Reduce Patient Risk of Transfusion Transmitted Infection

Cerus INTECEPT Pathogen Reduced Platelets

The INTERCEPT® Blood System for platelets provides robust, broad-spectrum inactivation, reducing the risks of TTI, including sepsis. Additionally, the INTERCEPT Blood System inactivates donor T-cells, and is an FDA approved alternative to gamma irradiation for the prevention of transfusion-associated graft-versus-host disease (TA-GVHD). The safety and efficacy of INTERCEPT treated platelets (“INTERCEPT Platelets”) has been supported by hemovigilance programs and several clinical trials.

INTERCEPT Platelets

Demonstrated prevention of septic reactions in routine use

Hemovigilance (HV) programs provide a comprehensive view of transfusions and potential adverse events via the surveillance of blood donations in routine use settings. Over 875,000 INTERCEPT Platelets have been transfused to patients in these countries, with no reported transfusion-transmitted infections or sepsis-related fatalities to-date.

  Conventional Platelets INTERCEPT Platelets
HV Data STRs (Deaths) STRs (Deaths)
France1,2

53 (9)
2006-2017*
0 (0)
2006-2017
Switzerland3,4 16 (3)
2005-2011**
0 (0)
2011-2018
Belgium5 7 (0)
2009-2015***
0 (0)
2009-2016
Total 76 (12) 0 (0)

STR= Septic Transfusion Reaction
* France transitioned to 100% INTERCEPT treated platelets in 2018
** Switzerland transitioned to 100% INTERCEPT treated platelets in 2011
*** Belgium transistioned to 100% INTERCEPT treated platelets in 2015

Clinical trials leading to FDA approval

The INTERCEPT Blood System has been evaluated in numerous clinical trials comprised of over 1000 subjects that received INTERCEPT Platelets. Primary endpoints were met in the controlled, randomized clinical trials, including corrected count increments (CCI) and bleeding criteria, both of which are measures of hemostatic efficacy. The frequency of acute transfusion reactions (ATRs) was assessed in three observational studies.

Study Description Patients Design Primary Endpoint Primary Endpoint Met?
Viability of INTERCEPT Platelets, clearance of amotosalen, healthy patients8,9 65 Randomized, single-blind, cross-over Recovery/survival, clearance of amotosalen checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients10 645 Randomized, double-blind, parallel WHO Grade 2 bleeding checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients11 43 Randomized, double-blind, parallel 1 hour CCI checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients12 32 Randomized, double-blind, cross-over Bleeding time checkmark
Safety of INTERCEPT Routine setting13 51 Single-arm, open label Frequency of acute transfusion
reactions was 1.6%
Safety of INTERCEPT Routine setting14 46 Single-arm, open label Frequency of acute transfusion
reactions was 2%
Safety of INTERCEPT Routine setting15 169 Single-arm, open label Frequency of acute transfusion
reactions was 2.4%

 


  1. Cazenave, JP, H Isola, et al., Pathogen Inactivation of Platelets, in Platelet Transfusion Therapy, AABB Press: Bethesda, MD 2013; 19-176
  2. French National Agency for Medicine and Health Product Safety/ANSM, Hemovigilance Activity Reports, 2009–2017.
  3. SwissMedic Haemovigilance Annual Reports, 2005–2017.
  4. Jutzi M. et al. Transfus Med Hemother 2018;45:151-6.
  5. Annual Report 2018. Swiss Transfusion SRC, 2018.
  6.  Benjamin et al. Transfusion 2017;57:2946-57
  7. AFMPS Hémovigilance Rapport annuel: Belgium. 2016.
  8. Snyder E et al. Transfusion 2004;44:1732-1740.
  9. Corash L et al. Transfusion 2000;40(S10):137.
  10. McCullough et al. Blood 2004;104(5):1534-1541.
  11. Janetzko et al. Transfusion 2005;45:1443-1452.
  12. Slichter SJ et al. Transfusion 2006;46:731-740.
  13. Schlenke P et al. Ann Hematol 2011;90(12):1457-1465.
  14. Infanti L et al. Transfus Apher Sci 2011;45(2):175-181.
  15. The INTERCEPT Blood System for Platelets - Dual Storage Set Package Insert, March 15, 2016