Dalteparin in Preventing DVT in Participants With Cancer

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Pfizer
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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.