12-h and 2-h Urokinase Regimes of Pulmonary Thromboembolism in China

NCT00799968 | Completed Phase 4 DMC

• 1 other identifier: 2004BA703B07-UK
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 31

Brief Summary

Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether the infusion time can be reduced further. The aim of this study was to investigate the efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h regime in selected patients with PTE in Chinese population.

Conditions

Pulmonary Embolism; Thromboembolism

Keywords

Thrombolytic therapy; Urokinase; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score.

  14d

Secondary Outcomes (1)

• The incidence of major or minor bleeding, death rate, and PTE recurrence at 14d after treatment.

  14d

Study Arms (2)

Group 1

ACTIVE COMPARATOR

UK-12h group

Drug: Urokinase

Group 2

EXPERIMENTAL

UK-2h group

Drug: Urokinase

Interventions

Urokinase DRUG

UK,bolus 4 400 U/kg followed by intravenous 2 200 U/kg•h for 12 hours

Also known as: Urokinase,thrombolytic agent

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by CTPA.
• massive PTE patients with haemodynamic instability and/or cardiogenic shock
• Anatomic obstruction more than 2 lobes on CTPA and/or defect more than 7 segments on V/Q scan with evidence of right ventricular dysfunction (RVD) and pulmonary hypertension on echocardiography
• Symptoms within 15 days
• Written informed consent was obtained from all the patients before randomization

You may not qualify if:

• Received parenteral heparin for more than 72 hours
• Known allergic to urokinase
• Thrombolytic contraindications such as:
• active bleeding or spontaneous intracranial hemorrhage;
• major surgery, organ biopsy or recent puncture of a non-compressible vessel less than 10 days;
• cerebral arterial thrombosis within 2 months;
• gastro-intestinal bleeding within 10 days;
• major trauma within the past 15 days;
• neurosurgery or ophthalmologic operation with 30 days;
• uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg);
• recent external cardiac resuscitation manoeuvres;
• platelet count \< 100 000/mm3 at admission;
• pregnancy, puerperium or lactation with 2 weeks;
• infectious pericarditis or endocarditis;
• severe hepatic and kidney dysfunction;

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (31)

Beijing Chaoyang Hospital, Capital University of Medical Sciences

Beijing, Beijing Municipality, 100020, China

Location

Beijing General Hospital of the Air-force PLA

Beijing, Beijing Municipality, 100036, China

Location

Beijing Fu Xing Hospital, Capital Medical University

Beijing, Beijing Municipality, 100037, China

Location

Beijing Naval General Hospital

Beijing, Beijing Municipality, 100037, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Location

The First Affiliated Hospital Sun Yat-Sen University

Guangzhou, Guandong, 510120, China

Location

Guangzhou Institute of Respiratory Disease，Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530027, China

Location

The Second Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Tangshan Worker's Hospital, Hebei Medical University

Tangshan, Hebei, 063000, China

Location

The Affiliated Hospital of Hubei Coal University

Tangshan, Hebei, 063000, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

The General Hospital of Shenyang Military Command

Shenyang, Liaoning, 110016, China

Location

Qilu Hospital Affiliated to Shandong University

Jinan, Shandong, 250012, China

Location

The Affiliated Hospital of Medical College Qingdao

Qingdao, Shandong, 266003, China

Location

Shangdong Yantaishan Hospital

Yantai, Shandong, China

Location

The First Affiliated Hospital of Jining Medical College

Jinan, Shangdong, China

Location

The First Affiliated Hospital of Qingdao University CHENG Zhao-zhong

Qingdao, Shangdong, China

Location

The Fifth People's Hospital of Datong in ShanxiWANG;

Datong, Shanxi, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Tianjin Thoracic Hospital

Tianjin, Tianjin Municipality, 300051, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Xinjiang People's Hospital

Ürümqi, Xinjiang, 830001, China

Location

Sir Run Run Shaw Hospital, Affiliated with Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (15)

• 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: 18261355 BACKGROUND

• 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.

  PMID: 17716753 BACKGROUND

• Liu Y, Wang C, Yang Y, Hou X, Wang J. Pro-urokinase up-regulates the expression of urokinase-type plasminogen activator (u-PA) in human pulmonary arterial endothelial cells. Thromb Res. 2008;121(4):485-91. doi: 10.1016/j.thromres.2007.05.021. Epub 2007 Jul 20.

  PMID: 17640719 BACKGROUND

• 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.

  PMID: 17705052 BACKGROUND

• 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.

  PMID: 17254482 BACKGROUND

• Zhai ZG, Wang C, Yang YH, Pang BS, Xiao B, Liu YM, Mao YL, Weng XZ. [Relationship between polymorphisms of plasminogen activator inhibitor-1 promoter gene and pulmonary thromboembolism in Chinese Han population]. Zhonghua Yi Xue Za Zhi. 2006 May 23;86(19):1313-7. Chinese.

  PMID: 16796899 BACKGROUND

• Liu CP, Zhang YJ, Lu WX, Ji YQ, Zhang WH, Wang C. [The change of pulmonary surfactant associated protein A in acute pulmonary embolism]. Zhonghua Jie He He Hu Xi Za Zhi. 2005 Sep;28(9):600-3. Chinese.

  PMID: 16207426 BACKGROUND

• Ren H, Su PX, Zhang CJ, Gu S, Ma GT, Zhang H, Wang C. [Surgical treatment of chronic pulmonary thromboembolism]. Zhonghua Wai Ke Za Zhi. 2005 Mar 15;43(6):345-7. Chinese.

  PMID: 15854334 BACKGROUND

• Wang C, Cheng XS, Zhong NS. [Promoting the clinical and research work on pulmonary thromboembolism in China]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Nov;27(11):721-2. No abstract available. Chinese.

  PMID: 15634378 BACKGROUND

• 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.

  PMID: 15256085 BACKGROUND

• Wang F, Wang C, Wang T, Pang BS, Wu YB, Yang YH, Li C, Zhang HY, Weng XZ. [Experimental study of the thrombolytic effects in a canine model of pulmonary thromboembolism induced by autologous radioactive blood clots]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Feb;27(2):93-6. Chinese.

  PMID: 14990182 BACKGROUND

• 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.

  PMID: 14989818 BACKGROUND

• 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.

  PMID: 14720434 BACKGROUND

• Wang F, Wang C, Wang T, Pang BS, Wu YB, Yang YH, Li C, Zhang HY, Weng XZ. [A canine model of acute pulmonary thromboembolism induced by autologous radioactive blood clots]. Zhonghua Jie He He Hu Xi Za Zhi. 2003 Aug;26(8):470-3. Chinese.

  PMID: 14505523 BACKGROUND

• Wang C, Zhai Z, Yang Y, Yuan Y, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism Study Group. Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial. Respir Res. 2009 Dec 29;10(1):128. doi: 10.1186/1465-9921-10-128.

  PMID: 20040086 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Thromboembolism

Interventions

Urokinase-Type Plasminogen Activator; Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Officials

• Chen WANG, Prof

  Beijing Institute of Respiratory Medicine,Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

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 28, 2008
• First Posted: December 1, 2008
• Study Start: June 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

CN (31)