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Platelet Function With Various Storage Techniques

Sponsor
Northwell Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03338660
Collaborator
(none)
0
Enrollment
3
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Infusion of Platelets
  • Biological: Infusion of Platelets
  • Biological: Placebo
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
the assesor of platelet function and the PI will be blinded to group.
Primary Purpose:
Treatment
Official Title:
The Impact of Various Storage Techniques on Platelet Function
Anticipated Study Start Date :
Jul 15, 2018
Anticipated Primary Completion Date :
Jul 15, 2019
Anticipated Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control (Placebo)

Subjects will receive infusion of placebo (saline).

Biological: Placebo
Subjects will receive infusion placebo (saline).
Other Names:
  • Placebo (Saline)

    		•
    Active Comparator: Platelet storage routine

    Subjects will receive infusion of platelets stored by routine method.

    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.
    Other Names:
  • Routine Storage Method

    		•
    Experimental: Platelet storage experimental

    Subjects will receive infusion of platelets stored by a novel methodology.

    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).
    Other Names:
  • Novel Storage Methodology

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in platelet function [1 hour post-transfusion]

      Frozen platelets will result in improvement in platelet function after transfusion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal subjects
    Exclusion Criteria:
    • Pre existing antiplatelet drugs

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Northwell Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northwell Health
    ClinicalTrials.gov Identifier:
    NCT03338660
    Other Study ID Numbers:
    • 16-XXXX-SIUHN
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 29, 2019