Tranexamic acid efficacy reducing surgery bleding in patients undergoing surgery for complete prostatectomy. - ND
Phase 1
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10038961Term: Retro-pubic prostatectomypatients undergoing prostatic radical surgery for prostatic cancer
- Registration Number
- EUCTR2008-000588-41-IT
- Lead Sponsor
- OSPEDALE S. RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
patients aged 18 years or more; -patients undergoing prostatic radical surgery for prostatic cancer
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
patients aged < 18 years old; -patients with medicl stents; patients with atrial fibrillation; -congenit or acquired trombofilia; - hypersensibility to tranexamic acid; -severe renal insufficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate the percent of patients undergoing blood transfusion during surgery;Secondary Objective: to evaluate bleeding during surgery;Primary end point(s): evaluate the percent of patients undergoing blood transfusion during surgery
- Secondary Outcome Measures
Name Time Method