Nadroparin for the Initial Treatment of Pulmonary Thromboembolism
- Conditions
- Pulmonary EmbolismThromboembolismVascular DiseasesThrombosis
- Interventions
- Drug: Unfractionated heparin(UFH)
- Registration Number
- NCT00796692
- Lead Sponsor
- Beijing Chao Yang Hospital
- Brief Summary
Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population. The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.
- Detailed Description
Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be so in patients with pulmonary thromboembolism (PTE). Only limited data are available on the evaluation of body weight adjusted LWMH and standard UFH for the initial treatment of PTE in Chinese population.
The aim of this study is to determine whether body weight-adjusted, subcutaneous Nadroparin is as effective and safe as UFH for treatment of patients with objectively documented PTE.
An open-label, adjudicator-blinded, randomized controlled trial of patients with symptomatic non-massive PTE from 37 major hospitals in China is conducted . Intravenous UFH was administered received an initial bolus dose of 80 IU/kg, followed by a continuous infusion at an initial rate of 18 IU/kg /hour. The dose was subsequently adjusted by activated partial thromboplastin time (APTT) monitoring. LMWH (nadroparin) was administered subcutaneously at a dose of 86 anti-factor Xa IU/kg every 12 hours.
Both treatments were overlapped with at least 3 months of warfarin therapy. Main outcome measures were combined end point of clinical effect, image improvement,Recurrent venous thromboembolism(VTE), major bleeding, and death within 14 days and 3 months of randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
- 18 to 75 years of age
- Symptomatic non massive PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
- Haemodynamic stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan,and normal right ventricular function
- Symptoms within 15 days
- Written informed consent obtained before randomization.
- Unfractioned heparin anticoagulation for more than 36 hours prior enrollment,
- Massive PTE or sub-massive PTE requiring thrombolytic therapy or pulmonary embolectomy; Active bleeding or disorders contraindicating anticoagulant therapy
- Chronic thromboembolism pulmonary hypertension(CTEPH) without evidence of recent episode; Severe hepatic or renal failure
- Allergy to heparin, other components of Tinzaparin or acenocoumarol,
- Pregnant status;a life expectancy of less than 3 months;
- Previous thrombocytopenia induced by heparin
- Thrombocytopenia < 100000/mm3,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Unfractionated heparin(UFH) Unfractionated heparin(UFH) Group 2 Nadroparin Low molecular weight heparin
- Primary Outcome Measures
Name Time Method Clinical and image(including V/Q scan and CTPA) improvement Time Frame: 14days
- Secondary Outcome Measures
Name Time Method Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia 3 months
Trial Locations
- Locations (39)
The Second Affiliated Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
The Affiliated Hospital of Medical College Jining
π¨π³Jining, Shandong, China
The Affiliated Hospital of Shenyang Medical University
π¨π³Shenyang, Liaoning, China
Wuhan Union Hospital
π¨π³Wuhan, Hubei, China
The Affiliated Hospital of Ningxia Medical University
π¨π³Yinchuan, Ningxia, China
Shanghai Changhai Hospital
π¨π³Shanghai, Shanghai, China
Tianjin Thoracic Hospital
π¨π³Tianjin, Tianjin, China
Tianjin Medical University General Hospital
π¨π³Tianjin, Tianjin, China
Sir Run Run Shaw Hospital, Affiliated with Zhejiang University
π¨π³Hangzhou, Zhejiang, China
Tangshan Worker's Hospital, Hebei Medical University
π¨π³Tangshan, Hebei, China
Liaoning Angang Tiedong Hospital
π¨π³Anshan, Liaoning, China
The Affiliated Hospital of Medical College Qingdao
π¨π³Qingdao, Shandong, China
Shanxi Datong 5th Hospital
π¨π³Datong, Shanxi, China
Beijing General Hospital of the Air-force PLA
π¨π³Beijing, Beijing, China
Beijing Naval General Hospital
π¨π³Beijing, Beijing, China
Guangzhou Institute of Respiratory DiseaseοΌGuangzhou Medical University
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital Sun Yat-Sen University
π¨π³Guangzhou, Guandong, China
The Affiliated Hospital of Hubei Coal University
π¨π³Tangshan, Hebei, China
Peking University Third Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
The General Hospital of Shenyang Military Command
π¨π³Shenyang, Liaoning, China
Qilu Hospital Affiliated to Shandong University
π¨π³Jinan, Shandong, China
Beijing Hospital
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
The Second Affiliated Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Shanghai Pulmonary Hospital(8)
π¨π³Shanghai, Shanghai, China
Xinjiang People's Hospital
π¨π³Urumqi, Xinjiang, China
Beijing No 6 Hospital
π¨π³Beijing, Beijing, China
Shenzhen People's Hospital
π¨π³Shenzhen, Guangdong, China
Beijing Friendship Hospital, Capital Medical University
π¨π³Beijing, Beijing, China
The First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Peking University People's Hospital
π¨π³Beijing, Beijing, China
The Third Affiliated Hospital, Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
The First Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Shanghai Ruijin Hospital
π¨π³Shanghai, Shanghai, China
Shandong Yantaishan Hospital
π¨π³Yantai, Shandong, China
The First Affiliated Hospital of Wenzhou Medical College
π¨π³Wenzhou, Zhejiang, China
Peking University First Hospital
π¨π³Beijing, Beijing, China