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Assessing the effectiveness of whole blood-derived platelets stored as a pool: a randomized block noninferiority
N M Heddle1, R J Cook, M A Blajchman
1Department of Medicine and Pathology and Molecular Medicine, McMaster University, and the Canadian Blood Services, Hamilton, Ontario, Canada. heddlen@mcmaster.ca
Insights
Prestorage pooling of platelets (PLTs) for up to 5 days is as effective as individual storage. This method simplifies bacterial detection and maintains posttransfusion corrected count increment (CCI) in patients with thrombocytopenia.
Area of Science:
- Hematology
- Transfusion Medicine
- Blood Banking
Background:
- Prestorage pooling of whole blood-derived platelets (PLTs) offers simplified bacterial detection.
- Evaluating the in vivo efficacy of prestorage pooled PLTs stored up to 5 days is crucial for transfusion practices.
Purpose of the Study:
- To assess the in vivo effect of prestorage pooling of PLTs stored for up to 5 days.
- To compare the corrected count increment (CCI) of pooled versus individually stored PLTs.
Main Methods:
- A randomized block noninferiority design was employed.
- Patients with chemotherapy-induced thrombocytopenia requiring multiple PLT transfusions were included.
- The primary outcome was the 18- to 24-hour posttransfusion CCI, categorized as successful (>4.5) or unsuccessful (<=4.5).
Main Results:
- A total of 189 PLT transfusions were administered to 23 patients.
- The proportion of transfusions achieving a CCI >4.5 was identical for both routine and prestorage pooled PLTs (52.9%).
- No significant difference in mean CCI was observed between pooled and routine storage (-0.45; 95% CI, -2.23 to 1.33).
Conclusions:
- Prestorage pooling of PLTs for up to 5 days yields posttransfusion CCIs not inferior to individually stored PLTs.
- This storage method is a viable alternative for maintaining platelet efficacy.
Background:
Prestorage pooling of whole blood-derived platelets (PLTs) would simplify bacterial detection. This study evaluated the in vivo effect of the prestorage pooling of PLTs stored for up to 5 days, by assessing the corrected count increment (CCI) 18 to 24 hours after transfusion of the product.
Study Design And Methods:
A randomized block noninferiority design was used. Eligible patients had chemotherapy-induced thrombocytopenia and were considered likely to need at least six PLT transfusions. For every block of two transfusion events, one consisted of PLTs stored individually and then pooled before transfusion, and the other was a product pooled before storage. The primary outcome was categorized as a successful (>4.5) or unsuccessful (
Results:
Twenty-three eligible patients received a total of 189 PLT transfusions. The median number of PLT transfusions was 7 (range, 0-27). Eighty-five complete transfusion pairs were used in the primary analysis. The proportions of transfusions leading to a CCI of greater than 4.5 was identical for both routine and PLTs pooled before storage (45/85=52.9%; relative risk, 1.00; lower limit of the one-sided 95% confidence interval [CI], 0.83). The estimate of the mean difference in CCI between pooled and routine storage (pooled-routine) was -0.45 (95% CI, -2.23 to 1.33; p=0.63).
Conclusion:
These results provide evidence that storage of PLTs as a pool for up to 5 days results in posttransfusion CCIs that are not inferior to PLTs stored individually.
