Patients with clinical suspicion of Pulmonar Thromboembolism confirmed according to the PIOPED criteria. MedDRA version: 4.0 Level: PT Classification code 10037377
Conditions
Interventions
Trade Name: Innohep 20000 IU/ml
Pharmaceutical Form: Injection*
Trade Name: Sintrom
Pharmaceutical Form: Tablet
Sponsors
FARMACUSI, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinical suspicion of Pulmonar Thromboembolism, which future confirmed diagnostic with perfusion lung scan (high probability according to PIOPED criteria), spiral computed tomography, or pulmonary angiography. Patients should have 18 years or more, give consent and accept to be treated with an injected product at home, being capable to self administrated or with a closer person. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with massive Pulmonar Thromboembolism , with haemodinamic instability, where the fibrinolitic treatment would be indicated. Indication of permanent anticoagulant treatment (eg. mechanical valve, auricular fibrilation, known genetical defect that would suppose an hipercoagulation state). Pregnancy women. Life expectancy less than 6 months. Risk of bleeding, contraindication of acenocumarol, tinzaparin or other heparins. platelet count <100000/mm3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determinate the efficacy and feasibility of the ambulatory treatment with tinzaparin in the secondary profilaxis of pulmonar thromboembolism compared with acenocumarole.;Secondary Objective: Compare the safety of these 2 drugs Compare the hospital stay with both treatments Compare the direct and indirect costs in every group;Primary end point(s): The efficacy of both treatments will be evaluated with the number of thromboembolic recurrences for each drug. | — |
Countries
Spain
Outcome results
None listed