Clinical trial to determine the effectiveness of a new test of liver function (HEPATOTEST)

• Conditions: Hepatic Function.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-000537-24-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-22
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Group volunteers: volunteer subjects without severe liver pathology associated.
Group patients: Patients who are to undergo abdominal surgery (liver resection preferably in the context of the underlying pathology, eg liver metastases, hepatic adenoma, cholangiocarcinoma, etc ...).
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Group volunteers: under 18 years, pregnant and lactating women, allergy to any of the active substances or excipients, allergy to acetylsalicylic acid, liver pathology associated (cirrhosis, hepatitis, liver tumor pathology), moderate consumption of alcohol, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min).
Group patients: below 18, allergy to any of the active ingredients or allergy to acetylsalicylic acid, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min), the appearance of other pathological conditions over study that contraindicate surgery. Pregnant women and lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified