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Implementing the Use of INTERCEPT® Fibrinogen Complex (IFC) in the Pediatric Setting

Presented during the SABM 2022 Annual Meeting:
Improved Blood Availability with the INTERCEPT® Blood System, Pathogen Reduction System

Inventory management for platelet components and fibrinogen sources (such as cryoprecipitated Antihemophilic Factor, or cryo AHF) can be challenging given their short shelf-life. Timely administration of platelets and fibrinogen are essential to prevent delays in treatments and surgeries. This workshop describes how Pathogen Reduced Platelets (also known as INTERCEPT® Platelets) and Pathogen Reduced Cryoprecipitated Fibrinogen Complex (also known as INTERCEPT® Fibrinogen Complex) improve blood availability for patients in need.

Presented by:
Sheri Goertzen, MLS(ASCP)BB, CLS(CA), CQA(ASQ)
Supervisor
Transfusion Service
Valley Children’s Hospital & Healthcare
Madera, California

Sheri Goertzen started her medical technologist career as a blood banker at a large regional medical center in Fresno, California where she served for 11 years. She then became the Transfusion Service Supervisor at Valley Children’s Hospital and has been there for the last 31 years. During this time, Sheri has been very active in AABB, serving as a lead assessor, as well as being a member and chair of various committees that focus on accreditation and education. She served on the BB/TS Standards Committee, and is currently a member of the AABB eLearning and Annual Meeting Education Committees. Additionally, Sheri has been a reviewer of abstracts for AABB and has contributed multiple articles as well as being featured in the AABB News publication.

Sheri enjoys teaching and is very involved at Valley Children’s Hospital in the education of the CLS interns, nursing staff, and medical staff. She is also an active member of numerous hospital committees including the Transfusion Committee, Pharmacy, and Patient Safety Committee.

Watch the Replay
Runtime: 24 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.