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A multi-center, randomized, double blind, placebo controlled study to investigate the efficacy and safety of Aprotinin on transfusion requirements in patients with bladder cancer undergoing radical or...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-004055-35

A multi-center, randomized, double blind, placebo controlled study to investigate the efficacy and safety of Aprotinin on transfusion requirements in patients with bladder cancer undergoing radical or total cystectomy

Femme et Homme

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Extrait

Main objective: The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for subsequent blood transfusion in subjects with bladder cancer undergoing to radical or total cystectomy. The undermentioned procedures are allowed and belong to radical and total cystectomy: 1. total cystectomy 2. radical cystectomy procedures = cystectomy plus removal of adjacent tissues: cystoprostatectomy, removal of bladder and anterior vaginal wall, cystectomy plus ovariectomy and or hysterectomy 3. urinary tract reconstructive procedures: incontinent cutaneous diversion (eg ileal conduit, etc), continent cutaneous diversion (eg Indiana pouch, etc), orthotopic diversion (eg neobladder)

Critère d'inclusion

  • Radical or total cystectomy on patients with bladder cancer

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