Trima Accel® System Post Count Algorithm Study
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/18/2016 |
| Start Date: | January 2016 |
| End Date: | May 2016 |
A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
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.
platelet collections, while maintaining donor postplatelet count of >100,000/µL.
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.
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.
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.
We found this trial at
2
sites
San Diego, California 92103
Principal Investigator: Diane Eklund, MD
Phone: 619-400-8150
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