Hemovigilance: is it making a difference to safety in the transfusion chain?

Hemovigilance is the systematic monitoring of adverse reactions and incidents in the transfusion chain in order to make recommendations for safety improvement. EU member states must have a reporting system for serious adverse reactions or events which might have an effect on quality or safety of blood components. The thesis presents an analysis of routinely collected data on occurrence of blood donation complications and risk factors. A study of procedural and follow-up data from a cohort of related peripheral blood stem cell donors gave no indication of unacceptable risks. In transfused patients an exploratory case-control study found previously undescribed associations with patient characteristics. Using national hemovigilance data the reduction of the risk of TRALI following implementation of male-only plasma was estimated as 33%. Hospitals with a relatively high rate of reported nonserious transfusion reactions were also more likely to have reported one or more transfusion errors, thus this does not support the notion that they might be safer. Hemovigilance reporting has provided insight in short-term risks in the transfusion chain. Additonal methods should be sought for monitoring long-term risks and for promoting measures to bring about safety improvement.Sanquin Blood Supply study grant PPOC 08-008 for study on G-CSF mobilised donors. Printing of this thesis was financially supported by Stichting TRIP (Transfusie- en transplantatiereacties in patiënten) Sanquin Blood Supply Haga Teaching HospitalUBL - phd migration 201

Guideline development for prevention of transfusion-associated graft-versus-host disease: reduction of indications for irradiated blood components after prestorage leukodepletion of blood components

Transfusion-associated graft-versus-host disease (TA-GVHD) is a rare, commonly fatal complication of transfusion preventable by irradiation of blood units. The revision of the Dutch transfusion guideline addressed the question whether irradiation is still necessary if blood components are prestorage leukodepleted. We searched for published cases of TA-GVHD following transfusion of prestorage leukodepleted blood and through contacting haemovigilance systems. Six presumed cases were found, dating from 1998 to 2013. Four out of six patients had received one or more non-irradiated units despite recognised indications for irradiated blood components. In the countries providing information, over 50 million prestorage leukodepleted, non-irradiated, non-pathogen-reduced cellular components were transfused in a 10-year period. Potential benefits of lifting indications for irradiation were considered. These include reduced irradiation costs (euro 1.5 million annually in the Netherlands) and less donor exposure for neonates. Findings were presented in an invitational expert meeting. Recommendations linked to human leukocyte antigen similarity between donor and recipient or intra-uterine transfusion were left unchanged. Indications linked to long-lasting deep T-cell suppression were defined with durations of 6 or 12 months after end of treatment (e.g. autologous or allogeneic stem cell transplantation). Need for continued alertness to TA-GVHD and haemovigilance reporting of erroneous non-irradiated transfusions was emphasised.Immunobiology of allogeneic stem cell transplantation and immunotherapy of hematological disease

Transition from fresh frozen plasma to solvent/detergent plasma in the Netherlands: comparing clinical use and transfusion reaction risks

Plasma transfusion is indicated for replenishment of coagulative pro- teins to stop or prevent bleeding. In 2014, the Netherlands switched from using similar to 300mL fresh frozen plasma (FFP) units to using 200mL Omniplasma, a solvent/detergent treated pooled plasma (SD plasma), units. We evaluated the effect of the introduction of SD plasma on clinical plasma use, associated bleeding, and transfusion reaction incidences. Using diagnostic data from six Dutch hospitals, national blood bank data, and national hemovigilance data for 2011 to 2017, we compared the plasma/red blood cell (RBC) units ratio (f) and the mean number of plasma and RBC units transfused for FFP (similar to 300mL) and SD plasma (200mL) for various patient groups, and calculated odds ratios comparing their associated transfusion reaction risks. Analyzing 13,910 transfusion episodes, the difference (Delta f = f(SD) (-) f(FFP)) in mean plasma/RBC ratio (f) was negligible (Delta f(entire-cohort) = 0.01 [95% confidence interval (CI): -0.02 - 0.05]; P=0.48). SD plasma was associated with fewer RBC units transfused per episode in gynecological (difference of mean number of units -1.66 [95% CI: -2.72, -0.61]) and aneurysm (-0.97 [-1.59, -0.35]) patients. SD plasma was further associated with fewer anaphylactic reactions than FFP (odds ratio 0.37 [0.18, 0.77; P<0.01]) while the differences for most transfusion reactions were not statistically significant. SD plasma units, despite being one third smaller in volume than FFP units, are not associated with a higher plasma/RBC ratio. SD plasma is associated with fewer anaphylactic reactions than FFP plasma/RBC units ratio.Clinical epidemiolog

Observational etiologic research Part 1-The etiologic research question: it requires DATA

Clinical epidemiolog

Presence of medication taken by blood donors in plasma for transfusion

Background and Objectives: The TRIP national hemovigilance and biovigilance office receives reports on side-effects and incidents associated with transfusion of labile blood products. Anaphylactic reactions accounted for the largest number of serious transfusion reactions in the period 2008-2012. In most cases, no cause is found for these reactions. TRIP data show that anaphylactic reactions occur relatively frequently with transfusion of plasma or platelet concentrates. Data from blood services show that 10% or more of plasma donors regularly use medication which is permitted under donation guidelines. It is conceivable that medication taken by the donor in plasma for transfusion could cause an anaphylactic transfusion reaction in the recipient. This exploratory study investigated the presence of drugs or drug metabolites in donor plasma. Materials and Methods: Samples (5 ml) were taken from thawed, quarantine fresh frozen plasma units (FFP) which had to be rejected for transfusion because of leaks or length of time after thawing. The samples were analysed for approximately 1000 drugs and drug metabolites using a toxicological screening method. Results: Eighty-seven samples were analysed. Toxicological screening was positive in fourteen samples (16%). In eleven samples, one substance was found, and in three samples, the presence of two or three drugs was detected. Conclusion: After freezing, storage and thawing of fresh FFP, it is possible to detect medication taken by the donor. Further investigation is recommended to analyse whether donors' medication in plasma can be implicated in some cases of allergic or anaphylactic reactions in transfusion recipients

Observational etiologic research Part 4-Matching in case-control studies: almost always a bad idea

Clinical epidemiolog

Observational etiologic research Part 3-Case-control studies: it's all about the source population

Clinical epidemiolog

Quality validation of data in national haemovigilance systems in Europe: report of a survey on current state of practice

Clinical epidemiolog