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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Treatments: Fibrinolytic Agents

Criteria

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.