Cryoprecipitate prepared from plasma frozen within 24 hours after phlebotomy contains acceptable levels of fibrinogen and VIIIC

Yazer, Mark H.; Triulzi, Darrell J.; Hassett, Andrea Cortese; Kiss, Joseph E.

doi:10.1111/j.1537-2995.2009.02535.x

Cited by 16 publications

(9 citation statements)

References 17 publications

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“…Cryoprecipitate is a concentrated form of fibrinogen derived from plasma. It is administered in pools of 4 to 6 units, with the total amount of fibrinogen per pool typically approaching 2000 mg in approximately 100 mL of plasma . There is approximately 700 mg of fibrinogen in a unit of plasma, assuming there is approximately 3 mg/mL of fibrinogen in a 230‐mL plasma unit, so the number of doses of cryoprecipitate can be adjusted based on the number of plasma units transfused .…”

Section: Discussionmentioning

confidence: 99%

“…It is administered in pools of 4 to 6 units, with the total amount of fibrinogen per pool typically approaching 2000 mg in approximately 100 mL of plasma. 31 There is approximately 700 mg of fibrinogen in a unit of plasma, assuming there is approximately 3 mg/mL of fibrinogen in a 230-mL plasma unit, so the number of doses of cryoprecipitate can be adjusted based on the number of plasma units transfused. 20 Cryoprecipitate should be transfused when a trauma patientʼs fibrinogen concentration is <150 to 200 mg/dL and fibrinogen supplementation is required beyond what is provided in plasma.…”

Section: Discussionmentioning

confidence: 99%

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Confusion surrounding trauma resuscitation and opportunities for clarification

Dunbar

Yazer

2020

Transfusion

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BACKGROUND In the absence of low‐titer group O whole blood, conventional components are often transfused to hemorrhaging trauma patients in a ratio designed to replicate whole blood. However, there is still confusion surrounding how conventional components should be used to support traumatically injured bleeding patients, particularly concerning how platelets should be counted in a ratio‐based approach and when the resuscitation can switch from a ratio‐based to a laboratory‐guided approach. CASE REPORT A traumatically injured patient, who was resuscitated with 10 units of red blood cells (RBCs), 6 units of plasma, 2 units of apheresis platelets, and 5 pools of cryoprecipitate is described. After hemostasis was achieved, and in the setting of an international normalized ratio of 1.2, the clinical team requested 4 additional units of plasma because “the patient was not resuscitated with a 1:1 ratio of RBCs to plasma.” This case illustrates that misconceptions surrounding resuscitation with conventional components may lead to unnecessary transfusions in patients with normal laboratory values who have achieved hemostasis. CONCLUSIONS This report provides clarification as to how conventional components can be used for trauma resuscitation and why there is no need to transfuse additional plasma‐containing components to achieve a desired ratio when the patient is no longer bleeding and laboratory values are within normal limits. Furthermore, each dose of platelets is suspended in roughly the equivalent of 1 additional unit of plasma that should also be considered in the cumulative dose of plasma administered when using a ratio‐based approach.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Confusion surrounding trauma resuscitation and opportunities for clarification

Dunbar

Yazer

2020

Transfusion

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“…Cryoprecipitate contains a higher concentration of fibrinogen than FFP, typically around 15 g/L. 11,12 However, it shares many of the disadvantages of FFP. The risk of viral transmission is similar to that with FFP, but the risk is enhanced by the fact that each pool of cryoprecipitate contains human plasma from multiple donors.…”

Section: Cryoprecipitatementioning

confidence: 99%

Fibrinogen as a Hemostatic Agent

Sørensen

Larsen

Rea

et al. 2012

Semin Thromb Hemost

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Coagulation factor I (fibrinogen) plays an essential role in the hemostatic system by bridging activated platelets and being the key substrate for thrombin in establishing a consolidating fibrin network. Fibrinogen is synthesized in the liver and the plasma concentration is 1 to 5-4.0 g/L. During recent 10 years, fibrinogen has been recognized to play an important role in controlling hemorrhage. Dilutional coagulopathy induced by colloid plasma expanders is characterized by fibrinogen deficiency and dysfunctional fibrin polymerization. Trauma and use of extracorporeal circulation is also known to reduce levels of fibrinogen. A series of laboratory experiments and experimental animal studies have suggested fibrinogen as a potent hemostatic agent. These data are supported by retrospective surveys as well as a series of prospective proof of principal clinical trials. This article provides a description of the biochemistry and mechanisms of fibrinogen as well as the etiology for developing fibrinogen deficiency. Furthermore, it summarizes laboratory and experimental data on the role of fibrinogen in dilutional coagulopathy and addresses laboratory monitoring issues. Finally, it lists retrospective and prospective studies, which have been designed to assess the clinical efficacy and safety of hemostatic intervention with fibrinogen concentrate.

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“…Other studies have demonstrated that CryoAHF manufactured from PF24 yields an acceptable product per AABB standards 5 . Canadian Blood Services (CBS) manufactures cryoprecipitated fibrinogen concentrate (CFC) from the buffy coat method, allowing blood to be held overnight prior to separation and freezing the plasma within 24 h 6 .…”

Section: Introductionmentioning

confidence: 99%

Cryoprecipitated anti‐hemophiliac factor manufactured from plasma frozen within 24 h after phlebotomy meets AABB quality standards

et al. 2022

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Background: Cryoprecipitated antihemophiliac factor (CryoAHF) manufacturing in the US has not kept pace with the increasing demand for hospital transfusion services. Association for Advancement of Blood and Biologics (AABB) and Food and Drug Administration (FDA) require that CryoAHF be manufactured from fresh frozen plasma within 8 h (FFP). We evaluated whether CryoAHF manufactured from plasma frozen within 24 h (PF24) met regulatory quality control (QC) requirements to increase available plasma for CryoAHF.Study Design and Methods: In a "worst-case scenario" feasibility study, we produced 21 single units of CryoAHF from type-O whole blood-derived PF24 frozen between 20 and 24 h after collection. A follow-up QC validation was conducted wherein 69 PF24 units across three sites were manufactured into CryoAHF. Factor VIII (FVIII) and fibrinogen levels were measured.Results: CryoAHF manufactured in our feasibility study from PF24 contained FVIII levels of 208 ± 61 IU (mean ± SD) and 509 ± 152 mg of fibrinogen levels per unit. CryoAHF manufactured in our QC validation from PF24 yielded FVIII levels of 214 ± 58 IU and 607 ± 176 mg of fibrinogen levels per unit. The coagulation factor levels from each of the individual CryoAHF units exceeded the minimum AABB and FDA requirement of ≥80 IU of FVIII per unit and ≥150 mg of fibrinogen per unit. There was no decrease in FVIII or fibrinogen levels in CryoAHF produced from PF24 as compared to historic QC results of CryoAHF produced from FFP. Conclusion: These studies demonstrated that CryoAHF produced from PF24 meets AABB and FDA QC requirements. FDA approved the American Red Cross request to manufacture CryoAHF singles and pools from PF24 as source material.

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Cryoprecipitate prepared from plasma frozen within 24 hours after phlebotomy contains acceptable levels of fibrinogen and VIIIC

Abstract: All units of cryo24 in this pilot study met the current minimum content standards for cryo. While clinical studies of its efficacy are warranted, cryo24's in vitro characteristics are at least equivalent to that of standard cryo.

Cited by 16 publications

References 17 publications

Confusion surrounding trauma resuscitation and opportunities for clarification

Confusion surrounding trauma resuscitation and opportunities for clarification

Fibrinogen as a Hemostatic Agent

Cryoprecipitated anti‐hemophiliac factor manufactured from plasma frozen within 24 h after phlebotomy meets AABB quality standards

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