Crocco I, Franchini M, Garozzo G, Gandini AR, Gandini G, Bonomo P, Aprili G: Adverse reactions in blood and apheresis donors: experience from two Italian transfusion centres.Data Safety Data safety is performed according European, national, and state law.Thus complications related to haemapheresis procedures in Germany may add to several ten thousands adverse events (AEs) per year, even if they would occur in about 1-2% of the procedures only.
DEs comprise blood count abnormalities (e g. leucocytosis, low platelet counts) and donor compliance problems that might cause a break-off.No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.Fischer contributed equally to the development of the registry.The evaluation process takes place within approximately 60 s for the absolute AE numbers as well as for the relative AE numbers (percent calculations including the corresponding benchmark results that are given as percent values in brackets.Taken altogether, there were neither uniform study designs nor uniform definitions for AEs nor uniform definitions for the grading of the AEs so that a direct comparison of AE data between studies was impossible.
Please select Ok if you would like to proceed with this request anyway.Interestingly, CT-related AEs had the lowest relative break-off rate, indicating that this type of AE is easier to manage than other complications.Out of approximately 345,000 haemaphereses 16,477 AEs were reported (4.9%) from 20 participating centres.Please try to match the 2 words shown in the window, or try the audio version.Danic B, Lefort C: Serious adverse effects of blood collection (in French).Break-off 45 min after the start of the apheresis due to a mild, but therapy-refractory VVR. b Assessment of technical events.The conversion of height (cm) to height (inch), of body weight (kg) to body weight (lbs) and the calculations for total donor blood volume (TBV) and donor body mass index (BMI) are automatically carried out by the system.In severe reactions the user who finalizes the AE has to state the imputability of the AE to the apheresis procedure.
Automated Evaluation of AEs The centre administrator is qualified to start the evaluation programme for his specific centre.The design of the evaluation follows the sequence and order of the AE as enlisted in the IHN standard 2014.Theoretically, on-line registries like ours have the potential to overcome the variety of haemovigilance studies (as shown in table 1 ) with their widely incongruent and conflicting results.Introduction Modern haemapheresis machines enable transfusion medicine specialists to rapidly provide a wide variety of different blood components for therapeutic use.Internet-Based Haemapheresis Vigilance System General Characteristics The main purpose of this paper is the illustration of our method to assess and evaluate donor AEs in haemaphereses.McLeod BC, Price TH, Owen H, Ciavarella D, Sniecinski I, Randels MJ, Smith JW: Frequency of immediate adverse effects associated with apheresis donation.The evaluation tool has adopted the IHN standard, includes a benchmark function for comparison of AE data within the system and offers additional features such as break-off evaluation.
Here again the latest version of the IHN standard was followed.The majority of AEs occurred in PLSs (63%), followed by PLT (34.5%) and SC (2.2%). Blood access injuries (BAI) accounted for about 55% of the supplied AEs, whereas citrate toxicity symptoms, vasovagal reactions and technical events (e.g. disposable leakages, software failures) rather equally affected haemaphereses at 8-15%.After appropriate registration the on-line access allows every centre active in preparative aphereses from everywhere in the world to enter data into our system and to benefit from an automated evaluation according to internationally accepted standards.The patient received G-CSF plus plerixafor as mobilization regimen.Taken these considerations in mind and given that haemapheresis is a versatile field with different types of apheresis machines and many different technical procedures, it is not surprising that the results obtained from AE studies showed a wide variance.A further strength of the system is the possibility to exactly assess whether an apheresis procedure had to be prematurely terminated (fig. 3, table 4 ).
The latter ones are usually not part of donor haemovigilance systems but are also important to assess.Donor Safety in Haemapheresis: Development of an Internet-Based Registry for Comprehensive Assessment of Adverse Events from Healthy Donors. (LOC) on-side the.The AEs are evaluated for each type of apheresis procedure separately (e. g. PLT or PLS or SC apheresis etc.). Evaluations are possible for a time span ranging from 1 month to 1 calendar year.A skilful use of this feature reduces the number of operator-associated mandatory data entries from 15-20 per apheresis type to just two positions: the lot numbers for the apheresis tubing set and for the ACD-A solution.
Stadt Norderstedt / Neu in der Stadt
Tomita T, Takayanagi M, Kiwada K, Mieda A, Takahashi C, Hata T: Vasovagal reactions in apheresis donors.The AE results emerge either as absolute numbers or as relative numbers (percent values).Furthermore, in addition to the now available IHNstandard evaluation, other automated evaluation modes are being developed.
The study was approved by the Ethics Committee and by the Data Protection Commissioner of Hanover Medical School.Results: A preliminary evaluation encompassed the time period from January, 2012 to December, 2015.Finalized data only are included into the automated evaluation programme.Working Group on Donor Vigilance: Standard for Surveillance of Complications Related to Blood Donation.Please choose whether or not you want other users to be able to see on your profile that this library is a favorite of yours.Further developments may include the creation of interfaces to automate the import of, e.g., donor data or apheresis specifications and to establish data transfer to regulatory authorities in case of SAEs.
If one of these electronic index cards is activated by a click into the corresponding square click box, a tripartite submenu opens with the structure: symptoms typically associated with the AE that entitled the index card, possible interventions of the apheresis operator or donor physician to treat the AE and a free-text area for a brief comment to the AE (optional).The system secures that each centre has access to own data, but not to data of other centres.
The E-mail Address(es) you entered is(are) not in a valid format.Keywords: Adverse reactions Haemapheresis Haemovigilance Plasmapheresis Plateletpheresis Stem cell collection Donor safety Adverse events.Get this from a library! Fachserie / 12, Gesundheitswesen Reihe 2, Meldepflichtige Krankheiten. [Deutschland (Bundesrepublik). Statistisches Bundesamt.].Donor data are restricted to a minimum including the specific donation number, a pseudonymised donor-ID (optional), gender, year of birth, height, body weight and donor type (e. g., first-time or repeat apheresis donor, see fig. 2 a). No other donor data have to be given.Yuan S, Ziman A, Smeltzer B, Lu Q, Goldfinger D: Moderate and severe adverse events associated with apheresis donations: incidences and risk factors.For example, haematoma are not only a question of donor safety but may also trigger a training course for single staff members or for the whole operator group. - Third, to numeralize potential economic losses that are associated with premature break-offs of haemaphereses.
This is shown by the arrangement of the symptoms shown on the upper part the evaluation HTML page (fig. 5 ). The symptoms strictly follow the nomenclature and the order of the IHN standard 2014.Operators who carry out the haemaphereses usually enter AE data into the haemapheresis vigilance system.Thus our on-line system provides assessment and evaluation tools to support apheresis units in the versatile and complex field of haemapheresis.As some participating centres needed the first months in 2012 to start data assessment, the study will be presumably closed by June 30, 2019.The research or project support for this multi-centre trial was as follows: The study is, at least in part, financed by grants from the German Society for Transfusion Medicine and Immunohaematology (DGTI) and the Swiss Red Cross (SRC).