NCT02298842

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

November 5, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 14, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

November 14, 2014

Results QC Date

April 5, 2017

Last Update Submit

July 18, 2017

Conditions

Healthy Volunteers

Keywords

Healthy Adults

Outcome Measures

Primary Outcomes (2)

  • pH of Platelets at Day 5

    The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.

    Day 5

  • pH of Platelets at Day 7

    The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.

    Day 7

Secondary Outcomes (8)

  • Percent of Platelets Activated as Measured by P-selectin

    Day 5

  • Percent of Extent of Shape Change

    Day 5

  • Percent of Platelets Exhibiting Hypotonic Shock Response

    Day 5

  • Platelet Morphology

    Day 5

  • Percent of Platelets Activated as Measured by P-selectin

    Day 7

  • +3 more secondary outcomes

Study Arms (2)

Platelets Stored in Plasma

ACTIVE COMPARATOR

Platelets stored in Plasma

Device: Platelets stored in Plasma

Test Platelets Stored in InterSol

EXPERIMENTAL

Platelets stored in InterSol

Device: Platelets stored in InterSol

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.

Test Platelets Stored in InterSol
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.

Platelets Stored in Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years of age or older

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (6)

  • Dumont LJ, Cancelas JA, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. Transfusion. 2013 May;53(5):972-80. doi: 10.1111/j.1537-2995.2012.03841.x. Epub 2012 Aug 6.

    PMID: 22882530BACKGROUND

  • Ringwald J, Walz S, Zimmermann R, Zingsem J, Strasser E, Weisbach V, Eckstein R. Hyperconcentrated platelets stored in additive solution: aspects on productivity and in vitro quality. Vox Sang. 2005 Jul;89(1):11-8. doi: 10.1111/j.1423-0410.2005.00645.x.

    PMID: 15938735BACKGROUND

  • Cohn CS, Stubbs J, Schwartz J, Francis R, Goss C, Cushing M, Shaz B, Mair D, Brantigan B, Heaton WA. A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion. 2014 Aug;54(8):1927-34. doi: 10.1111/trf.12597. Epub 2014 Apr 16.

    PMID: 24735171BACKGROUND

  • Diedrich B, Sandgren P, Jansson B, Gulliksson H, Svensson L, Shanwell A. In vitro and in vivo effects of potassium and magnesium on storage up to 7 days of apheresis platelet concentrates in platelet additive solution. Vox Sang. 2008 Feb;94(2):96-102. doi: 10.1111/j.1423-0410.2007.01002.x. Epub 2007 Nov 22.

    PMID: 18034788BACKGROUND

  • Gulliksson H, AuBuchon JP, Vesterinen M, Sandgren P, Larsson S, Pickard CA, Herschel I, Roger J, Tracy JE, Langweiler M; Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang. 2002 Apr;82(3):131-6. doi: 10.1046/j.1423-0410.2002.drfgv158.x.

    PMID: 11952987BACKGROUND

  • Dumont LJ, VandenBroeke T, Ault KA. Platelet surface P-selectin measurements in platelet preparations: an international collaborative study. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfus Med Rev. 1999 Jan;13(1):31-42. doi: 10.1016/s0887-7963(99)80086-8. No abstract available.

    PMID: 9924762BACKGROUND

Results Point of Contact

Title
Heather Pidcoke, MD, PhD
Organization
Terumo BCT
Heather.Pidcoke@terumobct.com
(303) 231-4805

Study Officials

  • Jose Cancelas-Perez, MD, PhD

    Hoxworth Blood Center

    PRINCIPAL INVESTIGATOR

  • Mehraboon S Irani, MD

    Clood Center of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 24, 2014

Study Start

November 5, 2015

Primary Completion

May 12, 2016

Study Completion

May 12, 2016

Last Updated

July 21, 2017

Results First Posted

July 14, 2017

Record last verified: 2017-07

Locations

US(2)