Most plasma used for manufacturing plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulin (Ig), and clotting factors is obtained from source plasma collected via plasmapheresis, the majority of which is contributed by the United States (US). While the demand for PDMPs continues to rise, it remains unclear whether high-frequency plasmapheresis, such as the twice-weekly plasma donation allowed in the US, may have any (long-term) adverse health effects on the donor. To investigate the frequency at which plasma can be donated without harm to the donor, the current systematic review explores the impact of plasma donation frequency on cardiovascular health, protein depletion, and adverse events in healthy plasma donors. We asked the following research question: What is the impact of plasmapheresis frequency (Intervention) on the safety or health (Outcome) of healthy donors (Population)? Six databases (PubMed, Embase, Web of Science, CINAHL, the Cochrane Library, and Transfusion Evidence Library), 2 clinical trial registries (ICTRP and clinicaltrials.gov), and the PROSPERO database were searched. Four observational and 2 experimental studies were included. The results showed that very high-frequency donation (twice per week) may result in a clinically relevant decrease in ferritin and bring IgG levels below the lower threshold of 6 g/l. However, the evidence is of low to very low certainty, and solid conclusions are hindered by the healthy donor effect and methodological limitations of the included studies. To determine a safe threshold donation frequency that minimizes any possible harmful effect on the donor, more high-quality prospective cohort studies and experimental studies are needed. We should expedite such studies to support recommendations, as conclusive evidence confirming or refuting the safety of maximum allowed donation frequencies is lacking. Donor protection is essential, given that healthy donors receive no direct medical benefit from donating plasma.

OBJECTIVE: Iron deficiency (ID) poses a prevalent concern among blood donors, especially impacting young donors, premenopausal females and frequent donors. In alignment with recommendations to address ID, routine ferritin testing was implemented in a hospital-based donor centre.
METHODS: Data set, encompassing 26 164 ferritin values from 16 464 blood donors over 33 months, were analysed retrospectively. Ferritin levels were assessed concerning donor characteristics such as sex, age, ethnicity and donation frequency.
RESULTS: Ferritin testing revealed age, sex and ethnicity variations, emphasising the heightened risk of ID in young females meeting all donation criteria under 23 year of age who demonstrated the lowest mean baseline ferritin (41% [CI: 34%-48%] < 26 ng/mL; 20% [CI: 14%-25%] < 15 ng/mL). Postmenopausal females exhibited ferritin levels similar to similarly aged males. Irrespective of sex, donors showcased mean ferritin recovery within 6 months. Analysis of ferritin recovery post-donation showed a five-fold increase in risk (compared with first visit) of ID when donors return at a 2-month interval. \'Regular\' donors (≥10 visits) approach a median steady ferritin level (~30-35 ng/mL) by the sixth visit.
CONCLUSIONS: As reliance on regular blood donors increases, donation policies must strike a balance between blood centre resources and the risks posed to both regular and at-risk donors. Frequent blood donation led to donors attaining a mean steady state ferritin level above the threshold for ID. At-risk groups, particularly premenopausal females, were several times more likely to experience ID after donation but demonstrated recovery rates similar to their group\'s baseline levels. This valuable information informed the development of new donor deferral policies.

Plateletpheresis has become a pivotal part of transfusion medicine. With the increasing demand for plateletpheresis, donor safety is an area of concern because plateletpheresis alters donor hematological parameters. For a better understanding of plateletpheresis, a systemic review is needed to study more evidence-based aspects of plateletpheresis. Electronic databases PubMed, Google Scholar, and Cochrane Library were used to find articles from January 1, 1980, to May 23, 2024. The random effect model was used to meta-analyze the effect of plateletpheresis on hematocrit, hemoglobin, and red blood cell (RBC) count. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed. A total of 24 studies were found; the effect of plateletpheresis on hemoglobin, hematocrit, and RBC count was studied in the following respective numbers of donors: 3,374, 3,374, and 690. A decrease of hemoglobin, hematocrit, and RBC count was observed after plateletpheresis having a weighted mean difference (WMD) of 0.50 (95%CI = -0.72 to -0.27), WMD of -1.36 (95%CI = -2.05 to -0.66), and WMD of -0.18 (95%CI = -0.23 to -0.12), respectively. Plateletpheresis shows a decrease in the value of hematological parameters such as hemoglobin, hematocrit, and erythrocyte count due to blood loss in the kits employed in the procedure; cell lysis was also seen because of exposure of erythrocytes to stress or change in osmotic pressure. Thus, strict criteria for donation must be developed for better safety of the donors. Improved automated cell separators for plateletpheresis should be made available in blood banks to ensure good quality hematologic products. Our findings suggest that the duration of the procedure should be decreased.

UNASSIGNED: There is no accepted way to define difficult donor hepatectomy (DiffDH) during open right live donor hepatectomy (ORLDH). There are also no studies exploring association between DiffDH and early donor outcomes or reliable pre-operative predictors of DiffDH.
UNASSIGNED: Consecutive ORLDH performed over 18 months at a single center were included. Intraoperative parameters were used to develop an objective definition of DiffDH. The impact of DiffDH on early postoperative outcomes and achievement of textbook outcome (TO) was evaluated. Donor morphometry data on axial and coronal sections of donor computed tomography (CT) at the level of portal bifurcation were collected. Donor and graft factors predictive of DiffDH were evaluated using univariate and multivariate logistic regression.
UNASSIGNED: One-hundred-eleven donors (male: 40.5%, age: 34 ± 9.5 years) underwent ORLDH during the study period. The difficulty score was constructed using five intraoperative parameters, i.e., operating time, transection time, estimated blood loss, need for intraoperative vasopressors, and need for Pringle maneuver. Donors were classified as DiffDH (score ≥ 2) or standard donor hepatectomy (StDH) (score <2). Twenty-nine donors (26%) were classified as DiffDH. DiffDH donors suffered greater all-cause morbidity (P = 0.004) but not major morbidity (Clavien-Dindo score >2; P = 0.651), more perioperative transfusion (P = 0.013), increased postoperative systemic inflammatory response syndrome (P = 0.034), delay in achieving full oral diet (P = 0.047), and a 70% reduced chance of achieving TO as compared to StDH (P = 0.007). On logistic regression analysis, increasing right lobe anteroposterior depth (RLdepth) was identified as an independent predictor of DiffDH (Odds ratio: 2.0 (95% confidence interval = 1.2, 3.3), P < 0.006). Receiver operating characteristic curve analysis identified an RLdepth of >14 cm as the best predictor of DiffDH (sensitivity:79%, specificity: 66%, area under curve = 0.803, P < 0.001).
UNASSIGNED: We report a novel definition of DiffDH and show that it is associated with worse postoperative outcomes, including a lesser chance of achieving TO. We also report that DiffDH can be predicted from readily available donor CT parameters.

Living liver donation (LLD) has been suggested as a potential solution to reduce the waitlist mortality for liver transplantation (LT) recipients by facilitating living donor liver transplantation (LDLT). Ensuring both donor and recipient safety is a critical aspect of LDLT. An accurate understanding of the complexity and extend of safety outcomes of the donor is imperative to maintain the high-quality standard this medical program requires. This review seeks to outline safety outcome parameters of interest for donors. Early postoperative mortality is very low with no significant differences comparing left lobe to right lobe LLD. Complications most commonly are biliary (leakage or strictures), bleeding, respiratory or pulmonary, gastrointestinal or infectious. Return to full-time work and quality of life are essential parameters in the mid and long term. As evidence continues to accumulate, outcomes may evolve with the expansion of minimal invasive surgery practice and currently laparoscopic approach is recommended in large experienced centers. By offering safer operations that require fewer incisions or liver resections, living liver donations can be further encouraged, and the perception of the procedure can be improved. Rational consideration of the safety of the donor and in-depth discussion and evaluation with the patient is of utmost importance.

BACKGROUND: Special Forces (SF) teams operate in remote environments with limited medical support. As a result, they may need to rely on buddy transfusions to treat bleeding teammates. Considering that 450 mL has no direct impact on their combat performances, it might be tempting to take more blood from a compatible donor to save a hemorrhaging teammate. This study investigates the effect of a 900 mL blood donation on SF operator performance and recovery time following this donation.
METHODS: Participants underwent a multifactorial assessment including measures of physiological parameters, vigilance, and physical performance. Results from the day of blood donation were compared with baseline values obtained 1 week earlier (i.e., immediate effect), as well as repeated testing at 7, 14, and approximately 30 days after blood donation (i.e., recovery period).
RESULTS: Hemoglobin levels and heart rate were affected by giving blood. The participants also experienced a significant decrease in physical performance of more than 50% immediately after blood donation. Recovery was slow over the following weeks, remaining significantly different from baseline until full recovery around day 30. However, participants were still able to respond to a simple stimulus and adjust their response, if necessary, even immediately after donating blood.
CONCLUSIONS: A 900 mL blood donation greatly affects the physical fitness of SF operators. A donation may be worthwhile if it is the only life-saving procedure available and does not endanger the donor\'s life. The donor would then become a patient and unable to complete the mission.

Aim To analyse changes in haematological values after plateletpheresis in donor population with regard to donor safety. Methods A retrospective study was conducted on first time and repeated healthy donors over a period of eight months in the Blood Transfusion Institute in the Federation of Bosnia and Herzegovina in Sarajevo. A total of 75 plateletpheresis procedures performed using Amicus continuous flow cell separator were evaluated. Various pre- and post-donation haematological values were measured in all donors: haemoglobin concentration (Hb), haematocrit (Hct), red blood cell count (RBC), platelet count (PLT), white blood cell count (WBC), mean platelet volume (MPV), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), and mean corpuscular haemoglobin concentration (MCHC). Results A significant decrease in post-donation Hb, Hct, RBC, PLT, MCHC (p<0.000) and WBC (p=0.003), and a significant increase in MPV (p=0.011) and MCV (p<0.000) was found. Percentage reduction of haematological parameters Hb, Hct, RBC, PLT, WBC and MCHC decrease of 6.6%, 6.5%, 5.9%, 24%, 4.6% and 0.3%, respectively, in their respective count was noted postdonation. Eight (11%) donors had a post-procedure platelet count less than 150x10e9/L. Twenty two donors (29%) experienced mild side effects due to hypocalcaemia. Conclusion Plateletpheresis procedures are generally safe and well tolerated, without evident associated clinical manifestations on healthy donors.

Living donor kidney transplantation (LDKTx) is recommended by all scientific societies. Living donor nephrectomy (LDN) is probably one of the safest surgical procedures, but it carries some risk for healthy donors. The aim of this study is to provide a snapshot of LDKTx activities in Italy and ask about safety measures implemented in LDN. Data on LDKTx were extracted from the national database. Safety measures were examined through a specific survey. Between 2001 and 2022 40,663 kidney transplants (31.4 per million population-pmp) were performed, including 4731 LDKTx (3.7 pmp). There was no postoperative death of the donor. After a median follow-up of 52.2 months [IQR:17.9-99.5], the 10-year donor survival rate was 93.38% (CI:97.52-98.94). There was evidence of renal disease in 65 donors (1.8%), including 42 (1.1%) with stage III end-stage renal disease. Twenty-nine out of 35 transplant centers (TC) involved in LDKTx responded to the survey (82.9%). Six TCs (21.4%) had a total experience of 20 or fewer LDN. Minimally invasive LDN was the first choice at 24 TC (82.8%). At 10 TC (37.0%) only one surgeon performed LDN. Nineteen TCs (65.5%) had a surgical safety checklist for LDN and 14 had a postoperative surveillance protocol. The renal artery was occluded in 3 TCs (10.3%) mainly by non-transfixion methods (including clips). Redundancy of key safety systems in the operating room was available in 22 of 29 centers (75.8%). In summary, LDKTx should be further implemented in Italy. Donor safety should be improved through the implementation of a national procedural protocol.

OBJECTIVE: Unusual grafts, including extended left liver plus caudate lobe, right anterior section, and right posterior section grafts, are alternatives to left and right lobe grafts for living-donor liver transplantation. This study aimed to investigate unusual grafts from the perspectives of recipients and donors.
METHODS: From 2016 to 2021, 497 patients received living-donor liver transplantation at Severance Hospital. Among them, 10 patients received unusual grafts. Three patients received extended left liver plus caudate lobe grafts, two patients received right anterior section grafts, and five patients received right posterior section grafts. Liver volumetrics and anatomy were analyzed for all recipients and donors. We collected data on laboratory examinations (alanine aminotransferase, total bilirubin, international normalized ratio), imaging studies, graft survival, and complications. A 1:2 ratio propensity-score matching method was used to reduce selection bias and balance variables between the unusual and conventional graft groups.
RESULTS: The median of Model for End-stage Liver Disease score of unusual graft recipients was 13.5 (interquartile range 11.5-19.3) and that of graft-recipient weight ratio was 0.767 (0.7-0.9). ABO incompatibility was observed in four cases. The alanine aminotransferase level, total bilirubin level, and international normalized ratio decreased in both recipients and donors. Unusual and conventional grafts had similar survival rates (p = 0.492). The right and left subgroups did not differ from each counter-conventional subgroup (p = 0.339 and p = 0.695, respectively). The incidence of major complications was not significantly different between unusual and conventional graft recipients (p = 0.513). Wound seromas were reported by unusual graft donors; the complication ratio was similar to that in conventional graft donors (p = 0.169).
CONCLUSIONS: Although unusual grafts require a complex indication, they may show feasible surgical outcomes for recipients with an acceptable donor complication.

Source plasma collections are needed to satisfy the growing demand for plasma-derived medicinal products. The US plasma collection target volume has been guided by a standard weight-based FDA-issued nomogram (STAN) since 1992. In this research, large-scale US-based real-world data (RWD) were analyzed to confirm the safety and volume gains of a newly introduced personalized nomogram (PERS) that was previously studied in a premarket randomized controlled environment.
A non-inferiority (NI) analysis was conducted to compare the novel nomogram\'s significant hypotensive adverse event (AE) incidence rate with large historical standard nomogram AE datasets. Additionally, the average target volumes and donor return rates were compared for collections following PERS and STAN.
A total of 4,816,784 donations (PERS) by 414,957 donors resulted in a rate of 0.0998% (95% CI [0.0970, 0.1027]) significant hypotensive AEs. NI analysis suggested strong non-inferiority of the new technology (Δ = -0.0082%, 95% CI [-0.0113, -0.0050], prespecified NI margin = 0.1080). Average plasma collection target volumes increased by 66.39 mL (8.49%; p < .0001). Consecutive weekly donor return rates were consistent between the two nomograms (PERS: 73.6%, 95% CI [69.6%-76.7%]; STAN: 74.1%, 95% CI [66.1%-77.2%]).
This analysis confirms in a large-scale real-world dataset the key safety parameter and collection benefit of a novel, technology-enabled nomogram. The nomogram may help meet the growing demand for plasma-derived therapies by providing approximately 8.5% more plasma per donation on average while maintaining donor safety and return rates.