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Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

Phase 3
Conditions
Lung Cancer
Interventions
Drug: Nadroparin, long term
Registration Number
NCT01980849
Lead Sponsor
Shengqing Li
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
272
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Long term prophylaxisNadroparin, long termNadroparin, 0.4mL, subcutaneously, qid, given by long-term
Primary Outcome Measures
NameTimeMethod
Incidence of venous thromboembolism12 weeks
Secondary Outcome Measures
NameTimeMethod
Incidence of bleedingDuring 6 months

Trial Locations

Locations (23)

The Department of Pulmonary and Critical Care Medicine,Cancer Hospital

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Zhengzhou, Henan, China

The Department of Oncology,Henan University Affiliated Yihe Hospital

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Zhengzhou, Henan, China

The Department of Oncology,Cancer Hospital

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Baotou, Inner Mongolia, China

The Department of Oncology,Inner Mongolia Autonomous Region Hospital

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Hohhot, Inner Mongolia, China

The Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Jiaotong University

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Xi'an, Shaanxi, China

The Department of Pulmonary and Critical Care Medicine,Second People's Hospital

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Xi'an, Shaanxi, China

The Department of Oncology,Yan'an University Hospital

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Yan'an, Shaanxi, China

The Department of Oncology,Second Hospital of Shanxi Medical University

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Taiyuan, Shanxi, China

The Department of Pulmonary and Critical Care Medicine,First Affiliated Hospital of Medical University

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Urumqi, Xinjiang, China

The Department of Oncology,Northern Hospital

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Baotou, Inner Mongolia, China

The Department of Pulmonary and Critical Care Medicine, Tangdu Hospital

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Xi'an, Shaanxi, China

The Department of Oncology,First Affiliated Hospital of Jiaotong University

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Xi'an, Shaanxi, China

The Department of Pulmonary and Critical Care Medicine,Southwest Hospital

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Chongqing, Chongqing, China

The Department of Oncology,Ohtsubo Hospital

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Chongqing, Chongqing, China

The Department of Oncology,Southwest Hospital

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Chongqing, Chongqing, China

The Department of Oncology,Central Hospital

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Xinxiang, Henan, China

The Department of Oncology,Fuling Central Hospital

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Chongqing, Chongqing, China

The Department of Oncology,People's Hospital

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Chengdu, Sichuan, China

The Department of Pulmonary and Critical Care Medicine,Central Hospital

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Baoji, Shaanxi, China

The Department of Pulmonary and Critical Care Medicine,Medical University General Hospital cardiovascular and cerebrovascular disease hospital

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Yinchuan, Ningxia, China

The Department of Pulmonary and Critical Care Medicine, Xijing Hospital

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Xi'an, Shaanxi, China

The Department of Lung oncology,Tumor Hospital

🇨🇳

Chengdu, Sichuan, China

The Department of Oncology,First Affiliated Hospital of Medical University

🇨🇳

Urumqi, Xinjiang, China

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