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Pulmonary EmbolismPhase 4UKPTECNCT00799968

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

A Phase 4 study testing Urokinase in people with Pulmonary Embolism and Thromboembolism, run by Beijing Chao Yang Hospital at 31 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Embolism, Thromboembolism
What is being tested?
Urokinase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
31 sitesChina
Study dates
Jun 2002to Feb 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 17Show fewer
  • 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;
  • hemorrhagic retinopathy due to diabetes;
  • a known bleeding disorder.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Beijing Chaoyang Hospital, Capital University of Medical Sciences

    Beijing, Beijing Municipality, 100020

  • Beijing General Hospital of the Air-force PLA

    Beijing, Beijing Municipality, 100036

  • Beijing Fu Xing Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100037

  • Beijing Naval General Hospital

    Beijing, Beijing Municipality, 100037

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730

  • The Fifth People's Hospital of Datong in ShanxiWANG;

    Datong, Shanxi

  • The First Affiliated Hospital Sun Yat-Sen University

    Guangzhou, Guandong, 510120

  • Guangzhou Institute of Respiratory Disease，Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Sir Run Run Shaw Hospital, Affiliated with Zhejiang University

    Hangzhou, Zhejiang, 310016

  • Qilu Hospital Affiliated to Shandong University

    Jinan, Shandong, 250012

  • The First Affiliated Hospital of Jining Medical College

    Jinan, Shangdong

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530027

  • The Affiliated Hospital of Medical College Qingdao

    Qingdao, Shandong, 266003

  • The First Affiliated Hospital of Qingdao University CHENG Zhao-zhong

    Qingdao, Shangdong

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • The General Hospital of Shenyang Military Command

    Shenyang, Liaoning, 110016

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • The Second Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Tangshan Worker's Hospital, Hebei Medical University

    Tangshan, Hebei, 063000

  • The Affiliated Hospital of Hubei Coal University

    Tangshan, Hebei, 063000

  • Tianjin Thoracic Hospital

    Tianjin, Tianjin Municipality, 300051

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Xinjiang People's Hospital

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Shangdong Yantaishan Hospital

    Yantai, Shandong

Other trials in China

About this study

Official title: Efficacy and Safety Evaluation of 12-h and 2-h Urokinase Regimes in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China

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.

Read the detailed description

Pulmonary thromboembolism (PTE), a frequent life-threatening complication of deep vein thrombosis (DVT), is often underestimated and under diagnosed . Effective early treatment will decrease the mortality, reverse right heart dysfunction and reduce risk of chronic thromboembolic pulmonary hypertension (CTEPH) or post-thrombotic syndrome (PTS). Thrombolysis has proved to be the most rapid and effective therapy to reduce the obstruction of pulmonary circulation and normalize hemodynamic parameters. The ultimate goals of thombolytic therapy for this disease are to minimize early morbidity and mortality and to prevent recurrence without provoking excessive bleeding.

Currently, the choice of thrombolytic agents and regimens (either UK or rt-PA) is mostly based on personal or regional preferences. A loading dose of UK 4400 IU/kg followed by 2200 IU/kg/hour for 12 hours (UK-12h), or rt-PA 100 mg infusion over 2 hours are recommended for acute PTE treatment. However, increasing evidence suggest that UK infusion can be more concentrated and time can be further reduced. 100 mg/2 h of rt-PA and a novel dosing regimen of UK(3 million U/2 h) had been compared. The results indicated that a 2-h regimen of rt-PA and 2h UK exhibited similar efficacy and safety for treatment of acute PTE. UK-2h(20 000U/Kg) regimen combined with low molecular weight heparin (LMWH) had been used in Chinese population.No severe bleeding and allergic reaction occurred in the thrombolytic group. This dosage is much lower than that used by Goldhaber et al, but the efficacy was prominent. Until now,no study have been reported to compared UK-2h(20 000U/Kg) regimen with other UK regimens(such as UK-12h).

A relative lower dosage of UK 2-h regimen with body weight adjusted may be an alternative choice for treating PTE patients in Chinese population.Considering lower cost and convenience of this regimen, the efficacy and safety between UK-2h regimen(20 000U/Kg) and ACCP-approved UK-12h regimen for treating acute PTE will be compared.The study is conducted on patients with massive PTE with shock or hypotension and/or if without shock or hypotension but with right ventricular dysfunction. The clinical efficacy, emboli dissolving efficacy and safety will be evaluated.

Being tested
Urokinase
Keywords
Thrombolytic therapy, Urokinase, Efficacy, Safety
Medical subject headings
Pulmonary Embolism, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UrokinaseDrug

    Also called Urokinase,thrombolytic agent

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

  • UrokinaseDrug

    Also called Urokinase,thrombolytic agent

    UK,20 000U/kg continuously intravenous infusion for 2 hours

Study groups in NCT00799968
Study groupRoleWhat they receive
Group 1Active comparatorUK-12h group
Receives: Drug: Urokinase
Group 2ExperimentalUK-2h group
Receives: Drug: Urokinase

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 14d

Secondary outcomes (1)

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

    Measured: 14d

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2008 (estimated)
  2. Study startJun 2002
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799968
Sponsor's protocol ID
2004BA703B07-UK
Acronym
UKPTEC
Status last verified
Nov 2008
First submitted
28 Nov 2008
Last updated
1 Dec 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18261355

  • 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.

    PubMed 17716753

  • 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.

    PubMed 17640719

  • 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.

    PubMed 17705052

  • 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.

    PubMed 17254482

  • 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.

    PubMed 16796899

  • 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.

    PubMed 16207426

  • 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.

    PubMed 15854334

  • 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.

    PubMed 15634378

  • 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.

    PubMed 15256085

  • 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.

    PubMed 14990182

  • 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.

    PubMed 14989818

  • 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.

    PubMed 14720434

  • 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.

    PubMed 14505523

  • 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.

    PubMed 20040086

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Urokinase in people with Pulmonary Embolism and Thromboembolism, run by Beijing Chao Yang Hospital at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (time frame: 14d). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00799968, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2008.

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