DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of Dalteparin as Prophylactic Treatment of DVT in Orthopedic Oncology Patients
The primary endpoint for safety monitoring is re-operation rate due to complications experienced by patients within the first 4 weeks after surgery.
4 weeks after surgery
Patrick Lin, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|