Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Recombinant human erythropoietin alfa (drug); Drug: Aspirin (drug); Drug: Clopidogrel (drug)

Detailed Description

Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.

Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.

Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.

• Study Type: Interventional
• Enrollment: 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 21-40 years
• Able and willing to provide written informed consent
• Bleeding time <10 minutes

Exclusion Criteria:

• Any chronic medical disease
• Chronic or frequent over-the-counter or prescription medication use
• Hemoglobin >15 gm/dl for both genders or <13 gm/dl (men) or <12 gm/dl (women)
• Platelet count >400,000/µl or <150,000/µl
• Blood pressure > 140/90 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bleeding time
Platelet function assay closure time

Secondary Outcome Measures

Outcome Measure
Complete Blood Count
PT
PTT
P-selectin
von Willebrand factor

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Stuart D Katz, MD, Yale University

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion: July 1, 2006

Study Registration Dates

• First Submitted: August 23, 2006
• First Submitted That Met QC Criteria: August 23, 2006
• First Posted (Estimate): August 24, 2006

Study Record Updates

• Last Update Posted (Estimate): August 24, 2006
• Last Update Submitted That Met QC Criteria: August 23, 2006
• Last Verified: August 1, 2006

More Information

Terms related to this study

• Keywords: Aspirin; Erythropoietin; Clopidogrel; Platelet function tests
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Hematinics; Aspirin; Clopidogrel; Epoetin Alfa
• Other Study ID Numbers: 0506000139; AHA 0555844T