The Effect of Low Molecular Weight Heparin on Survival in Patients With Advanced Colorectal Cancer (LMWHCR)
The purpose of this study is to investigate the efficacy and safety of low-molecular-weight heparin in the prevention of venous thromboembolism and improvement of disease-free survival in patients after surgery for colorectal cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of The Effect of Low Molecular Weight Heparin on Survival in Patients With Advanced Colorectal Cancer|
- the rate of venous thromboembolism, the rate of major and minor bleeding [ Time Frame: 1 month after the operation ] [ Designated as safety issue: Yes ]
Venous thromboembolism: symptomatic deep vein thrombosis, pulmonary embolism. Major bleeding: an overt bleeding which was fatal, occurred in a critical organ.
Minor bleeding: any overt bleeding that required a medical intervention and did not meet any of the criteria for major bleeding.
- 3 years disease-free survival [ Time Frame: 3 years after operation of colorectal cancer ] [ Designated as safety issue: Yes ]PFS will be defined as the period from the first day of CRC resection to local or distant(i.e. metastasis) disease recurrence or death.
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]OS will be calculated from randomization to death from any cause or the date of the last follow-up, at which point the data will be censored.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: ARM A
Low-molecular-weight heparin (nadroparin 5000IU)was injected by subcutaneous injections for 7 days after surgery daily.
nadroparin 5000IU/day was injected by subcutaneous injections for 7 days after surgery.
Other Name: one kind of low molecular weight heparin
Placebo Comparator: ARM B
Placebo (NS) was injected by subcutaneous injections for 7 days after surgery daily.
A consecutive patients after surgery for colorectal cancer from ZhongShan hospital, Fudan university were enrolled and randomly assigned to taking low-molecular-weight or placebo. Post-operative formation of venous thromboembolism, major and minor bleeding, disease-free survival were compared.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972490
|Contact: jianmin Xu, MDemail@example.com|
|Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200000|
|Contact: jianmin xu, MD 008613501984869 firstname.lastname@example.org|