|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Pfizer |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00525057 |
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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study |
| Estimated Enrollment: | 70 |
| Study Start Date: | July 2006 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Dalteparin Group A: Metastatic disease, myeloma, lymphoma
|
Drug: Dalteparin
5000 units subcutaneous injection once daily
|
|
2: Experimental
Dalteparin Group B: Primary sarcoma of bone or soft tissue of the lower extremity.
|
Drug: Dalteparin
5000 units subcutaneous injection once daily
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Patrick Lin, MD | 713-745-4117 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Patrick Lin, MD | |
| Principal Investigator: | Patrick Lin, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Patrick Lin, MD/Associate Professor ) |
| Study ID Numbers: | 2004-0743 |
| Study First Received: | September 4, 2007 |
| Last Updated: | September 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00525057 |
| Health Authority: | United States: Institutional Review Board |
|
Bone Cancer Orthopaedics DVT Prophylaxis |
Dalteparin Fragmin Deep Venous Thrombosis |
|
Musculoskeletal Diseases Bone Neoplasms Dalteparin Bone neoplasms |
Venous Thrombosis Bone Diseases Thrombosis |
|
Fibrin Modulating Agents Neoplasms Anticoagulants Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |
