Cold platelets for trauma-associated bleeding: Regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg"

James R. Stubbs, Sheryl A. Tran, Richard L. Emery, Scott A. Hammel, De Anna L. Haugen, Martin D. Zielinski, Scott P. Zietlow, Donald Jenkins

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

BACKGROUND: Laboratory and clinical evidence suggest that cold-stored platelets (CS-PLTs) might be preferable to room temperature platelets (RT-PLTs) for active bleeding. Ease of prehospital use plus potential hemostatic superiority led our facility to pursue approval of CS-PLTs for actively bleeding trauma patients. STUDY DESIGN AND METHODS: From November 18, 2013, through October 8, 2015, correspondence was exchanged between our facility, the AABB, and the US Food and Drug Administration (FDA). An initial AABB variance request was for 5-day CS-PLTs without agitation. The AABB deferred its decision pending FDA approval to use our platelet (PLT) bags for CS-PLTs. On March 27, 2015, the FDA approved 3-day CS-PLTs without agitation. On October 8, 2015, the AABB approved 3-day CS-PLTs without agitation and without bacterial testing for actively bleeding trauma patients. Our facility's goal is to carry CS-PLTs on air ambulances. RESULTS: CS-PLTs have been used for trauma patients at our facility since October 2015. As of August 2016, a total of 21 (19.1%) of 119 CS-PLTs have been transfused. The short 3-day storage period combined with the formation of clots in plasma-rich CS-PLTs during storage have been the major causes of a high (80.9%) discard rate. CONCLUSION: In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.

Original languageEnglish (US)
JournalTransfusion
DOIs
StateAccepted/In press - 2017

Fingerprint

Accreditation
Blood Platelets
Hemorrhage
Wounds and Injuries
United States Food and Drug Administration
Air Ambulances
Plasma Gases
Drug Approval
Hemostatics

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

Cite this

Stubbs, J. R., Tran, S. A., Emery, R. L., Hammel, S. A., Haugen, D. A. L., Zielinski, M. D., ... Jenkins, D. (Accepted/In press). Cold platelets for trauma-associated bleeding: Regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg". Transfusion. https://doi.org/10.1111/trf.14303

Cold platelets for trauma-associated bleeding : Regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg". / Stubbs, James R.; Tran, Sheryl A.; Emery, Richard L.; Hammel, Scott A.; Haugen, De Anna L.; Zielinski, Martin D.; Zietlow, Scott P.; Jenkins, Donald.

In: Transfusion, 2017.

Research output: Contribution to journalArticle

Stubbs, James R. ; Tran, Sheryl A. ; Emery, Richard L. ; Hammel, Scott A. ; Haugen, De Anna L. ; Zielinski, Martin D. ; Zietlow, Scott P. ; Jenkins, Donald. / Cold platelets for trauma-associated bleeding : Regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg". In: Transfusion. 2017.
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abstract = "BACKGROUND: Laboratory and clinical evidence suggest that cold-stored platelets (CS-PLTs) might be preferable to room temperature platelets (RT-PLTs) for active bleeding. Ease of prehospital use plus potential hemostatic superiority led our facility to pursue approval of CS-PLTs for actively bleeding trauma patients. STUDY DESIGN AND METHODS: From November 18, 2013, through October 8, 2015, correspondence was exchanged between our facility, the AABB, and the US Food and Drug Administration (FDA). An initial AABB variance request was for 5-day CS-PLTs without agitation. The AABB deferred its decision pending FDA approval to use our platelet (PLT) bags for CS-PLTs. On March 27, 2015, the FDA approved 3-day CS-PLTs without agitation. On October 8, 2015, the AABB approved 3-day CS-PLTs without agitation and without bacterial testing for actively bleeding trauma patients. Our facility's goal is to carry CS-PLTs on air ambulances. RESULTS: CS-PLTs have been used for trauma patients at our facility since October 2015. As of August 2016, a total of 21 (19.1{\%}) of 119 CS-PLTs have been transfused. The short 3-day storage period combined with the formation of clots in plasma-rich CS-PLTs during storage have been the major causes of a high (80.9{\%}) discard rate. CONCLUSION: In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.",
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T2 - Regulatory approval, accreditation approval, and practice implementation-just the "tip of the iceberg"

AU - Stubbs, James R.

AU - Tran, Sheryl A.

AU - Emery, Richard L.

AU - Hammel, Scott A.

AU - Haugen, De Anna L.

AU - Zielinski, Martin D.

AU - Zietlow, Scott P.

AU - Jenkins, Donald

PY - 2017

Y1 - 2017

N2 - BACKGROUND: Laboratory and clinical evidence suggest that cold-stored platelets (CS-PLTs) might be preferable to room temperature platelets (RT-PLTs) for active bleeding. Ease of prehospital use plus potential hemostatic superiority led our facility to pursue approval of CS-PLTs for actively bleeding trauma patients. STUDY DESIGN AND METHODS: From November 18, 2013, through October 8, 2015, correspondence was exchanged between our facility, the AABB, and the US Food and Drug Administration (FDA). An initial AABB variance request was for 5-day CS-PLTs without agitation. The AABB deferred its decision pending FDA approval to use our platelet (PLT) bags for CS-PLTs. On March 27, 2015, the FDA approved 3-day CS-PLTs without agitation. On October 8, 2015, the AABB approved 3-day CS-PLTs without agitation and without bacterial testing for actively bleeding trauma patients. Our facility's goal is to carry CS-PLTs on air ambulances. RESULTS: CS-PLTs have been used for trauma patients at our facility since October 2015. As of August 2016, a total of 21 (19.1%) of 119 CS-PLTs have been transfused. The short 3-day storage period combined with the formation of clots in plasma-rich CS-PLTs during storage have been the major causes of a high (80.9%) discard rate. CONCLUSION: In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.

AB - BACKGROUND: Laboratory and clinical evidence suggest that cold-stored platelets (CS-PLTs) might be preferable to room temperature platelets (RT-PLTs) for active bleeding. Ease of prehospital use plus potential hemostatic superiority led our facility to pursue approval of CS-PLTs for actively bleeding trauma patients. STUDY DESIGN AND METHODS: From November 18, 2013, through October 8, 2015, correspondence was exchanged between our facility, the AABB, and the US Food and Drug Administration (FDA). An initial AABB variance request was for 5-day CS-PLTs without agitation. The AABB deferred its decision pending FDA approval to use our platelet (PLT) bags for CS-PLTs. On March 27, 2015, the FDA approved 3-day CS-PLTs without agitation. On October 8, 2015, the AABB approved 3-day CS-PLTs without agitation and without bacterial testing for actively bleeding trauma patients. Our facility's goal is to carry CS-PLTs on air ambulances. RESULTS: CS-PLTs have been used for trauma patients at our facility since October 2015. As of August 2016, a total of 21 (19.1%) of 119 CS-PLTs have been transfused. The short 3-day storage period combined with the formation of clots in plasma-rich CS-PLTs during storage have been the major causes of a high (80.9%) discard rate. CONCLUSION: In the future, pathogen-reduced (PR), PLT additive solution (PAS) CS-PLTs seem more practical due to low risks of bacterial contamination and storage-related clotting. This should make longer storage of CS-PLTs feasible (e.g., 10 days or more). With a longer shelf life, PR PAS CS-PLTs could potentially be used in a wider range of patient populations.

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