Status:
COMPLETED
Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC)
Lead Sponsor:
Beijing Chao Yang Hospital
Collaborating Sponsors:
Qingdao University
Tianjin Medical University General Hospital
Conditions:
Pulmonary Embolism
Pulmonary Thromboembolism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering. Its characteristics of high output and low production cost make it affordable in treating acute myo...
Detailed Description
Pulmonary embolism (PE) is a common cardiovascular illness. Massive PE is characterized with cardiogenic shock and/or persistent arterial hypotension. Submassive PE patients are defined with right ven...
Eligibility Criteria
Inclusion
- Symptomatic PTE confirmed either by CTPA or by a high probability ventilation-perfusion lung scanning (V/Q scan).
- Presented with hemodynamic instability (systolic blood pressure \<90 mmHg or a fall in systolic blood pressure of more than 40 mmHg for at least 15 min, or cardiogenic shock) or associated with RVD identified by echocardiography or CT.
- Symptoms deterioration less than 14 days before diagnosis.
Exclusion
- Active bleeding or spontaneous intracranial hemorrhage in the preceding 6 months
- Major surgery, organ biopsy or recent puncture of a non-compressible vessel in the preceding 2 weeks
- Cerebral arterial thrombosis in the preceding 2 months
- Gastro-intestinal bleeding in the preceding 10 days
- Major trauma within the past 15 days
- Neurosurgery or ophthalmologic operation in the preceding 1 month
- 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 in the preceding 2 weeks
- Infectious pericarditis or endocarditis
- Severe hepatic and kidney dysfunction
- Hemorrhagic retinopathy due to diabetes
- A known bleeding disorder.
- Chronic thromboembolic pulmonary hypertension (CTEPH) without new pulmonary thromboembolism (PTE)
- Received streptokinase in the preceding 6 months
- Infected by streptococcus in the preceding 1 month.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00968929
Start Date
June 1 2006
End Date
May 1 2009
Last Update
September 1 2009
Active Locations (8)
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1
Beijing Institute of Respiratory Medicine, Beijing Chao-Yang hospital
Beijing, Beijing Municipality, China, 100020
2
Guangdong Institute of Respiratory Disease, Guangzhou Medical University,
Guangzhou, Guangdong, China, 510120
3
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
4
The General Hospital of Shenyang Military Command
Shenyang, Liaoning, China, 110016