In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

NCT03097289 | Completed Results FDA Device

• 1 other identifier: CTS-5066
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the quality of platelets collected on the Trima Accel system after storage for 5 days in a Platelet Additive Solution (PAS), called InterSol.

Conditions

Healthy Volunteers

Keywords

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Recovered Percentage of the Extrapolated Platelet Count at Time 0

  The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is \>66% of control with a 1-sided 97.5% confidence limit.

  11 days (+/- 1 day)

• Number of Days of Platelet Survival

  Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is \>58% of control with a 1-sided 97.5% confidence limit

  11 days (+/- 1 day)

Study Arms (1)

Platelets stored in InterSol

EXPERIMENTAL

Platelets collected on the Trima Accel system and stored in 65% InterSol/35% plasma

Device: Trima Accel system

Interventions

Trima Accel system DEVICE

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 5 day storage. The entire procedure is painless and should take 90 to 120 minutes.

Platelets stored in InterSol

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Normal health status as per AABB criteria for a healthy donor
• Able to commit to the study schedule
• Participants of child-bearing potential (either male or female) must agree to use an effective method of contraception during the course of the study
• Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets
• Has given written informed consent

You may not qualify if:

• Previously received radiation therapy
• Has been diagnosed with a platelet disorder (ie, platelet dysfunction)
• Already participated in 4 research studies involving radioisotopes within the contemporaneous calendar-year
• Pregnant or nursing females
• Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation
• History of known hypersensitivity to indium or chromium
• Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (eg, ibuprofen or other NSAIDs)

Sponsors & Collaborators

• Terumo BCT: lead

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

BloodCenter of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Results Point of Contact

• Title: Ned Cosgriff, MD
• Organization: Terumo BCT, Inc.

ned.cosgriff@TerumoBCT.com

+1 303-239-2316

Study Officials

• Jose Cancelas, MD, PhD

  Hoxworth Blood Center

  PRINCIPAL INVESTIGATOR

• Mehraboon S Irani, MD

  Versiti Blood Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Apheresis platelets will be collected on the Trima Accel system and stored in 65% InterSol/35% plasma for all subjects

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 31, 2017
• Study Start: July 26, 2017
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: December 19, 2018
• Results First Posted: November 27, 2018

Record last verified: 2018-11

Locations

US (2)