Trima Accel® System Post Count Algorithm Study

Healthy Volunteers Clinical Trial

Official title:

A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684630
• Other study ID #: CTS-5054
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: September 7, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.

Description:

This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

1. a single platelet product is collected

2. a double platelet product is collected, with or without other components.

Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.

• Appears to have adequate venous access to obtain a postprocedure platelet count.

• Has given written informed consent.

Exclusion Criteria:

• Has undergone a splenectomy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Trima Accel System
Platelet Apheresis Procedure

Locations

Country	Name	City	State
United States	Bonfils Blood Center	Denver	Colorado
United States	San Diego Blood Bank	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donor Post Procedure Platelet Count Following Donation of Single Platelet Product	The primary endpoint for this study is the postprocedure donor platelet count for donors who have completed a single platelet collection procedure. A procedure is a success if the donor's postprocedure platelet count is =100,000/µL.	The blood draw to determine post procedure platelet count will occur approximately 15 minutes after the end of apheresis	Yes
Primary	Donor Post Procedure Platelet Count Following Donation of Double Platelet Product	The primary endpoint for this study is the postprocedure donor platelet count for donors who have completed a double platelet collection procedure. A procedure is a success if the donor's postprocedure platelet count is =100,000/µL.	The blood draw to determine post procedure platelet count will occur approximately 15 minutes after the end of apheresis	Yes
Secondary	Platelet Product Platelet Count (x10^3/uL)	Secondary endpoint will consist of the product platelet counts.	A sample to determine platelet count will be taken from the platelet product bag up to 5 days after the end of the apheresis procedure.	No
Secondary	Platelet Product Volume (mL)	Secondary endpoint will consist of the product platelet volumes.	Platelet product volume will be determined up to 5 days after the end of the apheresis procedure.	No
Secondary	Platelet Product Yield (x10^11)	Secondary endpoint will consist of the product yield.	A sample to determine platelet yield will be taken from the platelet product bag up to 5 days after the end of the apheresis procedure.	No
Secondary	Residual White Blood Cell (rWBC) Count (x10^3/uL) in Platelet Product	Secondary endpoint will consist of the residual white blood cell counts.	A sample to determine rWBC count will be taken from the platelet product bag up to 5 days after the end of the apheresis procedure.	No
Secondary	pH of Platelet Product	Secondary endpoint will consist of the platelet product pH.	A sample to determine pH will be taken from the platelet product bag up to 5 days after the end of the apheresis procedure.	No