Dalteparin in Preventing DVT in Participants With Cancer
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|ClinicalTrials.gov Identifier: NCT00525057|
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : June 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bone Sarcoma Femur Fracture Lymphoma Metastatic Neoplasm Pathologic Fracture Plasma Cell Myeloma Soft Tissue Sarcoma||Drug: Dalteparin||Not Applicable|
I. To determine the safety of dalteparin as prophylaxis against deep venous thrombosis (DVT) in orthopedic oncology patients.
II. To determine whether there are significantly increased bleeding complications at the surgical site after major oncologic operations in the lower extremity.
Participants receive dalteparin subcutaneously (SC) once daily (QD) starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DVT Prophylaxis in Orthopaedic Oncology Patients - A Safety Study|
|Actual Study Start Date :||July 7, 2006|
|Actual Primary Completion Date :||June 19, 2020|
|Actual Study Completion Date :||June 19, 2020|
Experimental: Treatment (dalteparin)
Participants receive dalteparin SC QD starting 12-24 hours after surgery on post-operative day 1 until hospital discharge, about 7-10 days.
- Incidence of adverse events [ Time Frame: Up to 4 weeks after surgery ]Knowledge gained from the treatment of these participants will be used to design larger, more definitive studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525057
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Patrick Lin||M.D. Anderson Cancer Center|