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Completed

NCT Number: NCT00368238

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.

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant human erythropoietin alfa (drug)

Drug

Aspirin (drug)

Drug

Clopidogrel (drug)

Drug

Primary outcomes

  1. Bleeding time

  2. Platelet function assay closure time

Secondary outcomes

  1. Complete Blood Count

  2. PT

  3. PTT

  4. P-selectin

  5. von Willebrand factor

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Aug 24, 2006
Registry last updated
Aug 24, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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