Dataset Information

Phased implementation of pathogen-reduced platelets in a health system facilitates increased manufacturing at the blood center.

ABSTRACT:

Background

Pathogen reduction treatment (PRT) reduces the risk of transfusion-transmitted infections from established and emerging organisms. Manufacturing, however, is complex. In our university health system, we phased in pathogen-reduced platelets (PR PLTs) by patient population. We then assessed the implementation strategy and investigated factors in the supply chain that prevented us from meeting the goal of providing greater than 90% PR PLTs within 6 months.

Study design and methods

In Phase 1, PR PLTs were provided in the outpatient cancer center. Phase 2 added inpatients undergoing bone marrow transplantation, and Phase 3 included all patients. In Phase 4, the blood center implemented manufacturing optimization strategies. Product supply and usage during the first 23?months after implementation were evaluated. Investigation of the supply chain included analysis of (1) the number of in-state hospitals receiving PR PLTs; (2) the fraction of products eligible for PRT before and after manufacturing improvements.

Results

During Phases 1 and 2, PR products comprised 44% and 53% of PLTs transfused in the phased-in areas. At 6 months, 41% of PLTs were PR, and at 23?months, 92%. The fraction of PR PLTs transfused in our system correlated logarithmically with the number of in-state hospitals receiving them (R² = 0.71) and the number of PR PLTs sold to those hospitals (R² = 0.80).

Conclusion

Phased implementation is a practical and ethical way to introduce PR PLTs in a health system and facilitates scalability at the blood center. Widespread availability of PR products may require collective action and can be increased by optimization strategies during manufacturing.

SUBMITTER: Allen ES

PROVIDER: S-EPMC6852374 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Phased implementation of pathogen-reduced platelets in a health system facilitates increased manufacturing at the blood center.

Allen Elizabeth S ES Vincent Colleen C Reeve David A DA Kopko Patricia M PM

Transfusion 20190813 10

<h4>Background</h4>Pathogen reduction treatment (PRT) reduces the risk of transfusion-transmitted infections from established and emerging organisms. Manufacturing, however, is complex. In our university health system, we phased in pathogen-reduced platelets (PR PLTs) by patient population. We then assessed the implementation strategy and investigated factors in the supply chain that prevented us from meeting the goal of providing greater than 90% PR PLTs within 6 months.<h4>Study design and met ...[more]

PMID: 31408203

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Project description:ImportancePathogen reduction of platelet concentrates may reduce transfusion-transmitted infections but is associated with qualitative impairment, which could have clinical significance with regard to platelet hemostatic capacity.ObjectiveTo compare the effectiveness of platelets in additive solution treated with amotosalen-UV-A vs untreated platelets in plasma or in additive solution in patients with thrombocytopenia and hematologic malignancies.Design, setting, and participantsThe Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) study was a randomized, noninferiority, 3-arm clinical trial performed from May 16, 2013, through January 21, 2016, at 13 French tertiary university hospitals. Clinical signs of bleeding were assessed daily until the end of aplasia, transfer to another department, need for a specific platelet product, or 30 days after enrollment. Consecutive adult patients with bone marrow aplasia, expected hospital stay of more than 10 days, and expected need of platelet transfusions were included.InterventionsAt least 1 transfusion of platelets in additive solution with amotosalen-UV-A treatment, in plasma, or in additive solution.Main outcomes and measuresThe proportion of patients with grade 2 or higher bleeding as defined by World Health Organization criteria.ResultsAmong 790 evaluable patients (mean [SD] age, 55 [13.4] years; 458 men [58.0%]), the primary end point was observed in 126 receiving pathogen-reduced platelets in additive solution (47.9%; 95% CI, 41.9%-54.0%), 114 receiving platelets in plasma (43.5%; 95% CI, 37.5%-49.5%), and 120 receiving platelets in additive solution (45.3%; 95% CI, 39.3%-51.3%). With a per-protocol population with a prespecified margin of 12.5%, noninferiority was not achieved when pathogen-reduced platelets in additive solution were compared with platelets in plasma (4.4%; 95% CI, -4.1% to 12.9%) but was achieved when the pathogen-reduced platelets were compared with platelets in additive solution (2.6%; 95% CI, -5.9% to 11.1%). The proportion of patients with grade 3 or 4 bleeding was not different among treatment arms.Conclusions and relevanceAlthough the hemostatic efficacy of pathogen-reduced platelets in thrombopenic patients with hematologic malignancies was noninferior to platelets in additive solution, such noninferiority was not achieved when comparing pathogen-reduced platelets with platelets in plasma.Trial registrationclinicaltrials.gov Identifier: NCT01789762.

Dataset Information

Phased implementation of pathogen-reduced platelets in a health system facilitates increased manufacturing at the blood center.

Background

Study design and methods

Results

Conclusion

Publications

Phased implementation of pathogen-reduced platelets in a health system facilitates increased manufacturing at the blood center.

Similar Datasets

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