abdominal aortic aneurysm MedDRA version: 17.0 Level: LLT Classification code 10000054 Term: Abdominal aortic aneurysm System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Ugurol
Product Name: Ugurol
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
IRCCS Ospedale San Raffaele
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age> 50 years Ability to provide written informed consent Patient undergoing surgery of abdominal aortic aneurysmectomy 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Patients who participated in a drug trial in the previous three months Intervention under the emergency / urgency Uncooperative patient and / or mental changes Reported allergy or intolerance to study drug History of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluation of the blood (ml) lost during surgery;Secondary Objective: packed red blood cells transfused during hospitalization, mortality at 28 days and one year;Primary end point(s): evaluation of the blood (ml) lost during surgery;Timepoint(s) of evaluation of this end point: end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): packed red blood cells transfused during hospitalization, mortality at 28 days and one year;Timepoint(s) of evaluation of this end point: discharge, 28 days and one year | — |
Countries
Italy
Contacts
Public ContactDip di Anestesia e Rianimazione
IRCCS Ospedale San Raffaele
Outcome results
None listed