INTERCEPT Blood System for Platelets, pathogen reduction system:

Proven safe and effective

The INTERCEPT Blood System for platelets provides robust, broad-spectrum inactivation, reducing the risks of TTI, including sepsis. In addition, the number of T-cells is reduced to a level that potentially reduces the risk of transfusion-associated graft-versus-host disease (TA-GVHD). The safety and efficacy of INTERCEPT Blood System processed 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 300,000 INTERCEPT Blood System processed platelet units have been transfused in French and Swiss national HV programs, with no reported transfusion-transmitted infections or sepsis-related fatalities to-date.1

  Conventional Platelets INTERCEPT Platelets
HV
Program
Platelet Units
Transfused (n)
Transfusion
Transmitted Infections
(Fatalities)
Platelet Units
Transfused
(n)
Transfusion
Transmitted Infections
France1,2
2006-2014
2,299,334 49 (8) 180,762 0
Switzerland3
2010-2014
36,500 1 (0) 130,843 0
Total 2,335,834 50 (8) 311,605 0

Clinical trials

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 patients4,5 65 Randomized, single-blind, cross-over Recovery/survival, clearance of amotosalen checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients6 645 Randomized, double-blind, parallel WHO Grade 2 bleeding checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients7 43 Randomized, double-blind, parallel 1 hour CCI checkmark
Safety/efficacy of INTERCEPT Platelets, thrombocytopenic patients8 32 Randomized, double-blind, cross-over Bleeding time checkmark
Safety of INTERCEPT Routine setting9 51 Single-arm, open label Frequency of acute transfusion
reactions was 1.6%
Safety of INTERCEPT Routine setting10 46 Single-arm, open label Frequency of acute transfusion
reactions was 2%
Safety of INTERCEPT Routine setting11 169 Single-arm, open label Frequency of acute transfusion
reactions was 2.4%

References

  1. Sweeney J et al. Platelet Transfusion Therapy. Bethesda: AABB Press, 2013
  2. Agence Francaise de Securite Sanitaire des Produits de Sante, Rapport Annuel Hemovigilance 2009-2014.
  3. Swissmedic, Haemovigilance Annual Report, 2010-2014.
  4. Snyder E et al. Transfusion 2004;44:1732-1740.
  5. Corash L et al. Transfusion 2000;40(S10):137.
  6. McCullough et al. Blood 2004;104(5):1534-1541.
  7. Janetzko et al. Transfusion 2005;45:1443-1452.
  8. Slichter SJ et al. Transfusion 2006;46:731-740.
  9. Schlenke P et al. Ann Hematol 2011;90(12):1457-1465.
  10. Infanti L et al. Transfus Apher Sci 2011;45(2):175-181.
  11. The INTERCEPT Blood System for Platelets - Dual Storage Set Package Insert, March 15, 2016
*Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.