Platelet Function With Various Storage Techniques

The Impact of Various Storage Techniques on Platelet Function

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

Study Overview

• Status: Withdrawn
• Conditions: Platelet Dysfunction Due to Drugs
• Intervention / Treatment: Biological: Placebo; Biological: Infusion of Platelets; Biological: Infusion of Platelets

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: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Normal subjects

Exclusion Criteria:

• Pre existing antiplatelet drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).; Other Names: 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 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in platelet function	Frozen platelets will result in improvement in platelet function after transfusion.	1 hour post-transfusion

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2018
• Primary Completion (Anticipated): July 15, 2019
• Study Completion (Anticipated): July 15, 2020

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 16-XXXX-SIUHN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No