Status:
COMPLETED
12-h and 2-h Urokinase Regimes of Pulmonary Thromboembolism in China
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Pulmonary Embolism
Thromboembolism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ti...
Detailed Description
Pulmonary thromboembolism (PTE), a frequent life-threatening complication of deep vein thrombosis (DVT), is often underestimated and under diagnosed . Effective early treatment will decrease the morta...
Eligibility Criteria
Inclusion
- 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
- Received parenteral heparin for more than 72 hours
- Known allergic to urokinase
- Thrombolytic contraindications such as:
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00799968
Start Date
June 1 2002
End Date
February 1 2006
Last Update
December 1 2008
Active Locations (31)
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1
Beijing Chaoyang Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100020
2
Beijing General Hospital of the Air-force PLA
Beijing, Beijing Municipality, China, 100036
3
Beijing Fu Xing Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100037
4
Beijing Naval General Hospital
Beijing, Beijing Municipality, China, 100037