DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00525057
First received: September 4, 2007
Last updated: September 11, 2014
Last verified: September 2014
  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 Intervention
Bone Cancer
Drug: Dalteparin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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.


Estimated Enrollment: 70
Study Start Date: July 2006
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A:
Metastatic disease, myeloma, lymphoma - Dalteparin 5000 units subcutaneous injection once daily, for 7 - 10 days.
Drug: Dalteparin
5000 units subcutaneous injection once daily, for 7 - 10 days.
Other Name: Fragmin
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.
Drug: Dalteparin
5000 units subcutaneous injection once daily, for 7 - 10 days.
Other Name: Fragmin

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525057

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Pfizer
Investigators
Principal Investigator: Patrick Lin, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00525057     History of Changes
Other Study ID Numbers: 2004-0743, NCI-2010-00755
Study First Received: September 4, 2007
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Bone Neoplasms
Osteosarcoma
Bone Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Sarcoma
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014