Status:
COMPLETED
Nadroparin for the Initial Treatment of Pulmonary Thromboembolism
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Pulmonary Embolism
Thromboembolism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be s...
Detailed Description
Low-molecular-weight heparin (LWMH) appears to be at least as effective and safe as standard, unfractionated heparin (UFH)for the treatment of patients with deep vein thrombosis(DVT) and may also be s...
Eligibility Criteria
Inclusion
- 18 to 75 years of age
- Symptomatic non massive PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
- Haemodynamic stabile, anatomic obstruction no more than 2 lobes on CTPA, or defect no more than 7 segments on V/Q scan,and normal right ventricular function
- Symptoms within 15 days
- Written informed consent obtained before randomization.
Exclusion
- Unfractioned heparin anticoagulation for more than 36 hours prior enrollment,
- Massive PTE or sub-massive PTE requiring thrombolytic therapy or pulmonary embolectomy; Active bleeding or disorders contraindicating anticoagulant therapy
- Chronic thromboembolism pulmonary hypertension(CTEPH) without evidence of recent episode; Severe hepatic or renal failure
- Allergy to heparin, other components of Tinzaparin or acenocoumarol,
- Pregnant status;a life expectancy of less than 3 months;
- Previous thrombocytopenia induced by heparin
- Thrombocytopenia \< 100000/mm3,
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00796692
Start Date
June 1 2002
End Date
February 1 2006
Last Update
November 24 2008
Active Locations (39)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Beijing General Hospital of the Air-force PLA
Beijing, Beijing Municipality, China, 100036
3
Beijing Naval General Hospital
Beijing, Beijing Municipality, China, 100037
4
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044