Nadroparin for the Initial Treatment of Pulmonary Thromboembolism (NATSPUTE)

November 21, 2008 updated by: Beijing Chao Yang Hospital

Efficacy and Safety of Body Weight Adjusted Nadroparin vs Standard Unfractionated Heparin for the Initial Treatment of Pulmonary Thromboembolism：a Multi-Centre, Randomised Controlled Trial in China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100083
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 100036
        • Beijing General Hospital of the Air-force PLA
      • Beijing, Beijing, China, 100037
        • Beijing Naval General Hospital
      • Beijing, Beijing, China, 100083
        • Beijing No 6 Hospital
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    • Guandong
      • Guangzhou, Guandong, China, 510120
        • The First Affiliated Hospital Sun Yat-Sen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Disease，Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530027
        • The First Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The Second Affiliated Hospital of Hebei Medical University
      • Tangshan, Hebei, China, 063000
        • Tangshan Worker's Hospital, Hebei Medical University
      • Tangshan, Hebei, China, 063000
        • The Affiliated Hospital of Hubei Coal University
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
    • Liaoning
      • Anshan, Liaoning, China, 114002
        • Liaoning Angang Tiedong Hospital
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110016
        • The General Hospital of Shenyang Military Command
      • Shenyang, Liaoning, China, 110024
        • The Affiliated Hospital of Shenyang Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • The Affiliated Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital Affiliated to Shandong University
      • Jining, Shandong, China, 272029
        • The Affiliated Hospital of Medical College Jining
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Medical College Qingdao
      • Yantai, Shandong, China, 264001
        • Shandong Yantaishan Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Ruijin Hospital
      • Shanghai, Shanghai, China, 200433
        • Shanghai Changhai Hospital
      • Shanghai, Shanghai, China, 200433
        • Shanghai Pulmonary Hospital(8)
    • Shanxi
      • Datong, Shanxi, China, 037006
        • Shanxi Datong 5th Hospital
      • Taiyuan, Shanxi, China, 030001
        • The Second Affiliated Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China, 030001
        • The First Affiliated Hospital of Shanxi Medical University
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin, China, 300051
        • Tianjin Thoracic Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Xinjiang People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Affiliated with Zhejiang University
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Low molecular weight heparin
Drug: Nadroparin
LMWH is given with a weight adjusted dose of 86 international anti-factor Xa units of nadroparin (Fraxiparine) per kilogram of body weight(86 anti-factor Xa IU/kg) subcutaneously every 12 hours,which will be used at least 5-7 days.
Other Names:
  • Low moleculor weight hepatin
Active Comparator: Group 1
Unfractionated heparin(UFH)
Drug: Unfractionated heparin(UFH)
UFH is received with an initial bolus dose of 80 IU per kilogram, followed by a continuous intravenous infusion at an initial rate of 18 IU per kilogram per hour. The dose is subsequently adjusted so that the activated partial thromboplastin time (APTT) would be 1.5 to 2.5 times the control value in normal subjects. The tests are performed 4 hours after the start of treatment, whenever a sub-therapeutic APTT had been measured after a dose adjustment, and otherwise daily.UFH will be used at least 5-7 days.
Other Names:
  • Standard Unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical and image(including V/Q scan and CTPA) improvement
Time Frame: Time Frame: 14days
Time Frame: 14days

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Investigators

  • Principal Investigator: Chen WANG, Prof, Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 24, 2008

Last Update Submitted That Met QC Criteria

November 21, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004BA703B07
  • 2001BA703B13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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