection
4. Anticoagulation therapy was received or is planned.
In addition to fulfilling all the inclusion criteria in Part 1 of this study,
participants must also not meet any of the below exclusion criteria in order to be
eligible for randomization to either aspirin or LMWH.
Exclusion Criteria:
1. Documented prior history of VTE.
2. Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time
of surgery.
3. Documented allergy/adverse reaction to either of the two study drugs.
4. Presence of inferior vena cava (IVC) filter.
5. Known, diagnosed hypercoagulable state (other than malignancy).
6. Inability to receive chemical anticoagulation.
7. Preoperative use of full-strength aspirin 325 mg daily; patients already taking
aspirin 81 mg daily will not be excluded.
8. Inability for the patient him/herself to give informed consent due to delirium,
dementia, or any other reason.
9. Pregnancy
10. Fear of needles that prevents administration of LMWH.
11. Inability to administer medications via needles.
12. For patients with metastatic osseous disease, a Khorana score of ≥3.
Pregnancy testing, via a urine or blood test, is a routine part of pre-operative
laboratory testing in patients scheduled to undergo orthopaedic surgeries. Attending
surgeons may also choose to exclude any patient from randomization at their discretion.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03244020.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: Enrolling By Invitation
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
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
