Lymphoma Clinical Trial
Official title:
DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
Verified date | December 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | June 19, 2020 |
Est. primary completion date | June 19, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Post-operative Wound Complications | Our primary outcome was the incidence of post-surgical complications, to include wound dehiscence, infection, and seroma. | 4 weeks after surgery | |
Secondary | Number of Participants With Occurrence of Venous Thromboembolism | A secondary outcome was the occurrence of venous thrombolembolism in the post-operative period, to include both deep venous thrombosis in the lower extremity as well as pulmonary embolism. | 4 weeks after surgery | |
Secondary | Post-Operative Blood Transfusion | The volume of packed red blood cell transfusion in the post-operative period | 4 weeks after surgery |
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