Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD).

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

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Nadroparin; Plasminogen; Tinzaparin; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. 18 y≤Age≤75y

2. Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram

3. Hemodynamic stability, diastolic pressure>90mmHg.

4. RV dysfunction confirmed by echocardiography (≥1 criterion), except left-side heart disease, congenital heart disease and mitral valve disease.

• Increase of the right ventricle showed presented with RV end-diastolic anteroposterior diameter >25 mm, Right/left ventricular end-diastolic diameter >1 (apical or subcostal 4-chamber view) or Right/left ventricular end-diastolic anteroposterior diameter >0.5

• Hypokinesis of RV-free wall (range of motion less than 5 mm)

• Tricuspid regurgitation pressure >30mmHg

Exclusion Criteria:

1. RV anterior wall thickness > 5mm confirmed by echocardiography

2. Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months

3. Major surgery, organ biopsy or non-compressible punctures within 2 weeks

4. Ischemic stroke occurred within 2 months

5. Gastrointestinal bleeding within 10 days

6. Severe trauma occurred within15 days

7. Neurosurgery or eye surgery within 1 months

8. Severe hypertension difficult to control (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)

9. Cardiopulmonary resuscitation

10. Platelet count less than 100×109 / L

11. Pregnancy, or within 2 week post partum

12. Infective endocarditis; left atrial thrombus; aneurysm

13. Serious liver and kidney dysfunction

14. Diabetic hemorrhagic retinopathy

15. Suffering with bleeding disorders

16. Chronic thromboembolic pulmonary hypertension

17. Moderate to severe chronic obstructive pulmonary disease (COPD).