A global initiative on local preparation of virus inactivated cryoprecipitate in developing countries

In developing countries, treatment of patients with bleeding disorders is inadequate or absent and the dramatic situation has not changed significantly during the past 20 to 30 years despite several initiatives set up by different national and international organizations. Past experience has shown that industrially manufactured clotting factor concentrates cannot solve these problems in developing countries, if they are used as the sole means in the treatment of patients with bleeding disorders. Recently, significant developments have occurred which have the potential to change the disastrous situation in therapy delivery to “hemophiliacs” in developing countries: blood systems (with blood services and blood centers) in many resource limited countries have tangibly improved and novel technologies for viral inactivation of blood components have been developed and are marketed [amotosalen, riboflavin, solvent-detergent (SD), etc.]. In a few developing countries, local preparation of viral inactivated cryoprecipitate (Cryo-VI) has been introduced and Cryo-VI has proven to be a safe, effective therapeutic for patients with bleeding disorders, at an affordable cost. But the use of VI-technology to render cryoprecipitate safe remains very limited; therefore, major coordinated actions are needed to promote Cryo-VI in developing countries and to facilitate implementation of local preparation of safe cryoprecipitate. Therefore, a Global Initiative on “local preparation of viral inactivated cryoprecipitate in developing countries” (“Local Cryo-VI in l-HDI”) has been launched to improve treatment of patients with bleeding disorders: it is based on collaboration with international partnering organizations (like WHO, ISBT and others) and national stakeholders (e.g., competent authorities, blood suppliers, patient associations). The Global Initiative consists of six core interventions, flanked by additional activities: revise and update existing standards and guidelines on “anti-hemophilic” treatment; give high priority in policies and strategies to “Local Cryo-VI in l-HDI”; organize strong advocacy; run a Pilot Project (PP) in several pilot sites; establish an expansion programme; support activities for implementation and sustainability of “Local Cryo-VI in l-HDI”. It is complementary to existing relief activities (e.g., product donations) and will result in additional supply of safe and effective haemostatic products to treat patients with bleeding disorders in developing countries. It will also contribute to significantly lower the incidence of inhibitors in previously untreated patients with hemophilia A.