Lung Cancer
Conditions
Keywords
Nadroparin, venous thromboembolism prophylaxis
Brief summary
To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.
Detailed description
This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.
Interventions
DRUGNadroparin, long term
DRUGNadroparin: short-term
Sponsors
Shengqing Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients * Performance status score ≤ 2 * Chest CT with measurable lesions
Exclusion criteria
* Examination revealed any part of venous thromboembolism * Chemotherapy regimens containing bevacizumab or Endostar * Severe coagulopathy * Active bleeding within two weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of venous thromboembolism | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding | During 6 months |
Other
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
Countries
China
Contacts
Primary ContactShengqing Li, MD, PhD
Outcome results
None listed