Status:
COMPLETED
Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Pulmonary Embolism
Thromboembolism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Recombinant tissue plasminogen activator (rt-PA) is currently the most commonly used thrombolytic drug in patients with pulmonary thromboembolism (PTE). Optimal dosing with maximal benefits and minima...
Detailed Description
Pulmonary thromboembolism (PTE) is a severe and common clinical problem with substantial morbidity and mortality both in US and in Europe. Used to be considered as a rare disease in China, PTE has bee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00781378
Start Date
June 1 2002
End Date
February 1 2006
Last Update
October 29 2008
Active Locations (23)
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1
Beijing Chaoyang Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100020
2
Beijing University People's Hospital
Beijing, Beijing Municipality, China
3
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
4
The Omni-hospital of Air-force
Beijing, Beijing Municipality, China