Abstract

OBJECTIVES One of the treatment modalities that can be used for hyperleukocytosis is leukapheresis. However, the result of studies showing the benefit of early mortality through the use of leukapheresis versus no leukapheresis is still inconclusive. Hence, we aimed to conduct a systematic review with meta-analysis to determine the effect of leukapheresis on early mortality in AML patients with hyperleukocytosis. METHODS We conducted a literature search on five databases (PubMed, EBSCOhost, Scopus, Clinicalkey, and JSTOR) up to October 2021 for studies comparing early mortality outcomes between hyperleukocytosis AML patients treated with leukapheresis versus no leukapheresis. Summary odds ratios (OR) and 95% confidence intervals (CI) were calculated using random-effects models. Heterogeneity tests were presented in I(2) value and publication bias was analyzed using a funnel plot. RESULTS Eleven retrospective cohort studies were eligible based on the inclusion and exclusion criteria. Pooled analysis showed that there was no significant difference in early mortality between patients receiving leukapheresis and not receiving leukapheresis in studies using hyperleukocytosis cutoff of 95,000/mm(3) or 100,000/mm(3) (OR: 1.17; 95% CI: 0.74-1.86; p: 0.50; I(2): 0%). Similarly, studies using hyperleukocytosis cutoff of 50,000/mm(3) also showed no benefits of early mortality (OR: 0.67; 95% CI: 0.43-1.05; p: 0.08; I(2): 0%). Most of the studies used had a moderate risk of bias due to being observational studies. Funnel plot showed an indication of publication bias on studies using hyperleukocytosis cutoff of ≥50,000/mm(3). CONCLUSION The use of leukapheresis does not provide early mortality benefit in adult AML patients with hyperleukocytosis.

Abstract

BACKGROUND Combining pathogen reduction and automated separation of whole blood (WB), together with the use of improved additive solutions, may increase reproducibility and extend shelf-life of blood components. MATERIALS AND METHODS Forty WB units were collected from volunteer donors and randomised 1:1 into two groups: 1) pathogen reduction with riboflavin and ultraviolet light (PRT); or 2) no treatment (Control). After two hours (h) at room temperature, all units underwent fully automated separation into red blood cell concentrate (RBCC), plasma and leukopack components. RBCCs were leukoreduced and stored in phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) solution while plasma units were shock frozen within 8 h of collection and stored at ≤ -25°C. RBCCs were sampled on day 1 and weekly thereafter until day 42, while plasma was sampled on days 1 and 30. The main study objective was to assess the in vitro quality of separated RBCCs using biochemical and haematological parameters. Plasma protein content after one cycle of freeze-thaw was also analysed. RESULTS The quality of RBCCs was largely comparable between the PRT and Control groups, except for a significantly higher degree of haemolysis and extracellular potassium levels in the PRT group after 35 days of storage. While potassium concentration was significantly higher in the PRT group at all timepoints, the degree of haemolysis exceeded the accepted European threshold (i.e., <0.8% of red cell mass in ≥90.0% of tested units) after day 35. Most plasma protein levels were significantly lower in the PRT than the Control group at both day 1 and day 30. DISCUSSION Pathogen reduction with riboflavin and ultraviolet light treatment of WB can be combined with fully automated separation to obtain RBCCs that may be stored for up to 35 days in PAGGSM solution with acceptable quality, comparable to that of RBCCs from untreated blood. The relative differences between factor concentrations in plasma from the PRT and the Control groups were similar during the 30-day storage.

Abstract

PURPOSE Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery. MATERIALS AND METHODS Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia. RESULTS The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed. CONCLUSIONS In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.

Abstract

IMPORTANCE Clinical prediction models, or risk scores, can be used to risk stratify patients with lower gastrointestinal bleeding (LGIB), although the most discriminative score is unknown. OBJECTIVE To identify all LGIB risk scores available and compare their prognostic performance. DATA SOURCES A systematic search of Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 1990, through August 31, 2021, was conducted. Non-English-language articles were excluded. STUDY SELECTION Observational and interventional studies deriving or validating an LGIB risk score for the prediction of a clinical outcome were included. Studies including patients younger than 16 years or limited to a specific patient population or a specific cause of bleeding were excluded. Two investigators independently screened the studies, and disagreements were resolved by consensus. DATA EXTRACTION AND SYNTHESIS Data were abstracted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline independently by 2 investigators and pooled using random-effects models. MAIN OUTCOMES AND MEASURES Summary diagnostic performance measures (sensitivity, specificity, and area under the receiver operating characteristic curve [AUROC]) determined a priori were calculated for each risk score and outcome combination. RESULTS A total of 3268 citations were identified, of which 9 studies encompassing 12 independent cohorts and 4 risk scores (Oakland, Strate, NOBLADS [nonsteroidal anti-inflammatory drug use, no diarrhea, no abdominal tenderness, blood pressure ≤100 mm Hg, antiplatelet drug use (nonaspirin), albumin <3.0 g/dL, disease score ≥2 (according to the Charlson Comorbidity Index), and syncope], and BLEED [ongoing bleeding, low systolic blood pressure, elevated prothrombin time, erratic mental status, and unstable comorbid disease]) were included in the meta-analysis. For the prediction of safe discharge, the AUROC for the Oakland score was 0.86 (95% CI, 0.82-0.88). For major bleeding, the AUROC was 0.93 (95% CI, 0.90-0.95) for the Oakland score, 0.73 (95% CI, 0.69-0.77) for the Strate score, 0.58 (95% CI, 0.53-0.62) for the NOBLADS score, and 0.65 (95% CI, 0.61-0.69) for the BLEED score. For transfusion, the AUROC was 0.99 (95% CI, 0.98-1.00) for the Oakland score and 0.88 (95% CI, 0.85-0.90) for the NOBLADS score. For hemostasis, the AUROC was 0.36 (95% CI, 0.32-0.40) for the Oakland score, 0.82 (95% CI, 0.79-0.85) for the Strate score, and 0.24 (95% CI, 0.20-0.28) for the NOBLADS score. CONCLUSIONS AND RELEVANCE The Oakland score was the most discriminative LGIB risk score for predicting safe discharge, major bleeding, and need for transfusion, whereas the Strate score was best for predicting need for hemostasis. This study suggests that these scores can be used to predict outcomes from LGIB and guide clinical care accordingly.

Abstract

BACKGROUND Treatment with erythropoietin is well established for anemia in chronic kidney disease patients but not well studied in acute kidney injury. METHODS This is a multicenter, randomized, pragmatic controlled clinical trial. It included 134 hospitalized patients with anemia defined as hemoglobin < 11 g/dL and acute kidney injury defined as an increase of serum creatinine of ≥ 0.3 mg/dL within 48 h or 1.5 times baseline. One arm received recombinant human erythropoietin 4000 UI subcutaneously every other day (intervention; n = 67) and the second received standard of care (control; n = 67) during the hospitalization until discharge or death. The primary outcome was the need for transfusion; secondary outcomes were death, renal recovery, need for dialysis. RESULTS There was no statistically significant difference in transfusion need (RR = 1.05, 95%CI 0.65,1.68; p = 0.855), in renal recovery full or partial (RR = 0.96, 95%CI 0.81,1.15; p = 0.671), in need for dialysis (RR = 11.00, 95%CI 0.62, 195.08; p = 0.102) or in death (RR = 1.43, 95%CI 0.58,3.53; p = 0.440) between the erythropoietin and the control group. CONCLUSIONS Erythropoietin treatment had no impact on transfusions, renal recovery or mortality in acute kidney injury patients with anemia. The trial was registered on ClinicalTrials.gov (NCT03401710, 17/01/2018).

Abstract

BACKGROUND Roxadustat (ROX) is a new medication for anemia as a complication of chronic kidney disease (CKD). Our meta-analysis aims to evaluate the efficacy and safety of ROX, especially on the cardiovascular risks, for anemia in NDD-CKD patients. METHODS Electronic databases were searched systematically from inception to July 2021 to look for randomized control trials (RCTs) that evaluated ROX NDD-CKD patients. Hemoglobin level and iron utilization parameters, including ferritin, serum iron, transferrin saturation (TSAT), total iron-binding capacity (TIBC), transferrin, and hepcidin were analyzed for efficacy. Pooled risk ratios (RRs) and standardized mean differences (SMDs) were calculated and presented with their 95% confidential intervals (CIs). RESULTS Nine RCTs included a total of 3,175 patients in the ROX group and 2,446 patients in the control group. When compared the control group, ROX increased Hb level significantly (SMD: 1.65; 95% CI: 1.08, 2.22; P< 0.00001) and improved iron utilization parameters by decreasing ferritin (SMD: -0.32; 95% CI: -0.51, -0.14; P = 0.0006), TSAT (SMD: -0.19; 95% CI: -0.32, -0.07; P = 0.003), and hepcidin (SMD: -0.74; 95% CI: -1.09, -0.39; P< 0.0001) and increasing TIBC (SMD: 0.99; 95% CI: 0.76, 1.22; P< 0.00001) and transferrin (SMD: 1.20; 95% CI: 0.70, 1.71; P< 0.00001). As for safety, ROX was associated with higher serious adverse effects (RR: 1.07; 95% CI: 1.01, 1.13; P = 0.01), deep venous thrombosis (DVT) (RR: 3.80; 95% CI: 1.5, 9.64; P = 0.08), and hypertension (HTN) (RR: 1.37; 95% CI: 1.13, 1.65; P = 0.001). CONCLUSION We concluded that ROX increased Hb level and improved iron utilization parameters in NDD-CKD patients, but ROX was associated with higher serious adverse effects, especially DVT and HTN. Our results support the use of ROX for NDD-CKD patients with anemia. However, higher-quality RCTs are still needed to ensure its safety and risk of thrombosis.

Abstract

INTRODUCTION Exsanguination is the most preventable cause of death. Paradigms such as STOP THE BLEED recognize increased responsibility among the less experienced with Wound Packing (WP) being a critical skill. As even trained providers may perform poorly, we compared Video-modelling (VM), a form of behavioural modelling involving video demonstration prior to intervention against remote telementoring (RTM) involving remote real-time expert-guidance. METHODS Search and Rescue (SAR-Techs), trained in WP were asked to pack a wound on a standardized simulator randomized to RMT, VM, or control. RESULTS 24 SAR-Techs (median age 37, median 16.5 years experience) participated. Controls were consistently faster than RTM (p = 0.005) and VM (p = 0.000), with no difference between RTM and VM. However, 50% (n = 4) Controls failed to pack properly, compared to 100% success in both VM and RTM, despite all SAR-Techs feeling the task was "easy". DISCUSSION Performance of a life-saving technique was improved through either VM or RTM, suggesting that both techniques are beneficial and complementary to each other. Further work should be extended to law enforcement/lay public to examine logistical challenges.

Abstract

BACKGROUND Early hemorrhage control after interpersonal violence is the most urgent requirement to preserve life and is now recognized as a responsibility of law enforcement. Although earlier entry of first responders is advocated, many shooting scenes remain unsafe for humans, necessitating first responses conducted by robots. Thus, robotic hemorrhage control warrants study as a care-under-fire treatment option. METHODS Two bomb disposal robots (Wolverine and Dragon Runner) were retrofitted with hemostatic wound clamps. The robots' ability to apply a wound clamp to a simulated extremity exsanguination while controlled by 4 experienced operators was tested. The operators were randomly assigned to perform 10 trials using 1 robot each. A third surveillance robot (Stair Climber) provided further visualization for the operators. We assessed the success rate of the application of the wound clamp to the simulated wound, the time to application of the wound clamp and the amount of fluid loss. We also assessed the operators' efforts to apply the wound clamp after an initial attempt was unsuccessful or after the wound clamp was dropped. RESULTS Remote robotic application of a wound clamp was demonstrated to be feasible, with complete cessation of simulated bleeding in 60% of applications. This finding was consistent across all operators and both robots. There was no difference in the success rates with the 2 robots (p = 1.00). However, there were differences in fluid loss (p = 0.004) and application time (p < 0.001), with the larger (Wolverine) robot being faster and losing less fluid. CONCLUSION Law enforcement tactical robots were consistently able to provide partial to complete hemorrhage control in a simulated extremity exsanguination. Consideration should be given to using this approach in care-under-fire and care-behind-the-barricade scenarios as well as further developing the technology and doctrine for robotic hemorrhage control.

Abstract

AIM: We intended to provide the clinical evidence that artificial intelligence (AI) could be used to assist doctors in the diagnosis of intracerebral hemorrhage (ICH). METHODS Studies published in 2021 were identified after the literature search of PubMed, Embase, and Cochrane. Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) was used to perform the quality assessment of studies. Data extraction of diagnosis effect included accuracy (ACC), sensitivity (SEN), specificity (SPE), positive predictive value (PPV), negative predictive value (NPV), area under curve (AUC), and Dice scores (Dices). The pooled effect with its 95% confidence interval (95%CI) was calculated by the random effects model. I-Square (I (2)) was used to test heterogeneity. To check the stability of the overall results, sensitivity analysis was conducted by recalculating the pooled effect of the remaining studies after omitting the study with the highest quality or the random effects model was switched to the fixed effects model. Funnel plot was used to evaluate publication bias. To reduce heterogeneity, recalculating the pooled effect of the remaining studies after omitting the study with the lowest quality or perform subgroup analysis. RESULTS Twenty-five diagnostic tests of ICH via AI and doctors with overall high quality were included. Pooled ACC, SEN, SPE, PPV, NPV, AUC, and Dices were 0.88 (0.83∼0.93), 0.85 (0.81∼0.89), 0.90 (0.88∼0.92), 0.80 (0.75∼0.85), 0.93 (0.91∼0.95), 0.84 (0.80∼0.89), and 0.90 (0.85∼0.95), respectively. There was no publication bias. All of results were stable as revealed by sensitivity analysis and were accordant as outcomes via subgroups analysis. CONCLUSION Under the background of the fourth industrial revolution, AI might be an effective and efficient tool to assist doctors in the clinical diagnosis of ICH.

Abstract

BACKGROUND With the increasing evidence provided by recent high-quality studies, the intravenous iron appears to be a reliable therapy for blood administration in geriatric patients with hip fractures. Here, this systematic review and meta-analysis were aimed to assess the effectiveness and safety of intravenous iron in geriatric patients sustaining hip fractures. METHODS Potential pertinent literatures evaluating the effects of intravenous iron in the geriatric patients undergoing hip fractures were identified from Web of Science, PubMed, Embase, and Scopus. We performed a pairwise meta-analysis using fixed- and random-effects models, and the pooling of data was carried out by using RevMan 5.1. RESULTS Four randomized controlled trials and four observational studies conform to inclusion criteria. The results of meta-analysis showed that intravenous iron reduced transfusion rates compared to the control group, yet the result did not reach statistical significance. The intravenous iron was related to lower transfusion volumes, shorter length of stay, and a reduced risk of nosocomial infections. And there was no significant difference in terms of the mortality and other complications between the treatment group and the control group. CONCLUSION Current evidence suggests that intravenous iron reduces the transfusion volume, length of hospital stay, and risk of nosocomial infections. It takes about 7 days for intravenous iron to elevate hemoglobin by 1 g/dl and about 1 month for 2 g/dl. The safety profile of intravenous iron is also reassuring, and additional high-quality studies are needed.