Related Experiment Video
Updated: Jul 12, 2026
Routine Screening Method for Microparticles in Platelet Transfusions
Published on: January 31, 2018
Frequent plateletpheresis does not clinically significantly decrease platelet counts in donors
Louis Katz1, Kim Palmer, Emily McDonnell
1Mississippi Valley Regional Blood Center, Davenport, Iowa, USA. lkatz@mvrbc.com
Insights
Proposed FDA restrictions on platelet (PLT) collections are unnecessary. Frequent PLT donors show no clinically significant PLT count declines, and protein levels remain stable, ensuring apheresis PLT supply.
Area of Science:
- Hematology
- Transfusion Medicine
Background:
- US FDA proposed limiting automated platelet (PLT) collections to 24 components annually.
- Rationale included concerns about frequent PLT collection impacting donor PLT counts.
- Proposed restrictions also included minimal interdonation intervals.
Purpose of the Study:
- To assess the impact of proposed FDA restrictions on PLT collections.
- To evaluate the effect of collection frequency, number of products, and interdonation interval on donor PLT counts.
- To compare protein and albumin levels in frequent PLT donors versus control donors.
Main Methods:
- Analysis of plateletpheresis records with predonation PLT counts.
- Review of donor PLT counts in relation to collection frequency and interdonation intervals.
- Comparison of total protein and albumin levels between frequent PLT donors and whole-blood donors.
Main Results:
- A 24-component limit would necessitate replacing ~20% of donors to maintain supply.
- No clinically significant decrease in donor PLT counts was observed up to 24 collections/year.
- Frequent donors were not deferred for low PLT counts; protein levels were comparable to controls.
Conclusions:
- Proposed FDA restrictions on PLT collections are not needed to prevent thrombocytopenia in frequent donors.
- Restrictions would negatively impact the apheresis PLT supply.
- High-frequency PLT donors maintain adequate protein levels.
Background:
In October 2005, the US Food and Drug Administration (FDA) issued draft guidance on collecting platelets (PLTs) by automated methods. The FDA proposed limiting collections to 24 components, rather than 24 procedures, annually with up to 3 components per procedure. The rationale was from literature suggesting frequent PLT collection resulted in significant declines in donor PLT counts. Additional requirements for minimal interdonation intervals were proposed.
Study Design And Methods:
Plateletpheresis records at a regional blood center with predonation PLT counts were used to assess the impact of the restriction on PLT collections. They were reviewed to demonstrate the effects of collection frequency, number of products collected, and interdonation interval on donor PLT counts. Total protein and albumin levels were compared in a subset of 24-times-per-year PLT donors and control whole-blood donors.
Results:
A limit of 24 components would require replacement of approximately 20 percent of the donor base to recover lost components. No clinically important decrease in PLT counts before donation was seen in donors donating multiple PLT components up to 24 times per year, regardless of interdonation interval. No frequent donor was deferred for a PLT count less than 150 x 10(9) per L. Short interdonation intervals were associated with statistically but not clinically important decreases in PLT counts. Protein levels were not distinguishable between PLT donors and controls.
Conclusion:
The proposed restrictions are not required to prevent thrombocytopenia in frequent PLT donors and would adversely impact the supply of apheresis PLTs. Protein levels are maintained in these high-frequency donors.
More Related Videos
07:27A Simple Protocol for Platelet-mediated Clumping of Plasmodium falciparum-infected Erythrocytes in a Resource Poor Setting
Published on: May 16, 2013
05:49Procoagulant Platelet Characterization by Measuring Phosphatidylserine Exposure and Microvesicle Release from Human Purified Platelets
Published on: November 29, 2024
