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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00781378 |
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Date of registration:
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21/10/2008 |
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Primary sponsor: |
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Public title:
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Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
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Scientific title:
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Efficacy and Safety Evaluation of Low Dosage of Recombinant Tissue Plasminogen Activator (rt-PA) in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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118 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00781378 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Chen WANG, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Institute of Respiratory Medicine,Beijing Chao-Yang Hospital,Capital Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age between 18 and 75
- symptomatic PE confirmed by: a high probability ventilation-perfusion lung scanning
(V/Q scan) or the presence of intraluminal filling defect on spiral computed
tomographic pulmonary angiography (CTPA)
- PTE patients with haemodynamic instability, or cardiogenic shock
- anatomic obstruction more than 2 lobes on CTPA, or defect more than 7 segments on V/Q
scan combined with evidence of right ventricular dysfunction(RVD) and pulmonary
hypertension on echocardiography
- written informed consent
Exclusion Criteria:
- 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
- hemorrhagic retinopathy due to diabetes
- a known bleeding disorder
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Embolism
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Thromboembolism
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Intervention(s)
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Drug: rt-PA
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Primary Outcome(s)
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Perfusion defect score of lung V/Q scans
[Time Frame: within the 1st 14 days]
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Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment.
[Time Frame: within the 1st 14 days]
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The improvement of the right hart function on echocardiograms
[Time Frame: within the 1st 14 days]
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Secondary Outcome(s)
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Death
[Time Frame: within the 1st 14 days]
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Major or minor bleeding
[Time Frame: within 1st 14 days]
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PE recurrence
[Time Frame: within the 1st 14 days]
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Secondary ID(s)
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2001BA703B13
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2004BA703B07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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