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INTERCEPT Fibrinogen Complex: Initial Experience at UF Health

Trauma, CV, and high-risk OB centers across the U.S. are implementing Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex or IFC), to ensure fibrinogen and other key clotting factors are ready to transfuse in the first minutes of hemorrhage treatment. In this symposium, Dr. Erin Vanzant will discuss the importance of early fibrinogen supplementation in traumatic hemorrhage, and how IFC’s 5-day post-thaw shelf life allows them to achieve this treatment goal while decreasing product waste, and improving blood availability for patients in need.

Erin Vanzant, MD
Associate Trauma Medical Director
Director of Transfusion Medicine Fellowship
UF Health Shands Hospital
Gainesville, Florida

Dr. Erin Vanzant earned her medical degree from the University of Texas School of Medicine at San Antonio and completed her general surgery residency training at the University of Florida College of Medicine where she was recognized as the Distinguished Resident Dedicated to Teaching. She also completed fellowships in surgical critical care and acute care surgery at the University of Florida.

She is a past, peer-selected member of the UF Health Department of Surgery Education/Program Evaluation Committee, as well as the Quality Improvement Committee. Dr. Vanzant has also completed multiple other training programs such as Advanced Surgical Skills for Exposure in Trauma and Advanced Trauma Life Support.

In 2013, Dr. Vanzant was the recipient of the Collaborative Research Forum Scholarship at the 5th Annual Collaborative Research Forum in Phoenix, Arizona. In the same year, she was awarded the Shock Society Travel Grant for New Investigators at the 37th Annual Conference on Shock in San Diego, California. She has delivered multiple presentations, her most recent being the Diagnosis and Management of Acute Pulmonary Embolism.

Watch the Replay
Runtime: 14 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 less than 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 (INTERCEPT® Fibrinogen Complex, IFC)

INDICATIONS FOR USE

PATHOGEN REDUCED CRYOPRECIPITATED FIBRINOGEN COMPLEX

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 less than 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.