Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China

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

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 minimal risks is of great importance. Considering the lower body weight in general Chinese population, we compared the efficacy and safety of lower dose rt-PA 50mg/2h regimen with the FDA-approved rt-PA 100mg/2h regimen in selected PTE patients.

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

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

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