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Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368238
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : August 24, 2006
American Heart Association
Information provided by:
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Drug: Recombinant human erythropoietin alfa (drug) Drug: Aspirin (drug) Drug: Clopidogrel (drug) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
Study Start Date : October 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Bleeding time
  2. Platelet function assay closure time

Secondary Outcome Measures :
  1. Complete Blood Count
  2. PT
  3. PTT
  4. P-selectin
  5. von Willebrand factor

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00368238

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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
American Heart Association
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Principal Investigator: Stuart D Katz, MD Yale University
Layout table for additonal information Identifier: NCT00368238    
Other Study ID Numbers: 0506000139
AHA 0555844T
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: August 24, 2006
Last Verified: August 2006
Keywords provided by Yale University:
Platelet function tests
Additional relevant MeSH terms:
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Epoetin Alfa
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents