At a glance

ClinicalIndex Comparison Record

N/ACompleted· 87 enrolled

Drug / intervention

Platelets stored in InterSol +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02298842

NCT02298842N/ACompleted

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In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

Terumo BCT·interventional·Posted Nov 24, 2014·Updated Jul 21, 2017

In Brief

A clinical study evaluating Platelets stored in InterSol and Platelets stored in Plasma for Healthy Volunteers. Completed, enrolled 87 participants across 2 sites.

Detailed Summary

This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy Volunteers

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

201520162017201820192020202120222023202420252026

First PostedNov 2014

Enrollment StartNov 2015

Primary CompletionMay 2016

TodayJul 2026

First PostedNov 24, 2014

Enrollment StartNov 5, 2015

Primary CompletionMay 12, 2016

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 11.6 years ago

Interventions

Platelets stored in InterSoldevice

A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.

Platelets stored in Plasmadevice

A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.