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DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study


N/A
30 Years
N/A
Open (Enrolling)
Both
Bone Cancer

Thank you

Trial Information

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
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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Dalteparin as Prophylactic Treatment of DVT in Orthopedic Oncology Patients

Outcome Description:

The primary endpoint for safety monitoring is re-operation rate due to complications experienced by patients within the first 4 weeks after surgery.

Outcome Time Frame:

4 weeks after surgery

Safety Issue:

Yes

Principal Investigator

Patrick Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2004-0743

NCT ID:

NCT00525057

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Bone Cancer
  • Bone Cancer
  • Orthopaedic Oncology
  • Orthopaedics
  • Myeloma
  • Lymphoma
  • Deep Venous Thrombosis
  • DVT Prophylaxis
  • Thromboembolic disease
  • Blood clots
  • Dalteparin
  • Fragmin
  • Surgery
  • Bone Tumor
  • Tumor of soft tissue
  • Lower extremity
  • Leg
  • TED hose
  • Mechanical compression stocking
  • Bone Neoplasms
  • Osteosarcoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030