Safety, Efficacy, and HemovigilanceReduce Patient Risk of Transfusion Transmitted Infection
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.
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 reduced transfusion-transmitted infections and no fatalities attributed to INTERCEPT Platelets to-date.
|Conventional Platelets||INTERCEPT Platelets|
|HV Data||Septic Transfusion Reactions (Fatalities)||Septic Transfusion Reactions (Fatalities)|
|53 (9)||0 (0)|
|16 (3)||0 (0)|
|9 (0)||0 (0)|
|Total||78 (12)||0 (0)|
** Switzerland transitioned to 100% INTERCEPT treated platelets in 2011
*** Belgium transitioned 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.
|Primary Endpoint Met?|
|Viability of INTERCEPT Platelets, clearance of amotosalen, healthy patients8,9||65||Randomized, single-blind, cross-over||Recovery/survival, clearance of amotosalen|
|Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients10||645||Randomized, double-blind, parallel||WHO Grade 2 bleeding|
|Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients11||43||Randomized, double-blind, parallel||1 hour CCI|
|Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients12||32||Randomized, double-blind, cross-over||Bleeding time|
|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, 2009–2019. 3. SwissMedic Haemovigilance Annual Reports, 2005–2019. 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.