DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study | RxWiki

DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

Overview[ - collapse ][ - ]

Purpose	The primary endpoint of the study would be to determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopaedic oncology patients. Specifically, the goal of the study is to determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity. The study would help establish specific parameters for use of dalteparin in complex orthopaedic oncology patients. Not all patients would be appropriate for this medication, particularly those with massive hemorrhage during surgery and those with underlying coagulopathies. It is likely that patients requiring limited tumor excision, particularly those with metastatic carcinoma, would be ideal candidates for dalteparin therapy. Patients who require radical resections of tumor may need stricter guidelines for the safe use of the medication, since the potential for post-operative bleeding may be greater.
Condition	Bone Cancer
Intervention	Drug: Dalteparin
Phase	N/A
Sponsor	M.D. Anderson Cancer Center
Responsible Party	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier	NCT00525057
First Received	September 4, 2007
Last Updated	September 11, 2013
Last verified	September 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 4, 2007
Last Updated Date	September 11, 2013
Start Date	July 2006
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Safety of Dalteparin as Prophylactic Treatment of DVT in Orthopedic Oncology Patients [Time Frame: 4 weeks after surgery] [Designated as safety issue: Yes]The primary endpoint for safety monitoring is re-operation rate due to complications experienced by patients within the first 4 weeks after surgery.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
Official Title	DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
Brief Summary	The primary endpoint of the study would be to determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopaedic oncology patients. Specifically, the goal of the study is to determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity. The study would help establish specific parameters for use of dalteparin in complex orthopaedic oncology patients. Not all patients would be appropriate for this medication, particularly those with massive hemorrhage during surgery and those with underlying coagulopathies. It is likely that patients requiring limited tumor excision, particularly those with metastatic carcinoma, would be ideal candidates for dalteparin therapy. Patients who require radical resections of tumor may need stricter guidelines for the safe use of the medication, since the potential for post-operative bleeding may be greater.
Detailed Description	Dalteparin is an FDA-approved blood thinner (prevents clots by thinning the blood). Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history, physical exam and a Doppler ultrasound of both legs. The Doppler ultrasound test uses sound waves to check the veins of your legs for the presence of any pre-existing deep venous thrombosis (blood clots). You will also have blood drawn for routine blood tests (about 2 tablespoons). Women who are able to have children must have negative blood or urine pregnancy test before taking part in the study. You will be proceed with your scheduled surgery regardless of whether or not you take part in this study. During surgery, you will have TED hose and a mechanical compression stocking put on the leg that will not be having surgery. TED stands for thromboembolic disease, which means "blood clots". TED hose are special stockings that are worn on the legs to prevent blood from clotting. Mechanical compression stockings are air filled stockings that inflate and deflate intermittently. You will then have TED hose and mechanical compression stockings applied to the leg that had surgery in the recovery room. You will be monitored by daily physical exams for any signs of deep venous thrombosis (DVT - blood clot) DVT in the veins of the legs. Within 12-24 hours following surgery to remove the bone tumor, you will begin treatment with dalteparin. You will receive an injection of dalteparin once every day by an injection given deep under the skin. The injection site will be varied each day and will be given daily until your are discharged from the hospital (about 7-10 days). You will also have blood drawn for routine blood tests following surgery (about 2 tablespoons). A follow-up Doppler ultrasound study of the leg that had surgery will be done before discharge from the hospital. Participants who experience any complications following surgery, including a DVT, will be immediately treated by standard of care procedures. Your participation in this study will be over at the time of your discharge from the hospital. This is an investigational study. Dalteparin is an FDA-approved blood thinner. Its use together with TED hose and mechanical compression stockings in this study is experimental. The TED hose and mechanical compression stockings used in the study is considered standard of care. Up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Bone Cancer
Intervention	Drug: Dalteparin 5000 units subcutaneous injection once daily, for 7 - 10 days. Other Names: Fragmin
Study Arm (s)	Experimental: Group A: Metastatic disease, myeloma, lymphoma - Dalteparin 5000 units subcutaneous injection once daily, for 7 - 10 days. Experimental: Group B: Primary sarcoma of bone or soft tissue of the lower extremity - Dalteparin 5000 units subcutaneous injection once daily, for 7 - 10 days.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	70
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	July 2015
Eligibility Criteria	Inclusion Criteria: 1. Group A: Metastatic disease, myeloma, lymphoma; 2. Group A: Pathologic fracture or impending pathologic fracture of the femur; 3. Group A: Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty. 4. Group B: Primary sarcoma of bone or soft tissue of the lower extremity. 5. Group B: T2 tu;mor (>5 cm buty < 20 cm); 6. Group B: Radical resection of tumor, which may necessitate major bone or soft tissue reconstruction. Exclusion Criteria: 1. Presence of DVT on pre-operative screening ultrasound study 2. Massive tumor (> 20 cm in greatest dimension) 3. Amputation of the affected leg as treatment of tumor 4. Estimated blood loss > 2 liters during surgery 5. Surgical drain output > 500 cc of bloody fluid during first 8 hours 6. I.N.R. > 1.3 pre-operatively or > 1.5 post-operatively 7. Platelet count < 100,000 either pre-operatively or post-operatively 8. Indwelling post-operative epidural catheter for pain control 9. Age < 30 years 10. History of underlying bleeding disorder, such as hemophilia 11. History of adverse reaction to heparin such as heparin-induced thrombocytopenia 12. Severe liver or renal insufficiency 13. History of hypertensive or diabetic retinopathy 14. History of gastro-intestinal bleeding within 12 months 15. Treatment with warfarin, clopidogrel, aspirin, NSAIDs, LMWH or other anti-coagulants for conditions 16. History of stroke 17. Women of child bearing potential having a positive urine or serum pregnancy test (hCG) at the time of pre-operative evaluation (within 7 days of surgery) 18. Women who are breastfeeding 19. Hemoglobin < 8.0 g/dL 20. Platelet count < 100,000 /L 21. Alanine aminotransferase > 100 IU/L 22. Aspartate aminotransferase > 100 IU/L 23. Direct bilirubin > 0.5mg/dL 24. Serum creatinine > 2.0 mg/dL 25. Patients taking COX-2 inhibitors 26. Patients who have fragmented mechanical heart valves
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00525057
Other Study ID Numbers	2004-0743
Has Data Monitoring Committee	No
Information Provided By	M.D. Anderson Cancer Center
Study Sponsor	M.D. Anderson Cancer Center
Collaborators	Pfizer
Investigators	Principal Investigator: Patrick Lin, MD M.D. Anderson Cancer Center
Verification Date	September 2013

Locations[ + expand ][ + ]