Nadroparin for the Initial Treatment of Pulmonary Thromboembolism
NATSPUTE
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
2 other identifiers
interventional
274
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2002
Longer than P75 for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedNovember 24, 2008
November 1, 2008
3.7 years
November 20, 2008
November 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical and image(including V/Q scan and CTPA) improvement
Time Frame: 14days
Secondary Outcomes (1)
Recurrent venous thromboembolism(VTE), major bleeding death Heparin-induced thrombocytopenia
3 months
Study Arms (2)
Group 2
EXPERIMENTALLow molecular weight heparin
Group 1
ACTIVE COMPARATORUnfractionated heparin(UFH)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing General Hospital of the Air-force PLA
Beijing, Beijing Municipality, 100036, China
Beijing Naval General Hospital
Beijing, Beijing Municipality, 100037, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing No 6 Hospital
Beijing, Beijing Municipality, 100083, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100083, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital Sun Yat-Sen University
Guangzhou, Guandong, 510120, China
Guangzhou Institute of Respiratory Disease，Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530027, China
The Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Tangshan Worker's Hospital, Hebei Medical University
Tangshan, Hebei, 063000, China
The Affiliated Hospital of Hubei Coal University
Tangshan, Hebei, 063000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Liaoning Angang Tiedong Hospital
Anshan, Liaoning, 114002, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The General Hospital of Shenyang Military Command
Shenyang, Liaoning, 110016, China
The Affiliated Hospital of Shenyang Medical University
Shenyang, Liaoning, 110024, China
The Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Qilu Hospital Affiliated to Shandong University
Jinan, Shandong, 250012, China
The Affiliated Hospital of Medical College Jining
Jining, Shandong, 272029, China
The Affiliated Hospital of Medical College Qingdao
Qingdao, Shandong, 266003, China
Shandong Yantaishan Hospital
Yantai, Shandong, 264001, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Shanghai Pulmonary Hospital(8)
Shanghai, Shanghai Municipality, 200433, China
Shanxi Datong 5th Hospital
Datong, Shanxi, 037006, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Tianjin Thoracic Hospital
Tianjin, Tianjin Municipality, 300051, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Xinjiang People's Hospital
Ürümqi, Xinjiang, 830001, China
Sir Run Run Shaw Hospital, Affiliated with Zhejiang University
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
Related Publications (10)
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.
PMID: 18261355BACKGROUNDZhu 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.
PMID: 17716753BACKGROUNDZhu 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.
PMID: 17705052BACKGROUNDLiu 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.
PMID: 17550736BACKGROUNDZhu 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.
PMID: 17254482BACKGROUNDSun 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.
PMID: 15634380BACKGROUNDZhai 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.
PMID: 15266820BACKGROUNDPang 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.
PMID: 15256085BACKGROUNDZai 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.
PMID: 14989818BACKGROUNDQin 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.
PMID: 14720434BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen WANG, Prof
Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 24, 2008
Study Start
June 1, 2002
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
November 24, 2008
Record last verified: 2008-11