Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368238
• Other study ID #: 0506000139
• Secondary ID: AHA 0555844T
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2006
• Last updated: August 23, 2006
• Start date: October 2005
• Est. completion date: July 2006

Study information

• Verified date: August 2006
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Recombinant human erythropoietin alfa (drug)

• Aspirin (drug)

• Clopidogrel (drug)

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding time
Primary	Platelet function assay closure time
Secondary	Complete Blood Count
Secondary	PT
Secondary	PTT
Secondary	P-selectin
Secondary	von Willebrand factor