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

November 28, 2008 updated by: Beijing Chao Yang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

129

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, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • 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, 100730
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital, Capital University of Medical Sciences
      • Beijing, Beijing, China, 100037
        • Beijing Fu Xing Hospital, Capital Medical University
    • Guandong
      • Guangzhou, Guandong, China, 510120
        • The First Affiliated Hospital Sun Yat-Sen University
    • Guangdong
      • 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
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110016
        • The General Hospital of Shenyang Military Command
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital Affiliated to Shandong University
      • Qingdao, Shandong, China, 266003
        • The Affiliated Hospital of Medical College Qingdao
      • Yantai, Shandong, China
        • Shangdong Yantaishan Hospital
    • Shangdong
      • Jinan, Shangdong, China
        • The First Affiliated Hospital of Jining Medical College
      • Qingdao, Shangdong, China
        • The First Affiliated Hospital of Qingdao University CHENG Zhao-zhong
    • Shanxi
      • Datong, Shanxi, China
        • The Fifth People's Hospital of Datong in ShanxiWANG;
      • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Received parenteral heparin for more than 72 hours
  • Known allergic to urokinase

  • Thrombolytic contraindications such as:

    1. active bleeding or spontaneous intracranial hemorrhage;
    2. major surgery, organ biopsy or recent puncture of a non-compressible vessel less than 10 days;
    3. cerebral arterial thrombosis within 2 months;
    4. gastro-intestinal bleeding within 10 days;
    5. major trauma within the past 15 days;
    6. neurosurgery or ophthalmologic operation with 30 days;
    7. uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg);
    8. recent external cardiac resuscitation manoeuvres;
    9. platelet count < 100 000/mm3 at admission;
    10. pregnancy, puerperium or lactation with 2 weeks;
    11. infectious pericarditis or endocarditis;
    12. severe hepatic and kidney dysfunction;
    13. hemorrhagic retinopathy due to diabetes;
    14. a known bleeding disorder.

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
Active Comparator: Group 1
UK-12h group
Drug: Urokinase
UK,bolus 4 400 U/kg followed by intravenous 2 200 U/kg•h for 12 hours
Other Names:
  • Urokinase,thrombolytic agent
Drug: Urokinase
UK,20 000U/kg continuously intravenous infusion for 2 hours
Other Names:
  • Urokinase,thrombolytic agent
Experimental: Group 2
UK-2h group
Drug: Urokinase
UK,bolus 4 400 U/kg followed by intravenous 2 200 U/kg•h for 12 hours
Other Names:
  • Urokinase,thrombolytic agent
Drug: Urokinase
UK,20 000U/kg continuously intravenous infusion for 2 hours
Other Names:
  • Urokinase,thrombolytic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14d

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of major or minor bleeding, death rate, and PTE recurrence at 14d after treatment.
Time Frame: 14d
14d

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 28, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2008

Last Update Submitted That Met QC Criteria

November 28, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004BA703B07-UK

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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