Tolerance of platelet concentrates treated with UVC-light only for pathogen reduction--a phase I clinical trial.

BACKGROUND: The THERAFLEX UV-Platelets pathogen reduction system for platelet concentrates (PCs) operates with ultraviolet C light (UVC; 254 nm) only without addition of photosensitizers. This phase I study evaluated safety and tolerability of autologous UVC-irradiated PCs in healthy volunteers. METHODS: Eleven volunteers underwent two single (series 1 and 2) and one double apheresis (series 3). PCs were treated with UVC, stored for 48 h and retransfused in a dose-escalation scheme: 12·5, 25% and 50% of a PC (series 1); one complete PC (series 2); two PCs (series 3). Platelet counts, fibrinogen, activated partial thromboplastin time, prothrombin time, D-dimer, standard haematology, temperature, heart rate, blood pressure and clinical chemistry parameters were measured. One- and 24-h corrected count increments were determined in series 2 and 3. Platelet-specific antibodies were assessed before and at the end of the study. RESULTS: Neither adverse reactions related to transfusions nor antibodies against UVC-treated platelets were observed. Corrected count increments did not differ between series 2 and 3. CONCLUSIONS: Repeated transfusions of autologous UVC-treated PCs were well tolerated and did not induce antibody responses in all volunteers studied. EudraCT No. 2010-023404-26.

Polymorphism of the IL-8 gene and the risk of ovarian cancer.

Ovarian cancer still represents a challenge in gynecological oncology. Most patients are diagnosed in an advanced tumor stage. No specific screening or prevention strategies for ovarian cancer exist as of yet. Interleukin 8 (IL-8) is a pro-inflammatory chemokine known for its angiogenetic activity, and is supposedly responsible for tumor-associated angiogenesis in several malignant tumors. The aim of the study was to investigate the susceptibility of patients with an IL-8 gene polymorphism to developing ovarian cancer. Four single nucleotide polymorphisms (SNPs) (IL-8 -251, IL-8 +781, IL-8 +1633 and IL-8 +2767) of the IL-8 gene were screened, using the PCR method in 268 patients with ovarian cancer and 426 healthy women as a control group. Significant associations were noted in patients with the IL-8 +781 (T/T) genotype (p=0.0048) with increased frequencies of ovarian cancer, while women with the IL-8 +781 (C/C) allele suffer from ovarian cancer significantly less frequently (p=0.0003). Furthermore, the IL-8 +2767 (T/T) genotype is also associated with a higher risk of ovarian cancer (p=0.0177). Our results indicate, for the first time, that IL-8 polymorphism is associated with ovarian cancer.

Evaluation of a new German blood donor questionnaire.

BACKGROUND AND OBJECTIVES: In Germany, blood donors must complete a donor history questionnaire (DHQ). In 2011, a new standardized DHQ for Germany was proposed which included questions about sexual risk behaviour that raised concerns about acceptance by donors. MATERIALS AND METHODS: We assessed the acceptability and ease of use of the new DHQ in two German donor populations, by asking the donors to complete a paper survey evaluating the design and clarity of the questions of the new DHQ with a focus on the questions addressing sexual risk behaviour. RESULTS: In Greifswald, 2000 donors (mean age 32 ± 12 years) participated, and in Hagen 2088 donors (mean age 48 ± 14 years). Ratings between the two populations showed only minor differences. Donors reported that the questions in the new DHQ were understandable and clearly structured. Perception of comfort level with questions addressing sexual risk behaviour differed significantly depending on donor characteristics such as age, gender and educational level. Overall, the new DHQ seems to deter approximately 5% of potential donors from blood donation. CONCLUSION: The new DHQ was acceptable to the vast majority of donors. Potential donors who were older, male gender and less educated were most at risk of refusing to donate and may benefit from educational interventions.

Factors influencing confidential unit exclusions in blood donors.

BACKGROUND AND OBJECTIVE: In many countries blood donors can exclude their donated blood from being transfused in a confidential unit exclusion (CUE) process. We aimed to identify characteristics which might influence the decision for CUE. STUDY DESIGN AND METHODS: In a 3-step approach we first enrolled 29 German blood donation centers in 2005 and addressed how the clarity of different CUE forms applied in these centers was rated by first time blood donors and also assessed three newly designed CUE forms. Second, we performed a survey on the characteristics of the CUE process including 25 centers. Third, we performed an intervention study, in which the CUE form originally applied in the study centre was compared with a newly developed CUE form in a before-after study design with respect to the corresponding CUE rates. RESULTS: (1) Clarity of the CUE forms varied considerably. (2) The CUE rate was higher (P < 0.05) when nurses rather than a physician were involved in informing the donors and when the CUE form was submitted anonymously instead of being handed to a person. (3) Application of the newly designed CUE form which was rated as being very clear resulted in a 31% decrease in the CUE rate. CONCLUSIONS: Design of the CUE form and characteristics of the CUE process may considerably influence the CUE rates.