Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00368238
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Drug: Recombinant human erythropoietin alfa (drug)
Drug: Aspirin (drug)
Drug: Clopidogrel (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Bleeding time
  • Platelet function assay closure time

Secondary Outcome Measures:
  • Complete Blood Count
  • PT
  • PTT
  • P-selectin
  • von Willebrand factor

Estimated Enrollment: 96
Study Start Date: October 2005
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368238

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
American Heart Association
Investigators
Principal Investigator: Stuart D Katz, MD Yale University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00368238     History of Changes
Other Study ID Numbers: 0506000139, AHA 0555844T
Study First Received: August 23, 2006
Last Updated: August 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Platelet function tests
Erythropoietin
Aspirin
Clopidogrel

Additional relevant MeSH terms:
Clopidogrel
Epoetin alfa
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematinics

ClinicalTrials.gov processed this record on September 16, 2014