The evaluation of modified cell infusion method to reduce febrile non?hemolytic transfusion reaction in CD19 chimeric antigen receptor T cell threapy / 中华内科杂志

To retrospectively analyze the efficacy and safety of modified cell infusion method in reducing the incidence of febrile non?hemolytic transfusion reaction (FNHTR). Methods A total of 69 patients were enrolled in the clinical trial of CD19 chimeric antigen receptor T (CAR?T) cell treatment from February 2017 to October 2018. Study group received the modified cell infusion method, that 1×106 CAR?T cells were re?suspended in 2 mg human serum albumin with total volume of 20 ml and injected intravenously. The control group was intravenously administrated with CAR?T cell in 100 ml normal saline. The incidence of FNHTR, cytokine releasing syndrome (CRS) grade, cytokine level and efficacy were compared. Results (1)The incidence of FNHTR in the study group was 21.1%, significantly lower than that in the control group (71%)(P=0.000). (2)There was no statistical difference in cell proliferation between the study group and the control group on day 4, 7, 14 and 21 after CAR?T cell infusion (P=10.223, 3.254, 5.551, 7.605). (3)There was no statistical difference in CRS grading between the study group and the control group (P=0.767). There was no statistical difference in the levels of interleukin 2 receptor (IL?2R), IL?6, tumor necrosis factor (TNF)?α between the two groups. (4)The C?reaction protein (CRP) level of the study group was lower than that of the control group on day 4 and 7 (P=0.026, 0.007). (5)There was no statistical difference of response rates in acute lymphocytic leukemia (ALL) and non?Hodgkin lymphoma (NHL) patients between the two groups (PALL=0.842; PNHL=0.866). Conclusion The modified cell infusion method in CD19 CAR?T cell treatment reduces the incidence of treatment?related FNHTR. It does not affect the proliferation of CAR?T cells in vivo, the grading of CRS and the response rates.

The evaluation of modified cell infusion method to reduce febrile non-hemolytic transfusion reaction in CD19 chimeric antigen receptor T cell threapy / 中华内科杂志

Objective@#To retrospectively analyze the efficacy and safety of modified cell infusion method in reducing the incidence of febrile non-hemolytic transfusion reaction (FNHTR).@*Methods@#A total of 69 patients were enrolled in the clinical trial of CD19 chimeric antigen receptor T (CAR-T) cell treatment from February 2017 to October 2018. Study group received the modified cell infusion method, that 1×106 CAR-T cells were re-suspended in 2 mg human serum albumin with total volume of 20 ml and injected intravenously. The control group was intravenously administrated with CAR-T cell in 100 ml normal saline. The incidence of FNHTR, cytokine releasing syndrome (CRS) grade, cytokine level and efficacy were compared.@*Results@#(1)The incidence of FNHTR in the study group was 21.1%, significantly lower than that in the control group (71%)(P=0.000). (2)There was no statistical difference in cell proliferation between the study group and the control group on day 4, 7, 14 and 21 after CAR-T cell infusion (P=10.223, 3.254, 5.551, 7.605). (3)There was no statistical difference in CRS grading between the study group and the control group (P=0.767). There was no statistical difference in the levels of interleukin 2 receptor (IL-2R), IL-6, tumor necrosis factor (TNF)-α between the two groups. (4)The C-reaction protein (CRP) level of the study group was lower than that of the control group on day 4 and 7 (P=0.026, 0.007). (5)There was no statistical difference of response rates in acute lymphocytic leukemia (ALL) and non-Hodgkin lymphoma (NHL) patients between the two groups (PALL=0.842; PNHL=0.866).@*Conclusion@#The modified cell infusion method in CD19 CAR-T cell treatment reduces the incidence of treatment-related FNHTR. It does not affect the proliferation of CAR-T cells in vivo, the grading of CRS and the response rates.

Incidence of Adverse Transfusion Reactions from an Institutional Hemovigilance System: A Single Center Study / 대한수혈학회지

BACKGROUND: A hemovigilance system is essential to detect and analyze adverse transfusion reactions to various blood components. A blood bank physician has the role of discriminating the adverse transfusion reactions based on the hemovigilance criteria. This study investigated the incidence of adverse transfusion reactions per transfused case and the incidence of adverse transfusion reactions according to the various blood components in recipients. METHODS: From January 2016 to February 2017, 38,689 blood component units were transfused into 3,768 patients. A total of 11,170 transfused cases were reported. The patients’ signs or symptoms were monitored and reported by nurses using an electronic reporting system. A blood bank physician classified the adverse transfusion reactions according to the Korean hemovigilance reporting definitions. RESULTS: The frequency of all transfusion-related events was 469 according to the nursing record. Out of 469 events, 175 (37.3%) were classified as adverse transfusion reactions. The incidence of a febrile nonhemolytic transfusion reaction according to the blood component was highest for red blood cells (1.3%), followed by a platelets (0.8%) and fresh frozen plasma (0.3%). The incidence of allergic reactions was 1.0% (platelets), 0.8% (fresh frozen plasma), and 0.3% (red blood cells). The incidence of febrile nonhemolytic transfusion reactions was lowered significantly by leukocyte-reduction. CONCLUSION: The incidence of adverse transfusion reactions was 37.3% of the transfusion-related events. Therefore, close monitoring by the blood bank physician is essential for safe transfusion. The use of leukocyte-reduced blood components could reduce the incidence of febrile nonhemolytic transfusion reactions.

Frequency and Pattern of Noninfectious Adverse Transfusion Reactions at a Tertiary Care Hospital in Korea

BACKGROUND: Although transfusion is a paramount life-saving therapy, there are multiple potential significant risks. Therefore, all adverse transfusion reaction (ATR) episodes require close monitoring. Using the computerized reporting system, we assessed the frequency and pattern of non-infectious ATRs. METHODS: We analyzed two-year transfusion data from electronic medical records retrospectively. From March 2013 to February 2015, 364,569 units of blood were transfused. Of them, 334,582 (91.8%) records were identified from electronic nursing records. For the confirmation of ATRs by blood bank physicians, patients' electronic medical records were further evaluated. RESULTS: According to the nursing records, the frequency of all possible transfusion-related events was 3.1%. After the blood bank physicians' review, the frequency was found to be 1.2%. The overall frequency of febrile non-hemolytic transfusion reactions (FNHTRs) to red blood cells (RBCs), platelet (PLT) components, and fresh frozen plasmas (FFPs) were 0.9%, 0.3%, and 0.2%, respectively, and allergic reactions represented 0.3% (RBCs), 0.9% (PLTs), and 0.9% (FFPs), respectively. The pre-storage leukocyte reduction significantly decreased the frequency of FNHTRs during the transfusion of RBCs (P<0.01) or PLTs (Pfalling dots0.01). CONCLUSIONS: The frequency of FNHTRs, allergic reactions, and "no reactions" were 22.0%, 17.0%, and 60.7%, respectively. Leukocyte-reduction was associated with a lower rate of FNHTRs, but not with that of allergic reactions. The development of an effective electronic reporting system of ATRs is important in quantifying transfusion-related adverse events. This type of reporting system can also accurately identify the underlying problems and risk factors to further the quality of transfusion care for patients.

Universal Leukoreduction Decreases the Incidence of Febrile Nonhemolytic Transfusion Reactions to Cellular Blood Components: A 5 Year Study.

Background: Febrile nonhemolytic transfusion reactions (FNHTRs) are common complications associated with allogenic transfusion and it is caused by the leucocytes and cytokines released by leucocytes during storage of blood/ blood components. These reactions are generally not life threatening, but they are expensive in their management, evaluation, and associated blood-product wastage. 1st log prestorage universal leukoreduction (ULR) i.e. removal of Buffy coat is a useful and effective procedure in developing countries to control FNHTRs significantly. Aims and Objects: To know the efficacy of pre-storage 1st log universal leuckoreduction in controlling febrile nonhemolytic transfusion reactions (FNHTRs). Place and Duration of Study: Study was carried out at Blood Bank, Department of Pathology, G. R. Medical College, Gwalior from January 2009 to December 2013 (5years). Materials and Methods: Study was divided into control group (Year: 2009) and study group (Years: 2010-13). 14,292 recipients in control group and 45,064 in study group were transfused with non-leukoreduced and prestorage 1st log leukoreduced blood/ blood components respectively. Usefulness of prestorage 1st log ULR over non-leukoreduced blood/ blood components was observed, compared and discussed. Result: In the control group 610 (4.26%) out of 14,292 (p=0.0003) and in study group 381(0.84%) out of 45,064 (p=0.0003) recipients were reported to have FNHTRs. The comparative study showed significant reduction in FNHTRs from 4.26% to 0.84% (↓ 3.42%) (p=0.000001). Conclusion: 1st log Universal Leukoreduction (ULR) is a better option over Selective Leukoreduction (SLR) to prevent FNHTRs and it also helps the transfusion services of under-resourced developing countries in many ways.

Transfusion Premedication: A Single Center Study / 대한수혈학회지

BACKGROUND: Acute transfusion reaction occurs during or within a few hours of transfusion with 0.5~3% of blood transfusion. Febrile non-hemolytic transfusion reactions (FNHTRs) and allergic transfusion reactions (ATRs) are the most common transfusion reactions. Premedication with acetaminophen and diphenhydramine has been used to prevent these reactions in 50~80% of transfusions. The purpose of this study was to describe the frequency of premedication and FNHTRs and ATRs according to premedication in Korea. METHODS: Between January 1 and 31, 2013, analysis of the first transfusion was performed retrospectively with chart review. A total of 549 cases were analyzed with regard to product of blood, care area, premedication, and FNHTRs and ATRs. RESULTS: Premedication was administered in 88.2% (484/549) of transfusions; 4 mg chlorphenamine, a well-known antihistamine, was used as premedication in all cases. Occurrence of FNHTRs was 7.7% without premedication and 3.7% with premedication. Occurrence of ATRs was 0% without premedication and 0.8% with premedication. The frequency of premedication was related to care area but not blood products. CONCLUSION: Premedication use was more frequent than previously reported. However, the sample size in this study is small; therefore, conduct of further prospective multicenter studies is needed.

Changes of inflammatory cytokines in leukocyte-depleted PCs and decreased FNHTR by leukoreduced PCs transfusion / 中国输血杂志

Objective To investigate the changes of leukocyte derived cytokines,IL 1?,IL 6,IL 8,and TNF ?,in platelets concentrates (PCs) during storage,and to study the effect of leukodepletion on cytokine concentration in PCs and the incidence rate of febrile non hemolytic transfusion reaction (FNHTR).Methods 8 bags of apheresed PCs from 8 voluntary donors were each divided into two identical portions (A and B).Group A underwent leukocyte filtration,while group B did not.Then both groups were stored at 22℃ for 5 days.The levels of cytokines (pg/ml),white blood cell (WBC) count and platelet count in both groups were tested on the day 0,3 and 5 during storage.In clinic,240 patients were randomly divided into two groups with 120 in each group to receive non filtered or filtered PCs (1 bag/patient).The incidence of FNHTR was investigated.Paired t test and ? 2 test were used in data analysis. Results There was a significant positive correlation between the content of WBC in PCs and the level of cytokines.On the 5th day of storage,residual WBC in leukoreduced PCs were less than 1?10 6/PC,the levels of cytokines remained the same as those on 0;however,WBC in non filtered PCs was (351?81)?10 6/PC,and the levels of IL 1??IL 6?IL 8 and TNF ? were 105.0pg/ml,269.0pg/ml,1840pg/ml and 42.0pg/ml respectively and increased 18 ( P