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Nadroparin for the Initial Treatment of Pulmonary Thromboembolism (NATSPUTE)

Primary Purpose

Pulmonary Embolism, Thromboembolism, Vascular Diseases

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nadroparin
Unfractionated heparin(UFH)
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Heparin, Low molecular weight heparin, Safety, Efficacy, Cost effective

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Peking University First Hospital
  • Beijing General Hospital of the Air-force PLA
  • Beijing Naval General Hospital
  • Peking University People's Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing No 6 Hospital
  • Peking University Third Hospital
  • Beijing Hospital
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  • The First Affiliated Hospital Sun Yat-Sen University
  • Guangzhou Institute of Respiratory Disease，Guangzhou Medical University
  • The Third Affiliated Hospital, Sun Yat-Sen University
  • Shenzhen People's Hospital
  • The First Affiliated Hospital of Guangxi Medical University
  • The Second Affiliated Hospital of Hebei Medical University
  • Tangshan Worker's Hospital, Hebei Medical University
  • The Affiliated Hospital of Hubei Coal University
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan Union Hospital
  • Liaoning Angang Tiedong Hospital
  • The First Hospital of China Medical University
  • The General Hospital of Shenyang Military Command
  • The Affiliated Hospital of Shenyang Medical University
  • The Affiliated Hospital of Ningxia Medical University
  • Qilu Hospital Affiliated to Shandong University
  • The Affiliated Hospital of Medical College Jining
  • The Affiliated Hospital of Medical College Qingdao
  • Shandong Yantaishan Hospital
  • Shanghai Ruijin Hospital
  • Shanghai Changhai Hospital
  • Shanghai Pulmonary Hospital(8)
  • Shanxi Datong 5th Hospital
  • The First Affiliated Hospital of Shanxi Medical University
  • The Second Affiliated Hospital of Shanxi Medical University
  • Tianjin Thoracic Hospital
  • Tianjin Medical University General Hospital
  • Xinjiang People's Hospital
  • Sir Run Run Shaw Hospital, Affiliated with Zhejiang University
  • The First Affiliated Hospital of Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 2

Group 1

Arm Description

Low molecular weight heparin

Unfractionated heparin(UFH)

Outcomes

Primary Outcome Measures

Clinical and image(including V/Q scan and CTPA) improvement

Secondary Outcome Measures

Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia

Full Information

First Posted
November 20, 2008
Last Updated
November 21, 2008
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00796692
Brief Title
Nadroparin for the Initial Treatment of Pulmonary Thromboembolism
Acronym
NATSPUTE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Thromboembolism, Vascular Diseases, Thrombosis
Keywords
Heparin, Low molecular weight heparin, Safety, Efficacy, Cost effective

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Experimental
Arm Description
Low molecular weight heparin
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Unfractionated heparin(UFH)
Intervention Type
Drug
Intervention Name(s)
Nadroparin
Other Intervention Name(s)
Low moleculor weight hepatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin(UFH)
Other Intervention Name(s)
Standard Unfractionated heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical and image(including V/Q scan and CTPA) improvement
Time Frame
Time Frame: 14days
Secondary Outcome Measure Information:
Title
Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen WANG, Prof
Organizational Affiliation
Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing General Hospital of the Air-force PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Beijing Naval General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing No 6 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital Sun Yat-Sen University
City
Guangzhou
State/Province
Guandong
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou Institute of Respiratory Disease，Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530027
Country
China
Facility Name
The Second Affiliated Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Tangshan Worker's Hospital, Hebei Medical University
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The Affiliated Hospital of Hubei Coal University
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Liaoning Angang Tiedong Hospital
City
Anshan
State/Province
Liaoning
ZIP/Postal Code
114002
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
The General Hospital of Shenyang Military Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
The Affiliated Hospital of Shenyang Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110024
Country
China
Facility Name
The Affiliated Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
Qilu Hospital Affiliated to Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The Affiliated Hospital of Medical College Jining
City
Jining
State/Province
Shandong
ZIP/Postal Code
272029
Country
China
Facility Name
The Affiliated Hospital of Medical College Qingdao
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Shandong Yantaishan Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264001
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanghai Pulmonary Hospital(8)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Shanxi Datong 5th Hospital
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037006
Country
China
Facility Name
The First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
The Second Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Tianjin Thoracic Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300051
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Xinjiang People's Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Sir Run Run Shaw Hospital, Affiliated with Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
18261355
Citation
Pang BS, Wang C, Lu Y, Yang YH, Xing GH, Mao YL, Huang XX, Zhai ZG. [Changes of blood coagulative and fibrinolytic system and function of pulmonary vascular endothelium after therapy in patients with acute pulmonary thromboembolism]. Zhonghua Yi Xue Za Zhi. 2007 Nov 20;87(43):3074-8. Chinese.
Results Reference
background
PubMed Identifier
17716753
Citation
Zhu L, Yang Y, Wu Y, Zhai Z, Wang C. Value of right ventricular dysfunction for prognosis in pulmonary embolism. Int J Cardiol. 2008 Jun 23;127(1):40-5. doi: 10.1016/j.ijcard.2007.06.093. Epub 2007 Aug 22.
Results Reference
background
PubMed Identifier
17705052
Citation
Zhu L, Wang C, Yang Y, Wu Y, Zhai Z, Dai H, Pang B, Tong Z. Value of transthoracic echocardiography in therapy regimens evaluation in pulmonary embolism. J Thromb Thrombolysis. 2008 Dec;26(3):251-6. doi: 10.1007/s11239-007-0087-8. Epub 2007 Aug 21.
Results Reference
background
PubMed Identifier
17550736
Citation
Liu CP, Lu WX, Liu WG, Chen HW, Wang C. [The low molecular weight heparin on rat pulmonary surfactant associated protein A of acute pulmonary embolism]. Zhonghua Yi Xue Za Zhi. 2007 Mar 6;87(9):634-6. Chinese.
Results Reference
background
PubMed Identifier
17254482
Citation
Zhu L, Yang YH, Wu YF, Zhai ZG, Wang C; National Project of the Diagnosis and Treatment Strategies for Pulmonary Thromboembolism investigators. Value of transthoracic echocardiography combined with cardiac troponin I in risk stratification in acute pulmonary thromboembolism. Chin Med J (Engl). 2007 Jan 5;120(1):17-21.
Results Reference
background
PubMed Identifier
15634380
Citation
Sun KK, Wang C, Guli XT, Luo Q. [Risk factors and clinical features of deep venous thrombosis: a report of 388 cases]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Nov;27(11):727-30. Chinese.
Results Reference
background
PubMed Identifier
15266820
Citation
Zhai ZG, Wang C, Liu YM, Qin ZQ. [Comparison of unfractionated heparin and low molecular weight heparin in pulmonary thromboembolism: meta-analysis]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2004 Jun;26(3):221-6. Chinese.
Results Reference
background
PubMed Identifier
15256085
Citation
Pang BS, Wang C, Luo Q, Zhang LM, Zhu M, Mao YL, Huang XX, Guo WJ. [Study of the function of coagulation, fibrinolysis and pulmonary vascular endothelium before and after experimental pulmonary thromboembolism in rabbits]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Jun;27(6):381-4. Chinese.
Results Reference
background
PubMed Identifier
14989818
Citation
Zai ZG, Wang C. [Advances in the study of pulmonary thromboembolism]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Jan;27(1):14-8. No abstract available. Chinese.
Results Reference
background
PubMed Identifier
14720434
Citation
Qin ZQ, Wang C. [Comparison of thrombolysis and anticoagulation in pulmonary thromboembolism: a meta-analysis]. Zhonghua Jie He He Hu Xi Za Zhi. 2003 Dec;26(12):772-5. Chinese.
Results Reference
background

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Nadroparin for the Initial Treatment of Pulmonary Thromboembolism

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