Platelet Function With Various Storage Techniques

NCT ID: NCT03338660

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2020-07-15

Brief Summary

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

Detailed Description

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

Conditions

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Platelet Dysfunction Due to Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
the assesor of platelet function and the PI will be blinded to group.

Study Groups

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Control (Placebo)

Subjects will receive infusion of placebo (saline).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Subjects will receive infusion placebo (saline).

Platelet storage routine

Subjects will receive infusion of platelets stored by routine method.

Group Type ACTIVE_COMPARATOR

Infusion of Platelets

Intervention Type BIOLOGICAL

Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.

Platelet storage experimental

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

Group Type EXPERIMENTAL

Infusion of Platelets

Intervention Type BIOLOGICAL

Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).

Interventions

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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).

Intervention Type 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.

Intervention Type BIOLOGICAL

Placebo

Subjects will receive infusion placebo (saline).

Intervention Type BIOLOGICAL

Other Intervention Names

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Novel Storage Methodology Routine Storage Method Placebo (Saline)

Eligibility Criteria

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Inclusion Criteria

* Normal subjects

Exclusion Criteria

* Pre existing antiplatelet drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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16-XXXX-SIUHN

Identifier Type: -

Identifier Source: org_study_id

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