SarcomaPhase 4NCT03244020
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
A Phase 4 study testing Aspirin 325mg and Enoxaparin 40Mg/0.4mL Prefilled Syringe in people with Sarcoma and Soft Tissue Sarcoma, run by Massachusetts General Hospital at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma
- What is being tested?
- Aspirin 325mg and Enoxaparin 40Mg/0.4mL Prefilled Syringe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,868 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Feb 2018to 1 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Documented prior history of VTE.
- Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
- Documented allergy/adverse reaction to either of the two study drugs.
- Presence of inferior vena cava (IVC) filter.
- Known, diagnosed hypercoagulable state (other than malignancy).
- Inability to receive chemical anticoagulation.
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- Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded.
- Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
- Pregnancy
- Fear of needles that prevents administration of LMWH.
- Inability to administer medications via needles.
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Santiago Lozano-Calderon
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cooper University Health Care
Camden, New Jersey, 08103
Cleveland Clinic
Cleveland, Ohio, 44195
University of Missouri-Columbia Cancer Care
Columbia, Missouri, 65201
University of California Los Angeles Health
Los Angeles, California, 90404
Louisiana State University Health
New Orleans, Louisiana, 70112
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma, Bone Metastases, Venous Thromboembolism, Hematoma
- Being tested
- Aspirin 325mg, Enoxaparin 40Mg/0.4mL Prefilled Syringe
- Medical subject headings
- Sarcoma, Bone Neoplasms, Venous Thromboembolism, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 325mgDrug
Also called ASA
Aspirin 325 mg by mouth once daily
Enoxaparin 40Mg/0.4mL Prefilled SyringeDrug
Also called Lovenox
Enoxaparin 40 mg subcutaneous injection once daily
| Study group | Role | What they receive |
|---|---|---|
| LMWH for Soft Tissue Sarcoma | Experimental | Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis Receives: Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe |
| ASA for Soft Tissue Sarcoma | Experimental | Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis Receives: Drug: Aspirin 325mg |
| LMWH for Primary Bone Tumor | Experimental | Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis Receives: Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe |
| ASA for Primary Bone Tumor | Experimental | Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis Receives: Drug: Aspirin 325mg |
| LMWH for Metastatic Disease | Experimental | Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis Receives: Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe |
| ASA for Metastatic Disease | Experimental | Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis Receives: Drug: Aspirin 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism
Deep venous thrombosis; pulmonary embolus
Measured: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Secondary outcomes (4)
Hematoma formation
Measured: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Complication requiring return to operating room
Return to operating room for any reason related to the original surgery
Measured: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Early chemoprophylaxis stop
ASA or LMWH stopped prior to 4 weeks post operatively by surgeon for any reason
Measured: Up to 4 weeks post operatively
Infection
Infection requiring any sort of treatment (antibiotics alone, return to operating room)
Measured: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start16 Feb 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three separate patient categories are being investigated in this trial. All patients are undergoing pelvic and/or lower extremity surgery for one of three possible conditions: 1) soft tissue sarcoma; 2) primary bone sarcoma; 3) metastatic bone disease. Within each of these groups, patients will be randomized to either aspirin or low molecular weight heparin (enoxaparin) for venous thromboembolism prophylaxis post operatively.
- Masking
- None (open label)
- Enrolment
- 2,868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Missouri-Columbia
- Responsible party
- Principal investigator, Santiago Lozano-Calderon, Massachusetts General Hospital
- Investigators
- Santiago A Lozano-Calderon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244020
- Sponsor's protocol ID
- 2017P000382
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2017
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
- ClinicalTrials.gov ID
- NCT03244020
- Acronym / sponsor ID
- 2017P000382
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Bone Sarcoma, Bone Metastases, Venous Thromboembolism, Hematoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,868 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Missouri-Columbia
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Three separate patient categories are being investigated in this trial. All patients are undergoing pelvic and/or lower extremity surgery for one of three possible conditions: 1) soft tissue sarcoma; 2) primary bone sarcoma; 3) metastatic bone disease. Within each of these groups, patients will be randomized to either aspirin or low molecular weight heparin (enoxaparin) for venous thromboembolism prophylaxis post operatively.
| Arm | Type | Receives |
|---|---|---|
| LMWH for Soft Tissue Sarcoma | Experimental | Drug: Enoxaparin 40Mg/0.4mL Prefilled SyringePatients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis |
| ASA for Soft Tissue Sarcoma | Experimental | Drug: Aspirin 325mgPatients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis |
| LMWH for Primary Bone Tumor | Experimental | Drug: Enoxaparin 40Mg/0.4mL Prefilled SyringePatients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis |
| ASA for Primary Bone Tumor | Experimental | Drug: Aspirin 325mgPatients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis |
| LMWH for Metastatic Disease | Experimental | Drug: Enoxaparin 40Mg/0.4mL Prefilled SyringePatients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis |
| ASA for Metastatic Disease | Experimental | Drug: Aspirin 325mgPatients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Documented prior history of VTE.
- Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
- Documented allergy/adverse reaction to either of the two study drugs.
- Presence of inferior vena cava (IVC) filter.
- Known, diagnosed hypercoagulable state (other than malignancy).
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 |
|---|---|---|
| Aspirin 325mgAlso: ASAAspirin 325 mg by mouth once daily | Drug | ASA for Metastatic Disease, ASA for Primary Bone Tumor, ASA for Soft Tissue Sarcoma |
| Enoxaparin 40Mg/0.4mL Prefilled SyringeAlso: LovenoxEnoxaparin 40 mg subcutaneous injection once daily | Drug | LMWH for Metastatic Disease, LMWH for Primary Bone Tumor, LMWH for Soft Tissue Sarcoma |
Primary outcome
Venous thromboembolism
Time frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Deep venous thrombosis; pulmonary embolus
4 secondary outcomes
Hematoma formation
Time frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Complication requiring return to operating room
Time frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Early chemoprophylaxis stop
Time frame: Up to 4 weeks post operatively
Infection
Time frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Santiago A Lozano-Calderon, MD, PhD principal investigator
Massachusetts General Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin 325mg and Enoxaparin 40Mg/0.4mL Prefilled Syringe in people with Sarcoma and Soft Tissue Sarcoma, run by Massachusetts General Hospital at 10 sites 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 0 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Venous thromboembolism (time frame: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively). 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 9 Oct 2026.