Clinical trial · Interventional
Dalteparin in Preventing DVT in Participants With Cancer
DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
NCT00525057CI-TRIAL-00049540completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This trial studies how well dalteparin works in preventing deep vein thrombosis (DVT) (blood clots) in participants with cancer. Dalteparin is a blood thinner that can treat blood clots and may prevent them from forming.
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 |
|---|---|---|---|
| Bone Sarcoma | Bone Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Femur Fracture | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Metastatic Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Pathologic Fracture | — | UNRESOLVED | — |
| Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalteparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (dalteparin)
- description
- Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
- interventionNames
- Drug: Dalteparin
Primary outcomes (1)
- measure
- Number of Participants With Post-operative Wound Complications
- timeFrame
- 4 weeks after surgery
- description
- Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma.
Secondary outcomes (2)
- measure
- Number of Participants With Occurrence of Venous Thromboembolism
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * GROUP A * Metastatic disease, myeloma, lymphoma. * Pathologic fracture or impending pathologic fracture of the femur. * Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty. * GROUP B * Primary sarcoma of bone or soft tissue of the lower extremity. * T2 tumor (\> 5 cm by \< 20 cm). * Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction. Exclusion Criteria: * Presence of DVT on pre-operative screening ultrasound study. * Massive tumor (\> 20 cm in greatest dimension). * Amputation of the affected leg as treatment of tumor. * Estimated blood loss \> 2 liters during surgery. * Surgical drain output \> 500 cc of bloody fluid during first 8 hours. * International normalized ratio (I.N.R.) \> 1.3 pre-operatively or \> 1.5 post-operatively. * Platelet count \< 100,000 either pre-operatively or post-operatively. * Indwelling post-operative epidural catheter for pain control. * History of underlying bleeding disorder, such as hemophilia. * History of adverse reaction to heparin such as heparin-induced thrombocytopenia. * Severe liver or renal insufficiency. * History of hypertensive or diabetic retinopathy. * History of gastro-intestinal bleeding within 12 months. * Treatment with warfarin, clopidogrel, aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), low molecular weight heparin (LMWH) or other anti-coagulants for conditions. * History of stroke. * Women of child bearing potential having a positive urine or serum pregnancy test (human chorionic gonadotropin \[hCG\]) at the time of pre-operative evaluation (within 7 days of surgery). * Women who are breastfeeding. * Hemoglobin \< 8.0 g/dL. * Platelet count \< 100,000/L. * Alanine aminotransferase \> 100 IU/L. * Aspartate aminotransferase \> 100 IU/L. * Direct bilirubin \> 0.5mg/dL. * Serum creatinine \> 2.0 mg/dL. * Patients taking COX-2 inhibitors. * Patients who have fragmented mechanical heart valves.
References
Publications (0)
Data not yet available
No reference posted for this study.