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Donor data and apheresis specification HTML page: overview, displaying data entry possibilities for donor and apheresis variables (here: a double PLT/PLS multicomponent procedure).
Source publication
Background:
Currently, there is an extensive but highly inconsistent body of literature regarding donor adverse events (AEs) in haemapheresis. As the reports diverge with respect to types and grading of AEs, apheresis procedures and machines, the range of haemapheresis-related AEs varies widely from about 0.03% to 6.6%.
Methods:
The German Socie...
Contexts in source publication
Context 1
... an appropriate password-controlled login, the user is guided to the HTML pages 'Donor data and apheresis specification' ( fig. 1, 2) and 'Complication data' (fig. 3). The first page ( fig. 1, overview) consists of an upper part that records donor variables. 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 ...
Context 2
... an appropriate password-controlled login, the user is guided to the HTML pages 'Donor data and apheresis specification' ( fig. 1, 2) and 'Complication data' (fig. 3). The first page ( fig. 1, overview) consists of an upper part that records donor variables. 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. 2a). No other donor data have to be given. The ...
Context 3
... the system. To facilitate data input, the donation number and the donor-ID code can be entered by scanning barcodes. The middle and the lower part of the HTML page contain the specifications of the intended apheresis procedure that is involved in the AE. All types of preparative haemaphereses are available in form of electronic index cards: PLT ( fig. 1), PLS (fig. 2a), SC (fig. 2b), haemaphereses for PMN, MNC and RA (not shown). If one of these electronic index cards is activated by a click into the corresponding round button, the card opens with all information to the planned apheresis procedure that may be relevant for an AE: e.g., single/double needle plateletpheresis procedures, volume replacement, CT ...
Context 4
... round button, the card opens with all information to the planned apheresis procedure that may be relevant for an AE: e.g., single/double needle plateletpheresis procedures, volume replacement, CT prophylaxis and the number of target products (single-double-triple platelet units for transfusion) if they shall be routinely obtained in a PLT ( fig. 1), or the intended plasma yield of 650-850 ml in a PLS ( fig. 2a). Combinations of by-products can also be entered with a selection of plasma, of red cells or of plasma plus red cells, if they shall be obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis ...
Context 5
... platelet units for transfusion) if they shall be routinely obtained in a PLT ( fig. 1), or the intended plasma yield of 650-850 ml in a PLS ( fig. 2a). Combinations of by-products can also be entered with a selection of plasma, of red cells or of plasma plus red cells, if they shall be obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis device including machine and software identification, the lot numbers of the machine disposables (tubing sets and citrate/saline fluidities) and other specific variables such as the use of additive solution in PLT ( fig. 1). The system is also able to include complex ...
Context 6
... obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis device including machine and software identification, the lot numbers of the machine disposables (tubing sets and citrate/saline fluidities) and other specific variables such as the use of additive solution in PLT ( fig. 1). The system is also able to include complex haemaphereses such as blood stem cell procedures ( fig. 2b). This index card provides input positions that are unique for this type of apheresis: e.g., details to the donor (autologous or allogeneic), to the mobilization of the donor (G-CSF ± plerixafor), to priming procedures with red cells ...
Context 7
... shown in figure 1, many variables characterise apheresis procedures that are routinely done in a specific apheresis centre. For instance, a routine PLT may comprehend 16-18 positions for data entry ( fig. 1) because each variable may influence the type, the frequency and/or the severity of AEs. The specifications of other haemaphereses exhibit a similar extent (PLS, fig. 2a) or are even more complex (SC, fig. 2b). To simplify and accelerate the data entry for apheresis procedures, the centre administrator is enabled to generate electronic ...
Context 8
... assessment of these complications in the versatile field of preparative haemapheresis. The system is able to display virtually every routine apheresis procedure regardless which apheresis machine is used, which type of cells is collected or which combination of products (cellular products or plasma plus cellular blood components) are obtained ( fig. 1, 2). With respect to complication data, our system is able to assess all possible AEs in a way that the IHN Standard for Surveillance of Complications Related to Blood Donation is followed. As shown in figure 3, we have recently revised our system so that the 2nd edition of the IHN standard (effective from December 2014) with, e.g., rare ...
Context 9
... an appropriate password-controlled login, the user is guided to the HTML pages 'Donor data and apheresis specification' ( fig. 1, 2) and 'Complication data' (fig. 3). The first page ( fig. 1, overview) consists of an upper part that records donor variables. 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 ...
Context 10
... an appropriate password-controlled login, the user is guided to the HTML pages 'Donor data and apheresis specification' ( fig. 1, 2) and 'Complication data' (fig. 3). The first page ( fig. 1, overview) consists of an upper part that records donor variables. 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. 2a). No other donor data have to be given. The ...
Context 11
... the system. To facilitate data input, the donation number and the donor-ID code can be entered by scanning barcodes. The middle and the lower part of the HTML page contain the specifications of the intended apheresis procedure that is involved in the AE. All types of preparative haemaphereses are available in form of electronic index cards: PLT ( fig. 1), PLS (fig. 2a), SC (fig. 2b), haemaphereses for PMN, MNC and RA (not shown). If one of these electronic index cards is activated by a click into the corresponding round button, the card opens with all information to the planned apheresis procedure that may be relevant for an AE: e.g., single/double needle plateletpheresis procedures, volume replacement, CT ...
Context 12
... round button, the card opens with all information to the planned apheresis procedure that may be relevant for an AE: e.g., single/double needle plateletpheresis procedures, volume replacement, CT prophylaxis and the number of target products (single-double-triple platelet units for transfusion) if they shall be routinely obtained in a PLT ( fig. 1), or the intended plasma yield of 650-850 ml in a PLS ( fig. 2a). Combinations of by-products can also be entered with a selection of plasma, of red cells or of plasma plus red cells, if they shall be obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis ...
Context 13
... platelet units for transfusion) if they shall be routinely obtained in a PLT ( fig. 1), or the intended plasma yield of 650-850 ml in a PLS ( fig. 2a). Combinations of by-products can also be entered with a selection of plasma, of red cells or of plasma plus red cells, if they shall be obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis device including machine and software identification, the lot numbers of the machine disposables (tubing sets and citrate/saline fluidities) and other specific variables such as the use of additive solution in PLT ( fig. 1). The system is also able to include complex ...
Context 14
... obtained as a form a MC apheresis in single or double PLT ( fig. 1). Technical data entry comprehends information to the apheresis device including machine and software identification, the lot numbers of the machine disposables (tubing sets and citrate/saline fluidities) and other specific variables such as the use of additive solution in PLT ( fig. 1). The system is also able to include complex haemaphereses such as blood stem cell procedures ( fig. 2b). This index card provides input positions that are unique for this type of apheresis: e.g., details to the donor (autologous or allogeneic), to the mobilization of the donor (G-CSF ± plerixafor), to priming procedures with red cells ...
Context 15
... shown in figure 1, many variables characterise apheresis procedures that are routinely done in a specific apheresis centre. For instance, a routine PLT may comprehend 16-18 positions for data entry ( fig. 1) because each variable may influence the type, the frequency and/or the severity of AEs. The specifications of other haemaphereses exhibit a similar extent (PLS, fig. 2a) or are even more complex (SC, fig. 2b). To simplify and accelerate the data entry for apheresis procedures, the centre administrator is enabled to generate electronic ...
Context 16
... assessment of these complications in the versatile field of preparative haemapheresis. The system is able to display virtually every routine apheresis procedure regardless which apheresis machine is used, which type of cells is collected or which combination of products (cellular products or plasma plus cellular blood components) are obtained ( fig. 1, 2). With respect to complication data, our system is able to assess all possible AEs in a way that the IHN Standard for Surveillance of Complications Related to Blood Donation is followed. As shown in figure 3, we have recently revised our system so that the 2nd edition of the IHN standard (effective from December 2014) with, e.g., rare ...
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Background The plateletpheresis process is a great
improvement in transfusion medicine, and it is thought to be
generally safe to the donor. However, donors’ safety issues
and the anticoagulant used during these procedures have not
been fully explored. This study aimed at analyzing the
significance of alteration in some hematological parameters,
to...
Citations
... Generated using v.2.2.4 of EPPI-Mapper powered by EPPI Reviewer and created by the Digital Solution Foundry team. The 'Standard for Surveillance of Complications Related to Blood Donation' [4] was the most commonly used tool [34][35][36][37][38][39][40]. 7. or other factors (extracorporeal blood volume [41], geographical region of plasma collection [37] or donation with or without saline infusion [21]). ...
Background and objectives:
As part of a large-scale project to safely increase plasma collection in Europe, the current scoping review identifies the existing evidence (gaps) on adverse events (AEs) and other health effects in plasmapheresis donors, as well as factors that may be associated with such events/effects.
Materials and methods:
We searched six databases and three registries. Study characteristics (publication type, language, study design, population, outcomes, associated factors, time of assessment, duration of follow-up, number and frequency of donations, convalescent plasma [y/n], setting and location) were synthesized narratively and in an interactive evidence gap map (EGM).
Results:
Ninety-four research articles and five registrations were identified. Around 90% were observational studies (57 controlled and 33 uncontrolled), and most of them were performed in Europe (55%) or the United States (20%). Factors studied in association with donor health included donor characteristics (e.g., sex, age) (n = 27), cumulative number of donations (n = 21), donation frequency (n = 11), plasma collection device or programme (n = 11), donor status (first time vs. repeat) (n = 10), donation volume per session (n = 8), time in donation programme (n = 3), preventive measures (n = 2) or other (n = 9).
Conclusion:
The current scoping review provides an accessible tool for researchers and policymakers to identify the available evidence (gaps) concerning plasmapheresis donation safety. Controlled prospective studies with long-term donor follow-up are scarce. Furthermore, additional experimental studies comparing the health effects of different donation frequencies are required to inform a safe upper limit for donation frequency.
... Specially designed machine ensures the safety of the platelet donor during the procedure so that the procedure is well tolerated by the donor. Nevertheless, adverse events of variable severity may occur not only during but also after the plateletpheresis procedure 6,7 . An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure 8,9 . ...
Background/Aim. Plateletpheresis is a medical procedure used for the collection of donor platelets with multiple benefits for patients who will receive apheresis platelets. The procedure takes one hour and is well tolerated by donors. Nevertheless, adverse events may occur during and after the plateletpheresis procedure. The aim was to present one centre experiences in order to determine the incidence and type of adverse events associated with donor plateletpheresis. Methods. A retrospective analysis of adverse events associated with donor plateletpheresis was conducted in the Blood Transfusion Institute of Vojvodina over the period from January 1, 2010 through December 31, 2019. Results. Out of 2073 platelet donors 94.84% were multiple blood donors, predominantly male (98.55%). Adverse events were identified during 180 (8.68%) platelet donations with no statistical significance in occurrence in the first time (10.28%) and repeat donors (8.59%). Mild local reactions related to venous access (42.22%) were the most common adverse events. Generalized symptoms exhibited 16.67% of donors, 26.11% exhibited symptoms related to apheresis - citrate reactions and 15% exhibited those related to other complications. During plateletpheresis occurred 95.55% adverse events and 4.45% after. Conclusion. Donor plateletpheresis is a generally safe procedure, well tolerated by donors. Understanding risk factors for possible occurrence of adverse events provide support for adoption of measures to prevent them.
... It entails the same immediate risks as whole-blood donation with the additional unique apheresis-specific complications of risks for citrate toxicity, systemic allergic reaction, and air embolism [5]. The incidence of adverse donor reactions during platelet apheresis collection varies greatly, from 0.68% to 18% [6][7][8][9][10][11], depending on the skill of the collection staff, the characteristics of blood donors, the equipment employed, and the different classification schema and center-specific thresholds for identifying and reporting the reactions. Until now, few studies have specifically evaluated the characteristics and predictors of return platelet apheresis donation, including the influence of adverse reactions. ...
Introduction
Immediate adverse reactions experienced during donation decrease return rates among whole-blood donors, but little is known about this effect among platelet apheresis donors. We investigated the impact of immediate adverse reactions on the return rates of volunteer apheresis platelet donors.
Methods
In a sample of 4108 consecutive platelet apheresis donors seen from August 2016 through June 2019, we evaluated whether immediate adverse reactions were associated with returning for a subsequent platelet apheresis donation within a 12-month period. We used propensity score matching to compare donors with and without adverse reactions.
Results
An immediate adverse reaction occurred in 312 (7.6%) donors; 98.5% were mild, and 0.3% were severe. Of the original 4108 platelet apheresis donors, only 3211 (72.3%) returned for a subsequent donation within 12 months. Experiencing an immediate adverse reaction during the donation process significantly decreased the return rate for a subsequent donation [HR=0.74 (0.63-0.87)], especially among female donors [HR=0.70 (0.53-0.93)], donors aged <30 years [HR=0.71 (0.54-0.94)], with a high school educational level [0.63 (0.49-0.81)], donors donating for the first time [HR=0.73 (0.59-0.90)], and repeat donors with a previous platelet apheresis donation more than 180 days prior [HR=0.68 (0.50-0.93)].
Conclusion
Even mild adverse events reduce the return rates for a subsequent donation among platelet apheresis donors. Female donors, younger donors, and first-time donors are at higher risk of not returning after an immediate adverse reaction. Preventing the incidence of immediate adverse reactions during platelet apheresis donation may increase the rate of donor retention.
... 98 % der erfassten Reaktionen "mild", "klinisch insignifikant" oder "vernachlässigbar" sind? Die Antwort lautet: Ja, denn auch milde UE verursachen zu nahezu 80 % Verfahrensabbrüche [19]. ...
... Spendeverfahren [7, 12]. Die Spannweite zu den UE-Kategorien reichte von Punktionskomplikationen (PK) oder von vasovagalen Reaktionen (VVR) als Einzeluntersuchungsparameter [12, 14-16] über die Kombination von PK, Zitrattoxizität (ZT) und VVR in einer Vielzahl von Untersuchungen [5, 8, 10, 11, 13, 14, 17, 18] bis hin zu umfassenderen Studien, die PK, ZT, VVR, Spendercompliance und technisches Versagen von Apheresemaschinen oder deren Verbrauchsmaterial in ihre Untersuchung einbezogen [7, 8,19]. Angesichts der hier skizzierten Unterschiede im Design der vorliegenden Studien muss festgestellt werden, dass es zu keinem einzigen der genannten UE eine einheitliche wissenschaftliche Datenlage gibt. ...
... Die Frequenz von UE bei präparativen Hämapheresen kann 5 % erreichen oder überschreiten, wenn alle Kategorien von UE und alle Schweregrade in die Erfassung einbezogen werden.PK betreffen grundsätzlich alle Spendetechniken. Sie sind jedoch im Bereich der Hämapherese besonders schmerzlich, da sie in nahezu 80 % der Fälle zu Verfahrensabbrüchen führen[19]. Hämatome werden mit einer Frequenz von ca. ...
Zusammenfassung
Präparative Hämapheresen sind in vielen transfusionsmedizinischen Einrichtungen Standardverfahren zur modernen Herstellung von Blutprodukten. Sie kommen jährlich weltweit millionenfach zum Einsatz. Spenderreaktionen im Rahmen von präparativen Hämapheresen bei gesunden unverwandten Spendern sind dank moderner Apheresetechnik und hohen Prozessstandards heute ganz überwiegend als mild und klinisch nicht signifikant einzustufen. Die Kenntnis dieser, aber auch der seltenen schwerwiegenden Reaktionen, ihrer Symptome und ihrer Behandlung ist wichtig, um Spendersicherheit und Spendercompliance zu gewährleisten und Verfahrensabbrüche zu reduzieren bzw. zu vermeiden.
... Considering all types of apheresis procedures, plateletpheresis is the second cause of donors' adverse reactions, behind only plasmapheresis [18]. Possible adverse reactions include blood access injuries, vasovagal symptoms and alkalosis caused by citrate overload [18]. ...
... Considering all types of apheresis procedures, plateletpheresis is the second cause of donors' adverse reactions, behind only plasmapheresis [18]. Possible adverse reactions include blood access injuries, vasovagal symptoms and alkalosis caused by citrate overload [18]. In the present study, no SCT donor presented any adverse reaction to the apheresis procedure. ...
... What emanates from this first coarse assessment is that, rather than providing guidance for what to expect during leukapheresis, the referenced work illustrates the degree to which safety perception and adverse event documentation/grading differ from center to center. It is expected that the prospective donor vigilance initiatives of the large professional societies [17][18][19][20][21][22] will help clear up the picture. In the following, we will go through expected adverse reactions of leukapheresis, incorporating our experience with other forms of preparative apheresis. ...
Leukapheresis is like any other preparative apheresis, except it isn't: Leukapheresis typically takes much longer, larger blood volumes are processed and, consequently, larger ACD-A volumes are administered. Blood component donors and leukapheresis subjects are also quite different populations. Allogeneic donors tend to be younger and many are first-time donors, both of which are risk factors for adverse reactions during blood donation. Moreover, more than half of all leukapheresis collections are performed in patients. Here it is the age distribution, including patients at the extremes of age, as well as the underlying disease and co-morbidities which may expose them to higher, or different, risks compared to donors. Both groups thus have good reasons why adverse effects to leukapheresis might be more frequent, more severe, or even different in nature altogether. Compared to other preparative apheresis types like platelet or plasma apheresis, the risks of leukapheresis have been studied less extensively, as it is in comparison a relatively low-frequency intervention. Often leukapheresis remains a domain of hematologists who have a different sense of procedural safety than transfusionists. Furthermore, G-CSF mobilized "stem cell" aphereses by a wide margin outnumber unmobilized aphereses, so that the very strong signal from adverse reactions to G-CSF all but drowns out signals from the apheresis proper. This focused review assesses observations from leukapheresis as well as extrapolation of observations from other forms of preparative apheresis in an attempt to gauge the safety of leukapheresis and identify potential approaches to its further improvement. In short, the overall impression is one of a very satisfactory safety record of leukapheresis, with occasional issues with venous access or vasovagal problems, and frequent, but highly responsive and rarely limiting ACD-A toxicity.
The AUSL-IRCCS of Reggio Emilia Transfusion Unit operates in two blood donor centers. Plasmapheresis protocols and machines are identical in both centers, except for the final unit weight setting: 700 g in Center 1 and 720 g in Center 2. Within a wider study to assess the anticoagulant content in plasma units through proton nuclear magnetic resonance, we compared the efficiency of the two settings. We analyzed 215 and 100 consecutive samples from Centers 1 and 2, respectively. We collected processed blood volume, net plasma collected and anticoagulant volume in the plasma units. In our experience, setting the machine at 720 g instead of 700 g was associated with a small increase in plasma content of the final unit (only 4 mL), but implied an increase of more than 100 mL of the total processed blood and a higher amount of anticoagulant in the unit. On the contrary, the difference in donor's reinfused anticoagulant was negligible.
Our findings come from an observational study suggesting that, in view of a minimal advantage in terms of collected net plasma, there might be relevant disadvantages for the donor in prolonging plasmapheresis over 700 g. Since observed differences may be attributed to confounding factors, we recommend always checking the marginal efficiency of the procedure when the balance target value of the setting is increased. Randomized cross-over studies are needed to find the optimal target weight for plasma units. These studies could also help defining personalized plasmapheresis procedures, thus further optimizing donor safety.
