This site provides INTERCEPT product information for Health Care Professionals in the United States.

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HEMORRHAGE CONTROL REQUIRES ALL HANDS ON DECK

Dosage

Pre-pooled INTERCEPT® Fibrinogen Complex facilitates transfusion of high doses of fibrinogen from a single container.

Fibrinogen decreases rapidly and significantly in hemorrhage across a variety of clinical settings.1,2

These clinical settings include:

  • Cardiovascular surgery3,4
  • Hemorrhagic trauma2
  • Obstetric hemorrhage5
  • Organ transplant6
  • Disseminated intravascular coagulation (DIC)7
The effective transfusion dose of INTERCEPT Fibrinogen Complex is dependent on the clinical presentation of bleeding, the clinical setting, and the risk and magnitude of bleeding associated with demonstrable or clinically suspected fibrinogen deficiency.

INTERCEPT Fibrinogen Complex retains in vitro functional characteristics 5 days post-thaw8 and pre-pooling facilitates transfusion of high doses of fibrinogen from a single container.*

See the Circular of Information for blood component dosing information9

INTERCEPT FIBRINOGEN COMPLEX # DONORS† MEAN (SD) FIBRINOGEN CONTENT AT THAW (mg) MEAN (SD) FIBRINOGEN CONTENT AT THE END OF 5 DAYS POST THAW (mg)

FC10

2 740 (166) 686 (165)

FC15

4 1556 (248) 1435 (206)

FC20

6 2,220# 2,058#

FC30

8 2845 (618) 2625 (562)

FC40

10 3,700# 3,430#

Mean (±Standard Deviation) from Pathogen Reduced Cryoprecipitated Fibrinogen Complex prepared from whole blood-derived plasma frozen within 24 hours after phlebotomy (PF24) plasma.
†Number of donors based on whole blood donors
#Calculated based on pooling of FC10, SD not available
No in vivo clinical studies have been performed with INTERCEPT Fibrinogen Complex

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*Pooling facilitates transfusion of high doses of fibrinogen from a single container. Fibrinogen content of INTERCEPT Fibrinogen Complex depends on donor plasma fibrinogen levels.

References:

  1. Hiippala ST, Myllyla GJ, Vahtera EM. Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesthesia and analgesia 1995;81:360-5.
  2. Rourke C, Curry N, Khan S, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. Journal of thrombosis and haemostasis. JTH 2012;10:1342-51.
  3. Ranucci M, Pistuddi V, Baryshnikova E, Colella D, Bianchi P. Fibrinogen Levels After Cardiac Surgical Procedures: Association With Postoperative Bleeding, Trigger Values, and Target Values. Ann Thorac Surg 2016;102:78-85.
  4. Karkouti K, Callum J, Crowther MA, et al. The relationship between fibrinogen levels after cardiopulmonary bypass and large volume red cell transfusion in cardiac surgery: an observational study. Anesthesia and analgesia 2013;117:14-22.
  5. Gillissen A, van den Akker T, Caram-Deelder C, et al. Coagulation parameters during the course of severe postpartum hemorrhage: a nationwide retrospective cohort study. Blood advances 2018;2:2433-42.
  6. Abuelkasem E, Tanaka KA, Planinsic RM. Recent update on coagulation management and hemostatic therapies in liver transplantation. Minerva anestesiologica 2018;84:1070-80.
  7. Seligsohn U. Disseminated Intravascular Coagulation. In: Beutler E, Coller BS, Lichtman MA, Kipps TJ, Seligsohn U, eds. Williams Hematology. 6th ed. New York: McGraw Hill; 2001:1677-95.
  8. INTERCEPT Blood System for Cryoprecipitation for the manufacturing of Pathogen Reduced Cryoprecipitated Fibrinogen Complex Package Insert.
  9. AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2024.