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INTERCEPT® Fibrinogen Complex Implementation: A View from Trauma Anesthesiology at Barnes-Jewish Hospital

Timely administration of fibrinogen and other key clotting factors is essential to controlling hemorrhage, yet access to fibrinogen sources (such as cryo AHF and fibrinogen concentrates) can be challenging given their long wait times and short shelf life.

This webinar discusses the role of fibrinogen during trauma-induced coagulopathy, fibrinogen replacement strategies, and Barnes-Jewish Hospital’s experience with INTERCEPT® Fibrinogen Complex, and how IFC is immediately available to improve patient access.

Justin G. Knittel, MD
Division Chief, Trauma Anesthesiology
Associate Professor, Anesthesiology
Washington University School of Medicine St. Louis
Barnes-Jewish Hospital
St. Louis, Missouri

Dr. Justin Knittel is the Division Chief of Trauma Anesthesiology and an Associate Professor of Anesthesiology at Washington University School of Medicine St. Louis and Barnes-Jewish Hospital in St. Louis Missouri.

He earned his bachelor’s degree from the University of Wisconsin-Madison and his medical degree from Case Western Reserve University School of Medicine. He completed an intern year in General Surgery at Mount Sinai in New York City, his residency in Anesthesiology at Massachusetts General Hospital and his fellowship in Critical Care in the Department of Anesthesiology at WashU Medicine in 2013. He then joined the WashU Medicine faculty in 2014.

Dr. Knittel is a distinguished clinician and leader with a notable track record of service and dedication to the department and beyond, including serving as trauma fellowship director and resident education director for the Surgical ICU since 2017. Dr. Knittel also volunteers in the Ukraine with Doctors Collaborating to Help Children.

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Runtime: 33 min

INTERCEPT® Blood System for Platelets Pathogen Reduction System

INTENDED USE

The INTERCEPT Blood System for Platelets is intended to be used for ex vivo preparation of pathogen-reduced Amicus apheresis platelet components suspended in 65% PAS-3/35% plasma, and Trima apheresis platelet components suspended in 100% plasma in order to reduce the risk of transfusion-transmitted infection (TTI), including sepsis, and as an alternative to gamma irradiation for prevention of transfusion-associated graft versus host disease (TA-GVHD).

CONTRAINDICATIONS

Contraindicated for preparation of platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens.

Contraindicated for preparation of platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only INTERCEPT Processing Sets for platelets are approved for use in the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any platelet components not exposed to the complete INT100 illumination process.

Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

INTERCEPT® Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex

INTENDED USE
The INTERCEPT Blood System for Cryoprecipitation is intended to provide a functionally closed system for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex.

Pathogen Reduced Cryoprecipitated Fibrinogen Complex is indicated for:

Treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.
Control of bleeding when recombinant and/or specific virally inactivated preparations of factor XIII or von Willebrand factor (vWF) are not available.
Second-line therapy for von Willebrand disease (vWD).
Control of uremic bleeding after other treatment modalities have failed.

Limitations of Use: Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used for replacement of factor VIII.

CONTRAINDICATIONS

Contraindicated for preparation of blood components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens.

Contraindicated for preparation of blood components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only the INTERCEPT Blood System for Cryoprecipitation is approved for use to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex.

For management of patients with vWD or factor XIII deficiency, Pathogen Reduced Cryoprecipitated Fibrinogen Complex should not be used if recombinant or specific virally-inactivated factor preparations are available. In emergent situations, if recombinant or specific virally-inactivated factor preparations are not available, Pathogen Reduced Cryoprecipitated Fibrinogen Complex may be administered.