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Platelet Function With Various Storage Techniques

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ClinicalTrials.gov Identifier: NCT03338660
Recruitment Status : Withdrawn (Unable to begin study due to funding. PI has left organization.)
First Posted : November 9, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Northwell Health

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

Condition or disease Intervention/treatment Phase
Platelet Dysfunction Due to Drugs 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.

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Study Type : Interventional  (Clinical Trial)
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.
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
Estimated Study Start Date : July 15, 2018
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 15, 2020

Arm Intervention/treatment
Placebo Comparator: Control (Placebo)
Subjects will receive infusion of placebo (saline).
Biological: Placebo
Subjects will receive infusion placebo (saline).
Other Name: 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 Name: 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 Name: Novel Storage Methodology




Primary Outcome Measures :
  1. Change in platelet function [ Time Frame: 1 hour post-transfusion ]
    Frozen platelets will result in improvement in platelet function after transfusion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal subjects

Exclusion Criteria:

  • Pre existing antiplatelet drugs
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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT03338660    
Other Study ID Numbers: 16-XXXX-SIUHN
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No