Platelet Function With Various Storage Techniques

Overview

Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.

Full Title of Study: “The Impact of Various Storage Techniques on Platelet Function”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 15, 2019

Detailed Description

Subjects will undergo administration of antiplatelet drugs and then will receive platelets stored in a variety of methods. Platelet function will be measured serially.

Interventions

  • Biological: Infusion of Platelets
    • Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).
  • Biological: Infusion of Platelets
    • Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.
  • Biological: Placebo
    • Subjects will receive infusion placebo (saline).

Arms, Groups and Cohorts

  • Placebo Comparator: Control (Placebo)
    • Subjects will receive infusion of placebo (saline).
  • Active Comparator: Platelet storage routine
    • Subjects will receive infusion of platelets stored by routine method.
  • Experimental: Platelet storage experimental
    • Subjects will receive infusion of platelets stored by a novel methodology.

Clinical Trial Outcome Measures

Primary Measures

  • Change in platelet function
    • Time Frame: 1 hour post-transfusion
    • Frozen platelets will result in improvement in platelet function after transfusion.

Participating in This Clinical Trial

Inclusion Criteria

  • Normal subjects Exclusion Criteria:

  • Pre existing antiplatelet drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Northwell Health
  • Provider of Information About this Clinical Study
    • Sponsor

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