Infusion of a single dose of erythropoietin to Prevent Injury in an Ischemia Reperfusion forearm model - A randomised cross-over study to evaluate if infusion of a single dose of EPO protects against ischemia-reperfusion injury in man. - IPIIR

Phase 1

• Conditions: Myocardial ischemia-reperfusion injury.; MedDRA version: 9.1Level: LLTClassification code 10059512Term: Apoptosis; MedDRA version: 9.1Level: LLTClassification code 10028601Term: Myocardial ischemia; MedDRA version: 9.1Level: LLTClassification code 10051624Term: Myocardial reperfusion injury

• Registration Number: EUCTR2007-001089-33-NL
• Lead Sponsor: niversity Medical Center Groningen, dept. of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-29
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• Healthy volunteers between 18 and 40 years of age.
• Male.
• Volunteers are not allowed smoking 24 hours before the start of the experiment.

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Female.
• Hypertension (SBP >140 mmHg, DBP >90 mmHg).
• Diabetes Mellitus (DM) (fasting glc >6.9 mmol/l, glc >11.0 mmol/l).
• Hypercholesterolemia.
• Renal dysfunction (eGFR < 60 ml/min, calculated using MDRD formula).
• Any known hypersensitivity/allergic reaction to one of the constituents of Epoetin Alfa.
• A history of use of any form of EPO.
• Any current medication use.
• Cardiovascular disease in medical history.
• Smoking less than 24 hours prior to Epoetin alpha infusion.
• Participation in research in the last 5 years in which any form of radioactivity was used.
• No participation in any research trial in the last 30 days or 5 times the half-life of the used substance.

Study & Design

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