Outcomes of Patients Who Undergo Transfusion of Fresh Frozen Plasma: A Prospective, Observational, Multicentre Cohort Study in Hiroshima, Japan.

PURPOSE: Given the chronic shortage of blood for transfusion in Japan, promotion of appropriate use of fresh frozen plasma (FFP) urgently needs to be addressed by the national blood project in Japan. Whether FFP transfusions are administered appropriately in Japan is currently unclear. In this study, we aimed to investigate the outcomes of patients who undergo FFP transfusion and the appropriateness of use of FFP. PATIENTS AND METHODS: This multicentre, prospective, observational cohort study was conducted from September 2017 to April 2019 at the 15 medical institutions in Hiroshima Prefecture that are the top providers of FFP. All patients who underwent FFP transfusion during the study period were included, relevant data being extracted from the medical records. The indications for FFP transfusion were classified in accordance with the Guidelines of the Ministry of Health, Labour and Welfare of Japan. Factors associated with patient outcomes at day 28 after FFP transfusion were subjected to multivariable logistic regression analysis. RESULTS: In total, data of 1299 patients were eligible for analysis. At least 63.8% of indications for FFP were in accordance with the guideline for FFP transfusions. The mortality rate at day 28 after FFP transfusion was 16.2%. Older age (65-74 years: adjusted odds ratio [AOR]=4.3, ≥75 years: AOR=4.1), non-perioperative use (AOR=4.5), coagulopathy associated with liver damage (AOR=2.7), large volume of FFP transfused (AOR=2.5), and lack of improvement in blood coagulation following FFP transfusion were independently and significantly associated with death within 28 days after FFP transfusion. CONCLUSION: Our findings do not support the simple conclusion that FFP transfusions contribute to prognosis. However, given that coagulopathy in patients with end-stage liver disease is infrequently improved by FFP transfusion, "inappropriate" use of FFP should be avoided. It is important to promote appropriate use of FFP so as not to waste blood resources.

Impact of the mobilization regimen and the harvesting technique on the granulocyte yield in healthy donors for granulocyte transfusion therapy.

BACKGROUND: Granulocyte mobilization and harvesting, the two major phases of granulocyte collection, have not been standardized. STUDY DESIGN AND METHODS: The data on 123 granulocyte collections were retrospectively investigated for the effect of the mobilization regimen and the harvesting technique. After a single subcutaneous dose (600 µg) of granulocyte-colony-stimulating factor (G-CSF) with (n = 68) or without (n = 40) 8 mg of orally administered dexamethasone, 108 granulocyte donors underwent granulocyte collections. Moreover, 15 peripheral blood stem cell (PBSC) donors who had received 400 µg/m2 or 10 µg/kg G-CSF for 5 days underwent granulocyte collections on the day after the last PBSC collections (PBSC-GTX donors). Granulocyte harvesting was performed by leukapheresis with (n = 108) or without (n = 15) using high-molecular-weight hydroxyethyl starch (HES). RESULTS: Granulocyte donors who received mobilization with G-CSF plus dexamethasone produced significantly higher granulocyte yields than those who received G-CSF alone (7.2 × 10(10) ± 2.0 × 10(10) vs. 5.7 × 10(10) ± 1.7 × 10(10) , p = 0.006). PBSC-GTX donors produced a remarkably high granulocyte yield (9.7 × 10(10) ± 2.3 × 10(10) ). The use of HES was associated with better granulocyte collection efficiency (42 ± 7.8% vs. 10 ± 9.1%, p < 0.0001). CONCLUSION: G-CSF plus dexamethasone produces higher granulocyte yields than G-CSF alone. Granulocyte collection from PBSC donors appears to be a rational strategy, since it produces high granulocyte yields when the related patients are at a high risk for infection and reduces difficulties in finding granulocyte donors. HES should be used in apheresis procedures.

Antigenicity and irritancy tests of leukocyte-reduction filters using animal models.

We experienced a patient who showed severe allergic symptoms immediately after blood transfusion using a filter for removal of leukocytes. To investigate the cause of this incident, we conducted a maximization test on the antigenicity of substances extracted from filters used for leukocyte removal. The tests were performed in guinea pigs. Acetone extracts were obtained from filters made by three manufacturers (A, B and C) and sensitization and evocation were tested at 10% concentration. It was confirmed that extracts from one filter (B) induced sensitization in guinea pigs. Sensitization of the extracts was also tested at 1%, 0.1% and 0.01%, and was induced at 1% but not at 0.1% and 0.01%. Next, skin irritation and sensitization of the substances were tested using mice. 5%-ethanol extracts were prepared from filters made by 2 manufacturers (A and B) and the extracts (5% or 0.5% concentrations) were injected intradermally into the auricle and the ear swelling was observed 1, 24 and 48 hours and 7 days after injection. Significant ear swelling was induced by the extracts from B-filters. In the skin sensitization test, 5% extracts were injected subcutaneously into the back of mice for 3 continuous days for sensitization, and 0.5% extracts were injected intradermally into the auricle of mice to evoke a response, after which changes in ear swelling were observed. Biphasic ear swelling observed 1 hour (immediate response) and 24 hours (delayed response) after challenge was induced by the extracts from B-filters. In conclusion, our study showed that filters used for leukocyte removal may contain substances that cause skin irritation and sensitization and that antigenicity and irritancy tests of the filters might prevent the adverse reactions after blood transfusion.