Clinical trial · Interventional
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anticoagulant-induced Bleeding | — | UNRESOLVED | — |
| Bone Metastases | — | UNRESOLVED | — |
| Bone Sarcoma | Bone Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Hematoma | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin 325mg | Drug | Aspirin | ALIAS |
| Enoxaparin 40Mg/0.4mL Prefilled Syringe | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- LMWH for Soft Tissue Sarcoma
- description
- 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
- interventionNames
- Drug: Enoxaparin 40Mg/0.4mL Prefilled Syringe
- type
- EXPERIMENTAL
- label
- ASA for Soft Tissue Sarcoma
- description
- Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis
- interventionNames
- Drug: Aspirin 325mg
- type
- EXPERIMENTAL
- label
- LMWH for Primary Bone Tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available