Platelet Function With Various Storage Techniques

NCT03338660 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 16-XXXX-SIUHN
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Platelet Dysfunction Due to Drugs

Outcome Measures

Primary Outcomes (1)

• Change in platelet function

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

  1 hour post-transfusion

Study Arms (3)

Control (Placebo)

PLACEBO COMPARATOR

Subjects will receive infusion of placebo (saline).

Biological: Placebo

Platelet storage routine

ACTIVE COMPARATOR

Subjects will receive infusion of platelets stored by routine method.

Biological: Infusion of Platelets

Platelet storage experimental

EXPERIMENTAL

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

Biological: Infusion of Platelets

Interventions

Infusion of Platelets 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).

Also known as: Novel Storage Methodology

Platelet storage experimental

Placebo BIOLOGICAL

Subjects will receive infusion placebo (saline).

Also known as: Placebo (Saline)

Control (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal subjects

You may not qualify if:

• Pre existing antiplatelet drugs

Sponsors & Collaborators

• Northwell Health: lead

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the assesor of platelet function and the PI will be blinded to group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: crossover study of various storage infusions techniques with each subject receiving various fluids aliquots.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: November 9, 2017
• Study Start: July 15, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2020
• Last Updated: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share