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A ONE YEAR STUDY ON THE USE OF TRANEXAMIC ACID IN BENIGN PROSTATIC HYPERPLASIA SURGERY

Conditions
BENIGN PROSTATIC HYPERTROPHY
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Registration Number
EUCTR2013-004320-11-ES
Lead Sponsor
CARLOS SANTOS VILLAR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

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

MALE OVER 50 YEARS PERFORMING TRANSURETHRAL RESECTION OF PROSTATE OR RETROPUBIC ADENOMECTOMY BECAUSE OF BENIGN PROSTATIC HYPERTROPHY
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

PATIENT REFUSAL TO THEIR PARTICIPATION IN THE STUDY. EMEPERGENCY SURGERY. PAST OF ARTERIAL OR VENOUS THROMBOSIS. THROMBOFILIA. KIDNEY INJURY. PAST OF CONVULSION

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: COMPARING PERIOPERATIVE ANEMIA;Secondary Objective: NEED FOR TRANSFUSION<br>COMPLICATIONS<br>LENGTH OF HOSPITAL STAY;Primary end point(s): HEMOGLOBIN, HEMATOCRIT, PLATELETS, COAGULATIONS TIMES, FIBRINOGEN;Timepoint(s) of evaluation of this end point: FIRST DAY AND FIFTH DAY
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): NEED FOR TRANSFUSION<br>COMPLICATIONS<br>LENGTH OF HOSPITAL STAY;Timepoint(s) of evaluation of this end point: FIRST DAY AND FIFTH DAY
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