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Prevención del sangrado postoperatorio: Ensayo clínico unicéntrico, aleatorizado, paralelo y controlado que evalúa la eficacia de la cola de fibrina y el ácido tranexámico en pacientes intervenidos de artroplastia total de rodilla.

Conditions
Pacientes que precisan de una artroplastia de rodilla.Patients with are needed of an arthroplasty of the knee.
Registration Number
EUCTR2009-017804-95-ES
Lead Sponsor
Fundació Institut de Recerca de l?Hospital de la Santa Creu i Sant Pau
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients older than 18 years
Intervention of primary total knee arthroplasty
Patient consent to participate in the study
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

Hypersensibility to the study drugs or the bovine proteins (aprotinin)
History of thromboembolic disease:
?Cerebrovascular accident
?Ischaemic cardiopathy
?Deep thrombosis venous and/or superficial
?Lung thromboembolism
?Periferical arterial vasculopathy
Patients with thromboembolic arrhythmias (AcxFA)
Patients with cardiovascular prosthesis
Coagulations prothrombotic disease
Treatment with with anticonceptives

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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