Medicine and Pharmacology

Abstract: Background: Psychosocial assessment is central to lung transplant evaluation. Structured tools such as the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) can be used either to support exclusionary decisions or to guide psychosocial prehabilitation by identifying modifiable targets for intervention. We examined how SIPAT functions in a program that explicitly prioritizes remediation of modifiable psychosocial risks. Methods: We conducted a retrospective observational cohort study of consecutive adult lung transplant candidates evaluated at a single center in Poland between December 2021 and November 2025. Psychosocial risk was assessed using SIPAT (locally translated), including total and domain scores, candidate categories, and binary indicators of clinically relevant alcohol, illicit substance and nicotine related risk. The primary endpoint was a pragmatic program outcome, defined as ever being listed (including transplanted) versus not listed. Analyses focused on describing psychosocial risk profiles and their relationship to the program pathway rather than on building a predictive model of listing decisions. Results: In 491 candidates (mean age 57.2 years; 40.5% women), psychosocial burden was generally low (mean total SIPAT 12.4, SD 6.8) and most patients were rated as excellent or good candidates. SIPAT total, domain scores and candidate categories were not meaningfully associated with ever being listed. Nicotine related risk was more frequent among listed candidates, consistent with a clinical strategy in which smoking histories in predominantly COPD and emphysema patients trigger intensive cessation support rather than automatic exclusion. Cluster analyses identified a smaller high-risk subgroup, and ROC analyses showed modest discrimination for alcohol and nicotine related risk, supporting SIPAT as a structured needs assessment. Conclusions: In this prehabilitation oriented program, SIPAT did not operate as a binary gatekeeping instrument for listing. Instead, it primarily served to identify modifiable psychosocial targets that trigger tailored support. These findings support using SIPAT as a structured roadmap for psychosocial prehabilitation rather than a stand-alone exclusion tool.

Abstract: Kidney transplantation for patients affected by end stage renal failure is considered the best therapeutic option, but this possibility is limited by deceased donor shortage. Living donor kidney transplantation (LDKD) is a valuable option, frequently limited by immunological incompatibility between donor and recipient. This review will consider the to date possibility of performing living donor kidney donation in the case of AB0 blood group incompatibility and the progresses that have been made in this field. Kidney paired donation is one possibility. Such technique offers the best possibility if the number of pairs available is wide. This is possible by performing national and also international registries. The technique more diffuse is the desensitization of the recipients. Desensitization may be obtained by several ways that are extensively treated in this review. In the recent period some published studies document the possibility to enzymatically convert A or B group from the cells of the donor to 0 group. This possibility is only on the beginning, but may represent the future eventually associated to a mild desensitization.

Abstract: Background: Transparent and complete reporting of clinical trial information across registries and peer-reviewed publications is essential for reliable interpretation of clinical evidence. Previous studies have demonstrated discrepancies between trial registries and journal publications, but data specifically focusing on transfusion medicine trials remain limited. Objectives: To assess reporting completeness and consistency for key WHO Trial Registration Data Set (WHO TRDS) items and safety outcomes across the trial life cycle in transfusion medicine-related clinical trials. Methods: We conducted an observational study of clinical trials in transfusion medicine with available results registered in ClinicalTrials.gov between January 2011 and May 2019. Reporting of WHO TRDS items was evaluated at three predefined time points: initial registry entry, final registry update, and corresponding peer-reviewed journal publication. Changes and missing items were systematically assessed, and adverse event and mortality reporting were compared between registry records and journal publications. Results: A total of 67 eligible clinical trials were identified, of which 45 had corresponding peer-reviewed journal publications. At initial registration, several TRDS items were frequently missing, particularly timeline and outcome-related fields. Completeness improved substantially in the final registry updates but was not consistently maintained in journal publications, where incomplete or discordant reporting was common for enrolment and completion dates, eligibility criteria, and outcome definitions. Differences between final registry records and publications were observed in the majority of trials. Safety reporting also differed between sources: serious adverse events were reported at similar overall frequencies, but were more detailed in registry entries, whereas deaths were more frequently reported in publications and explicit reporting of zero adverse events was more common in the registry. Conclusions: Clinical trials in transfusion medicine show inconsistencies between registry records and corresponding journal publications across key methodological and safety reporting domains. These differences may limit transparency, reproducibility, and the reliability of evidence synthesis. Closer alignment between trial registries and scientific publications is needed to strengthen the trustworthiness of clinical information in transfusion medicine.

Abstract: Background: Lung transplantation (LTx) remains the final therapeutic option for patients with end-stage and irreversible respiratory failure. The most common complication after LTx is chronic lung allograft dysfunction (CLAD), which affects long-term outcomes. However, CLAD may be partially reversible, especially after early detection of the cause. For this reason, systematic monitoring of transplanted lung function, including spirom-etry values, is so important. In these cases, the usage of modern technologies and tele-medicine can be extremely useful and allow for early response to possible decreases of spirometry values. Objective: The aim of our study is to evaluate the feasibility and clinical usefulness of spirometry telemonitoring in lung transplant patients. Methods: This retrospective study compared lung transplant recipients, where the first group of patients was subjected to spirometry telemonitoring (N=21), the second group was monitored with standard home spirometry (N=23), and the control group underwent routine follow-ups only in the transplant center (N=32). Results: The mean number of emergency visits was found to be lower in the telemoni-toring vs routine care group (1.24 vs 2.34, P=.05). Additionally, the mean duration of all visits was higher in the routine care group (10.0 days) in comparison to the telemonitoring group (5.8 days, P< .001) and to the standard home spirometry group (8.7 days, P=0.03). Conclusions: Spirometry telemonitoring using digital devices is not only feasible in lung transplant recipients, but it may provide substantial clinical benefits in this group of patients. It makes it possible to react faster in the event of abnormalities, which results in a reduction in the number of emergency visits and their duration.

Abstract: Cerebral toxoplasmosis is a rare but potentially fatal opportunistic infection in renal transplant recipients receiving long-term immunosuppressive therapy. It may result from donor-derived transmission or reactivation of latent infection. We report the case of a 70-year-old female who underwent cadaveric kidney transplantation in 2004 for end-stage renal disease due to glomerulonephritis. She was maintained on cyclosporine, mycophenolate mofetil, and prednisone. In September 2024, she presented with headache, mood changes, and right-sided hemiparesis. Brain multislice computed tomography revealed a large temporoparietal lesion initially suspected to be glioblastoma. Craniotomy and histopathological analysis demonstrated encysted Toxoplasma gondii bradyzoites within gliotic tissue. Polymerase chain reaction testing confirmed the presence of T. gondii DNA, while human immunodeficiency virus testing was negative. The patient reported frequent contact with domestic cats. Treatment with pyrimethamine, sulfadiazine, and leucovorin, alongside adjustment of immunosuppressive therapy, led to marked neurological improvement and radiological regression of the lesion. However, nine months later, she succumbed to multidrug-resistant urosepsis. This case highlights the diagnostic challenges of cerebral toxoplasmosis in transplant recipients, as radiological findings are often nonspecific and can mimic neoplastic or lymphoproliferative lesions. Polymerase chain reaction and histopathological analysis remain essential for definitive diagnosis. Awareness of this rare complication is critical for early recognition and prompt initiation of anti-toxoplasma therapy, which can significantly improve outcomes. Although cerebral toxoplasmosis is uncommon after kidney transplantation, it should be considered in immunosuppressed patients presenting with neurological symptoms. Early detection and targeted therapy are key to reducing morbidity and mortality in this population.

Abstract: Background and hypothesis: Because of the narrow therapeutic range and inter-individual differences in tacrolimus trough levels, the total daily dose and their ratio are commonly used to determine proper tacrolimus. In our study, the Life-Cycle Pharma-tacrolimus formulation was compared to Immediate-release Tacrolimus in a real-life setting. Methods: This longitudinal observational study included kidney transplant patients at two Hungarian university clinic’s study centers. Sixty-three (63) patients completed the study and were included in the statistical analysis. They received either Life-Cycle Pharma-tacrolimus (n=40) or Immediate-release Tacrolimus (n=23) maintenance therapy as the two study arms, all combined with everolimus or mycophenolic acid and corticosteroid. Patients were enrolled in the study 4-6 weeks after transplantation and were observed for 48 months. Tacrolimus trough level, total daily dose and their ratio were recorded at each of the seven follow-up visits, during the 48 months study period. Epidemiology data, patient characteristics, blood parameters (including eGFR, de novo DSA, CMV and BK virus incidence), and the acute rejection episodes were monitored. Results: Mean age at enrolment was 53.35 years, males n=41 (65.08%). A steady, therapeutic maintenance trough level was achieved in both study arms. Dosing of Life-Cycle Pharma-tacrolimus required a 30% lower total daily dose compared to Immediate-release Tacrolimus to achieve the therapeutic trough level. A slow deterioration of eGFR was observed (mean decrease of 6.06 mL/min/1.73m2 over 4 years) in the Immediate-release Tacrolimus arm in contrast to the Life-Cycle Pharma tacrolimus arm, where the eGFR increased (by 4.76 mL/min/1.73m2) in 4 years period. Conclusions: Both formulations were both proper long-term immunosuppressive treatments for kidney transplant patients, maintaining a stable trough level. Life-Cycle Pharma tacrolimus might serve as a valuable choice in avoiding drug-specific side effects, reducing calcineurin-induced nephrotoxicity.

Abstract: Chronic allograft dysfunction (CLAD) is the main cause of graft loss after lung transplantation (LTR). Within the immunological factors involved in CLAD development, the antibody-mediated rejection (ABMR) has the most impact. However, ABMR diagnosis is difficult due to the limited sensitivity of histopathological, immunhistochemical, and immunological criteria currently used. Growing evidence is demonstrating the impact of molecular mismatch in ABMR; here, we ought to assess the potential role of molecular mismatch in CLAD development. A total of 457 LTR were recruited for the study, with HLA type from donors and recipients to assess molecular mismatch, and with a minimum follow-up of 180 days. The combination of molecular mismatch in class-II (HLA-EMMA and HLA-Matchmaker algorithms) with EMMA DR score >12 and antibody verified eplet mismatch in DRB1345 (AbV DRB1345) > 3 predicts CLAD development independently of ex-smoker, prolonged period of hospitalization (>33 days), acute cellular rejection (ACR), and ABMR. The HR of the prediction model for molecular mismatch in class-II was 1.52 (1.01-2.56, p=0.045). This observation could point to a potential role of poor molecular mismatch in class-II to fill the gap of underdiagnosis of ABMR, previous to CLAD development. Prospective studies should be addressed to confirm the utility of molecular mismatch in the identification of patients at risk of CLAD development.

Abstract: The management of asymptomatic bacteriuria (ASB) and candiduria (ASC) in kidney transplant recipients during the early post-transplant period is controversial. This study aimed to evaluate whether treating, versus not treating, ASB and ASC episodes in the first two months after kidney transplantation influences clinical outcomes and the emergence of multidrug resistant (MDR) infections. We conducted a single-center retrospective cohort study enrolling patients with ASB or ASC occurring in two first two month after kidney transplantation between January 2019 and July 2024. Patients were classified into treated and untreated groups. The primary endpoint was 30-day mortality. Secondary endpoints included mortality at 90, 180 and 360 days; incidence of sepsis or septic shock; bacteremia/candidemia, hospi-talization, graft loss; decline in renal function, urinary tract infections (UTIs), recur-rent UTI and rate of MDR colonization/infection. We enrolled 59 kidney transplant recipients and observed 147 episodes of ASB/ASC. Of the 147 episodes, 95 were untreated and 52 were treated. No significant differences were observed between treated and untreated patients in 30-day (2.1% vs. 3.8%) or 90-day mortality (2.1% vs. 1.9%), nor in any of the secondary clinical outcomes. How-ever, patients who received treatment tended to have a higher rate of MDR coloniza-tion/infection (63% vs. 46%). MDR pathogen isolation was significantly associated with increased risks of septic shock (OR 4.639,p=0.04), bacteremia/candidemia (OR 3.734,p=0.01), hospitalization (OR 2.183,p=0.03), and renal function deterioration (OR 3.93,p=0.03). Antimicrobial treatment of ASB and ASC in the early post-transplant period would seem not to confer clinical benefit and may increase the risk of MDR coloniza-tion/infection.

Abstract: Kidney transplantation activity at the University Hospital of Guadeloupe was briefly interrupted at the onset of the COVID-19 pandemic. This study assessed patient and graft survival in 335 recipients transplanted between 2013 and 2023, comparing those transplanted before 2020 and after the resumption of activity. Most patients (70%) received transplants before 2020, with 30% after-ward. ABO compatibility was observed in 98.2% of grafts from brain-dead do-nors. Peak transplant activity occurred in 2018, followed by a decline until 2021 and recovery from 2022. After 2020, recipients were more likely to be el-derly (≥70 years), immunized, obese, have heterozygous sickle cell disease, or polycystic kidney disease (p < 0.05). Mean cold ischemia time decreased (p = 0.009), while warm ischemia time increased (p < 0.001). Graft survival re-mained stable, with 97.5% at 6 months and 89.8% at 4 years for transplants before 2020, versus 100% and 96.9%, respectively, after 2020 (p = 0.160). Patient survival did not differ between periods (p = 0.199). Independent factors associ-ated with mortality included recipient age ≥ 60 years, diabetes, graft failure, transplantation before 2020, cold ischemia time ≥ 1200 minutes, and graft py-elonephritis. Despite an increased proportion of transplants with expanded criteria after 2020, graft and patient survival were not adversely affected.

Abstract: Background: Chyle leakage is known to be a rare postoperative complication following liver transplantation (LT), and continuously leaked large quantities of chyle leakage can worsen prognosis. However, there is no explicit understanding of its mechanism and no existing reports showing the influence of chyle leakage after LT on blood concentration of the drug tacrolimus. Case presentation: Despite escalating tacrolimus daily dose to 4.0 mg with CYP3A5 inhibitor, blood concentrations remained subtherapeutic (1.7–2.5 ng/mL) during active leakage. Conservative treatments failed, prompting intraperitoneal injection of erythromycin (0.75 g)-25% glucose solution (40 mL every other day). Following three treatments, chylous drainage diminished significantly, and tacrolimus concentrations abruptly increased to 14.7 ng/mL 2 days after leakage resolved. Dose adjustments subsequently stabilized levels at 4.6–6.2 ng/mL with daily dose of 2.0mg. Conclusions: Intraperitoneal injection of erythromycin hypertonic solution may promote lymphatic fistula closure via chemical stimulation. Chyle leakage may reduce tacrolimus blood concentration through drug loss in chylous fluid. This case highlights the need for clinical attention to the association between chyle leakage and immunosuppressant concentrations, though further studies are required for validation.

Abstract: Polyomavirus-associated nephropathy was first reported more than 50 years ago, however it still represents a cause of renal injury, with occurrence rates of 1%-10%, particularly in the firs two years following kidney transplantation. The role played by immunesuppression in viral reactivation is well aknowledged and the modulation of immunesuppression level is the main strategy for the management. Viral and immu-nological evaluation are fundamental for optimizing the diagnostic and clini-cal-therapeutic pathway. In this review, main features of polyomavirus BK and asso-ciated nephropathy will be addressed from a virological point of view.

Abstract: Background: The accurate evaluation of anti-ABO antibodies is essential for risk stratification in ABO-incompatible (ABOi) transplantation. Historically, hemaggluti-nation-based titration has been the cornerstone of such an assessment; however, dif-ferent tools are being evaluated in this context. In recent years, several novel methods have been reported. Methods: A narrative review was conducted using PubMed, Scopus, and Google Scholar, focusing on recent studies evaluating anti-ABO antibody measurement tech-niques in the context of ABOi organ transplantation. Results: In addition to the conventional tube method, techniques such as column ag-glutination technology, flow cytometry, and enzyme-linked immunosorbent assay are utilized for anti-ABO antibody assessment. However, any particular technique, sig-nificant interinstitutional and interoperator variabilities have been reported due to differences in the detailed protocols and the inherently subjective nature of some techniques. Moreover, these assays are based on the antibody binding to ABO anti-gens expressed on red blood cells, which might not accurately reflect the clinical con-text of organ transplantation. In recent years, technological advances have enabled the development of novel assays evaluating antibody responses specifically against the ABO antigens expressed on vascular endothelial cells. These include glycan mi-croarrays, which differentiate responses by ABO antigen subtypes, and CD31-based microarrays, wherein recombinant CD31 proteins expressing ABO antigens are im-mobilized. These approaches are applied to assess clinically relevant anti-ABO anti-bodies in the context of ABOi organ transplantation. Conclusions: The objective evaluation of antibody titers against ABO antigens on vascular endothelial cells might not only enable a more accurate risk assessment but also facilitate meaningful comparisons between institutions.

Abstract: Selecting donor organs is both a science and an art. The calculus is often complex evaluating recipients’ acute needs and the quality and risks of the donor organs. Sarcoidosis is usually a disease of exclusion and considered an idiopathic inflammatory granulomatous process frequently in the lung but often with multiorgan involvement. New insights into the interplay between the environmental or occupational antigens and the susceptible genetic host in sarcoidosis have come to light. One such occupational antigen with mixed data regarding the risk of developing sarcoidosis after exposure is silica dust. Despite strict exposure limitations enforced in the United States and several other governing bodies worldwide, clusters of silicosis are on the rise due to engineered stone (quartz), which contain silica particles that when cut can create a dust that can exceed exposure limitations. Data on the quartz-sarcoidosis relationship is minimal, and thus questions exist regarding the risk of silica dust exposure and the risk of sarcoidosis. Silicosis tends to only affect the lungs, preventing them usually from being transplanted while sarcoidosis is recognized as having a high probability of multiple organ involvement. An index case discovered during organ recovery highlights the possible association between silica exposure and sarcoidosis. This case also examples the complexity of donor organ evaluation and the challenges in organ procurement from exposed individuals.

Abstract: BK virus-associated hemorrhagic cystitis (BKV-HC) is a significant complication following alloge-neic hematopoietic cell transplantation (HCT), typically resulting from the reactivation of latent BK polyomavirus in the context of profound immunosuppression. This review addresses three core re-search questions: (1) What are the most accurate and practical diagnostic strategies for identifying BKV-HC in HCT recipients? (2) Which therapeutic interventions demonstrate the greatest efficacy and safety in clinical practice? (3) How can emerging immunological insights inform future indi-vidualized treatment approaches? Current diagnostic approaches rely on clinical assessment combined with quantitative PCR to detect active viral replication in urine or plasma, with exclusion of alternative causes of hematuria and renal injury. BKV-HC presents with a wide spectrum of clinical severity and contributes substan-tially to morbidity, prolonged hospitalization, and healthcare resource utilization. While reduction of immunosuppression remains the primary intervention, antiviral agents such as cidofovir, leflunomide, and fluoroquinolones have shown inconsistent benefits. Supportive strategies, in-cluding bladder irrigation, and novel immunotherapies targeting virus-specific immune responses are under active investigation. Given the disease’s complex pathogenesis and the absence of standardized treatment protocols, future research should prioritize prospective trials to establish validated viral load thresholds, op-timize therapeutic algorithms, and explore the utility of immune monitoring to inform personalized management.

Abstract: The reactivation of BK polyomavirus (BKPyV) during severe immunosuppression plays a crucial role in two significant syndromes observed in transplant recipients: BK polyomavirus-associated nephropathy (BKPyVAN) in kidney transplant patients and BK polyomavirus-associated hemorrhagic cystitis (BKPyV-HC) in hematopoietic cell transplant (HCT) recipients. This review aims to summarize current understanding and lingering ambiguity by looking at three primary questions: (1) In cases with BKPyV-related illnesses in transplant patients, which diagnostic methods have the best track record of accuracy and success? (2) Which therapy approaches have the best track records of safety and efficacy in real-world clinical settings? (3) What can immunological research teach us about the development of future tailored treatments? Diagnosis involves the patient's appearance, ruling out other potential causes, and employing quantitative PCR to identify active viral replication in urine or plasma. BKPyV-HC can vary from self-limited hematuria to potentially fatal bleeding, while BKPyVAN may lead to loss and dysfunction of the allograft. Reducing immunosuppression remains the key aspect of treatment. However, the effectiveness of antivirals (such cidofovir and leflunomide) is not always the same, and supporting measures depend on the syndrome. Researchers are looking into new immunotherapies, such as virus-specific cytotoxic T cells. Due to the intricate viro-immunopathology and lack of defined treatment regimens, future initiatives should focus on prospective studies to establish validated thresholds, enhance management algorithms, and integrate immune surveillance into individualized therapy.

Abstract: Background/Objectives: The extended-release once-daily tacrolimus (LCP-Tac) formulation demonstrates enhanced bioavailability and a sustained pharmacokinetic profile compared to the immediate-release twice-daily tacrolimus (IR-Tac) formulation. Switching from IR-Tac to LCP-Tac is emerging as a viable immunosuppressive strategy in clinical settings. This study aimed to examine the influence of genetics and other covariates on the general conversion ratio of 1:0.7. Methods: A population pharmacokinetic model was developed using rich sampling data from 30 stable renal transplant patients who received both IR-TAC and LCP-TAC formulations. Results: The pharmacokinetic (PK) profile was best described by a two-compartment model with first-order absorption and linear elimination for both formulations. The model effectively captured differences in the absorption phases of the two formulations by estimating distinct absorption rate constants and lag times. It also accounted for circadian rhythm effects on apparent elimination clearance and absorption rate constants for IR-Tac. A key finding was the significant impact of the CYP3A5 genetic polymorphism on apparent clearance and the dose conversion rate from IR-Tac to LCP-Tac. CYP3A5*1 expressers had higher clearance and achieved lower exposure with the same IR-Tac dose regimen compared to non-expressers. Conclusion: The enhanced oral bioavailability of LCP-Tac necessitates dose reductions across the patient cohort following conversion from IR-Tac. However, CYP3A5*1 expressers require a more pronounced reduction (1:0.6 conversion ratio) compared to non-expressers (1:0.7) to maintain steady-state concentrations achieved initially with IR-Tac.

Abstract: In renal transplant recipients (RTRs), kidney graft failure and cardiovascular disease are prevalent and associated with morbidity and mortality. Objectives:The objective of the study was to evaluate biomarkers, such as cardiac troponin T (cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), to identify RTRs who are at greater risk of experiencing unfavorable outcomes, including all-cause mortality, renal, and cardiovascular (CV) events, as well as to assess the influence of these biomarkers on overall and death-censored graft survival. Patients and methods: A total of 342 stable RTRs were enrolled in this study, with a mean follow-up time of 48.4 months and a median follow-up time of 54 months. The probability of death, CV, and renal events at 4.9 years was calculated using Kaplan-Meier analysis for the group defined by cTnT and NT-proBNP levels above the cutoff values. Results: The probability of death and CV events was 23%, 20%, and 29%, 19%, for cTnT and NT-proBNP levels above the cutoff values, respectively. The probability of renal events, overall graft survival, and death-censored graft survival was 68%, 38%, 25%, and 63%, 41%, 27%, respectively. Conclusion: These data suggest that cTnT and NT-proBNP could potentially identify patients at high risk for death, CV, and renal events, as well as for overall graft survival and death-censored graft survival.

Abstract: Historically, colorectal liver metastases (CRLM) have been considered a contraindication for liver transplantation (LT), given the limited organ supply and poor oncologic efficacy. Recent studies, however, have demonstrated that highly selected patients with unresectable CRLM can achieve remarkable long-term survival following LT, often surpassing outcomes seen with conventional systemic therapies. This review explores the evolving role of LT for the treatment of unresectable CRLM, examining patient selection criteria, overall survival, disease-free survival, recurrence patterns, and emerging biomarkers that may guide transplant eligibility. Additionally, we discuss innovations in organ utilization, including living donor LT and machine perfusion strategies, to expand access while mitigating ethical concerns surrounding organ allocation. As LT for CRLM transitions from experimental protocols to clinical application, this review highlights key challenges and opportunities that will shape its future role in the field of transplant oncology.

Abstract: A 51-year-old gentleman with complications from long-standing type 1 diabetes mellitus underwent simultaneous pancreas and pre-emptive kidney transplant at our center, with rabbit anti-thymocyte globulin and methylprednisolone induction. Three months post-transplant he presented for evaluation of a diffuse lichenoid cutaneous eruption. An extensive infectious workup was unrevealing, and skin punch biopsy showed interface vacuolar dermatitis, suggestive of graft-versus-host disease (GVHD) of the skin. The patient then developed acute transaminitis and neutropenia, and biopsies of the liver and bone marrow done subsequently also confirmed GVHD of these organs, with microchimerism assay on the bone marrow showing 43% of the T-cells were of donor origin. The patient improved with initiation of systemic and topical corticosteroids. Although a rare entity in solid organ transplantation, this case highlights the importance of considering solid organ transplant graft-versus-host disease (SOT-GVHD), particularly in patients receiving organs with a larger volume of passenger donor T-lymphocytes, such as is seen with intestinal, liver, and pancreas transplants.

Abstract: Background/Objectives: Hip fractures in elderly patients are associated with high morbidity and mortality, often worsened by perioperative anemia. Although restric-tive transfusion strategies are recommended, the role of preoperative intravenous iron, particularly ferric carboxymaltose (FCM) remains unclear. This study aimed to investigate whether preoperative IV FCM reduces mortality and transfusion requirements in geriatric hip fracture patients managed under a restrictive transfusion strategy. Methods: In this prospective, randomized controlled trial, 220 patients aged ≥65 years undergoing surgery for hip fractures were allocated to receive either a single 1000 mg dose of intravenous FCM approximately 12 hours before surgery or no iron supplementation. All patients were managed with a standardized restrictive transfusion strategy. Primary outcome was all-cause mortality at 6 and 12 months. Secondary outcomes included perioperative transfusion requirement, hemoglobin trends, and length of hospital stay. Results: The FCM group demonstrated significantly lower mortality at both 6 months (22.9% vs. 39.0%, p = 0.011) and 12 months (28.4% vs. 42.9%, p = 0.028) compared to the control group. Multivariate logistic regression identified preoperative FCM administration as an independent protective factor for mortality. Transfusion rates (30.9% vs. 45.5%, p = 0.02) and transfusion index were significantly lower in the FCM group. Discharge hemoglobin levels were higher in the FCM group, although no significant difference was observed at 6-week follow-up. The difference in hospital stay duration did not reach statistical significance. Conclusions: Preoperative intravenous FCM administration could reduce both short- and long-term mortality and transfusion needs in geriatric hip fracture patients managed under a restrictive transfusion protocol. These findings support further investigation of FCM as a component of perioperative blood management in this high-risk population.