Tranexamic acid efficacy reducing surgery bleding in patients undergoing surgery for complete prostatectomy. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000588-41-IT

Enrollment

200

Registered

2008-02-20

Start date

2008-02-26

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients undergoing prostatic radical surgery for prostatic cancer MedDRA version: 9.1 Level: LLT Classification code 10038961 Term: Retro-pubic prostatectomy

Interventions

Trade Name: UGUROL Pharmaceutical Form: Solution for injection INN or Proposed INN: Tranexamic acid Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026