An Active Hemovigilance Program Characterizing the Safety Profile of 7,437 Platelet Transfusions Prepared with Photochemical Treatment (INTERCEPT™).

Background. Inactivation of pathogens and leukocytes in platelet components using amotosalen and UVA light (INTERCEPT) is in routine use in some European blood centers. An active hemovigilance program was implemented to characterize the safety profile of INTERCEPT platelets (PLT) in a broad patient population. The results of the first 5,106 transfusions (txn) have been reported (

Methods. Apheresis or buffy coat PLT were leukoreduced, suspended in ∼35% plasma and 65% Intersol™, treated with the INTERCEPT system and stored for up to 7 days. INTERCEPT treatment replaced bacterial screening and gamma irradiation. Blood centers using INTERCEPT PLT were requested to complete a data form after txn. The focus of the study was on response to txn occurring within the first 24 hr of txn. Investigators recorded: patient (pt) demographics, primary diagnosis and therapy, and type of PLT product. For adverse events, the following data were collected: time of event following txn, clinical description, objective clinical parameters (vital signs), results from clinical and laboratory tests (radiographs, bacterial cultures), event severity (grade 0–4), serious or non-serious nature, and causal relationship to txn (unrelated, probably unrelated, possibly related, probably related, or related).

Results. A total of 7,437 PLT txn were administered to 1,400 pts. The mean age of pts was 60 (range <1–96) years. 53.4% of the pts had hematologic diseases and required conventional chemotherapy(44.8%) and stem cell transplant(8.6%). PLT txn associated with “related” (possibly related, probably related, or related) adverse events following INTERCEPT PLT txn were infrequent (n=55, 0.7%) and most reactions were of grade 1 (absence of immediate or long-term life-threatening medical conditions). 45 pts(3.2%) experienced at least one event following one or more INTERCEPT txn. Adverse events classified as “related” to the INTERCEPT PLT txn occurred only in 39(2.8%) of the 45 pts. The events were generally representative of the events expected with PLT txn. The most frequently reported signs/symptoms were chills, fever, urticaria, dyspnea, nausea, and vomiting. Only 5 events were considered as severe (≥grade 2), however, no causal relationship to INTERCEPT PLT txn was found. Repeated exposure to INTERCEPT PLT did not increase the likelihood of a txn reaction. No cases of Txn Related Acute Lung Injury and no deaths due to an INTERCEPT txn were reported.

Conclusions. In this cohort study, 99.3% of INTERCEPT PLT txn were without reported txn reactions. Only 2.8% of pts with reported adverse reactions had a possible, probable or related attribution to PLT txn. These results are consistent with those reported in the HV1 study and further suggest that routine txn of INTERCEPT PLT is well tolerated in a wide range of pts. Adverse events following INTERCEPT PLT txn classified as related to txn were infrequent and most were of mild severity.