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Platelet Function With Various Storage Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Unable to begin study due to funding.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

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE July 15, 2018
Estimated Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
Change in platelet function [ Time Frame: 1 hour post-transfusion ]
Frozen platelets will result in improvement in platelet function after transfusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Platelet Function With Various Storage Techniques
Official Title  ICMJE The Impact of Various Storage Techniques on Platelet Function
Brief Summary Platelet function will be tested in individuals on antiplatelet medications to determine the optimal storage methodology.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Platelet Dysfunction Due to Drugs
Intervention  ICMJE
  • 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
  • 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
  • Biological: Placebo
    Subjects will receive infusion placebo (saline).
    Other Name: Placebo (Saline)
Study Arms  ICMJE
  • Placebo Comparator: Control (Placebo)
    Subjects will receive infusion of placebo (saline).
    Intervention: Biological: Placebo
  • Active Comparator: Platelet storage routine
    Subjects will receive infusion of platelets stored by routine method.
    Intervention: Biological: Infusion of Platelets
  • Experimental: Platelet storage experimental
    Subjects will receive infusion of platelets stored by a novel methodology.
    Intervention: Biological: Infusion of Platelets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 24, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
10
Estimated Study Completion Date  ICMJE July 15, 2020
Estimated Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Normal subjects

Exclusion Criteria:

  • Pre existing antiplatelet drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03338660
Other Study ID Numbers  ICMJE 16-XXXX-SIUHN
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northwell Health
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP