Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients
The goal of this clinical research study is to learn if dalteparin can lower the risk of VTE occurring in the legs and lungs. This will be tested in patients with pancreatic cancer who are going to receive chemotherapy. Some patients will receive dalteparin and some will receive no study drug.
The safety of dalteparin will also be studied.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial of Dalteparin for Primary Venous Thromboembolism (VTE) Prophylaxis in Pancreatic Cancer Patients Undergoing Chemotherapy Treatment.|
- Venous Thromboembolic Events (VTE) Rate [ Time Frame: 16 weeks of treatment ] [ Designated as safety issue: No ]Venous thromboembolism (VTE) rate defined by both symptomatic and asymptomatic VTE which includes deep venous thrombosis (DVT) and pulmonary embolism (PE).
|Study Start Date:||April 2010|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Group 1: Dalteparin
Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
5000 units subcutaneous, by injection under the skin, daily for 16 weeks
Other Name: Fragmin
No Intervention: Group 2: Control
No study drug.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00966277
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Saroj Vadhan-Raj, MD||UT MD Anderson Cancer Center|