Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 myocardial infarction (AMI) in developing countries. It is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000 IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Collaborators: General Hospital of Shenyang Military Region; Guangdong Institute of Respiratory Disease; Ningxia Medical University; Qingdao University; Shenzhen People's Hospital; The First Affiliated Hospital of Shanxi Medical University; Tianjin Medical University General Hospital
• Treatments: Streptokinase

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.