Collection Bag Research Articles

Extracorporeal Photopheresis with 5-Aminolevulinic Acid in Crohn's Disease-A First-in-Human Phase I/II Study.

Background/Objectives: With the increasing prevalence of Crohn's disease (CD), treatment options for patients who fail conventional and advanced therapy are highly needed. Therefore, we explored the safety and efficacy of extracorporeal photopheresis (ECP) using 5-aminolevulinic acid (ALA) and blue light (405 nm). Methods: Patients with active CD who failed or were intolerant to biological therapy were eligible. Mononuclear cells (90 mL) were collected from each patient using a Spectra Optia® apheresis system and diluted with 100 mL of 0.9% sodium chloride in a collection bag. The cells were incubated with ALA at a concentration of 3 millimolar (mM) for 60 min ex vivo and illumination with an LED blue light (405 nm) source (BLUE-PIT®) before reinfusion to the patient. Recording of vital signs and adverse events were regularly performed. At week 13, we assessed the patients with colonoscopy, the Harvey Bradshaw Index (HBI), the Inflammatory Bowel disease Health Related Quality of Life Questionnaire, and the measurement of serum C-reactive protein and fecal calprotectin (FC) levels. Biopsies of the intestines were taken for immunohistochemistry. Results: Seven patients were included. Four patients completed the treatments, with a total of 24 treatments. Three of the four patients achieved a favorable response, including a lower HBI, lower FC levels, and/or endoscopic improvement. No significant adverse events were observed. The remaining three patients received only one, three, or five treatments due to technical difficulties, medical reasons, or the withdrawal of informed consent. Conclusions: ALA-based ECP appears safe and seems to give some clinical improvement for the patients with active CD who failed to respond to conventional and advanced therapies.

Concentration of kidney markers and detection of exosomes in urine samples collected in cotton wool balls in preterm and term neonates

Collecting urine samples in neonates by catheterisation or suprapubic puncture causes trauma, whereas self-adhesive collection bags can damage fragile skin. An alternative method is the collection of samples from urine-soaked cotton wool balls placed in diapers. The aim of this study was to compare the concentration of albumin, creatinine, neutrophil gelatinase-associated lipocalin (NGAL), and uromodulin between clean-catch urine and samples collected in cotton balls in neonates and assess the efficiency of exosome extraction. Standard clean-catch urine samples (SSs) were assayed for albumin, creatinine, NGAL, and uromodulin using commercial ELISA kits. Concentrations were compared to the same urine samples extracted immediately from soaked cotton wool balls (sample 2, S2) or the urine extracted from cotton wool balls placed in diaper in a warm incubator for 2 h before extraction (sample 3, S3). Exosomes were extracted from all three samples of one patient for visualisation by electron microscopy. Twenty-six infants (17 males) of median gestational age at birth of 32+1 weeks had urine collected at a median age of 29 days at 37+6 weeks corrected age. Concentrations in S2 and S3 were within 10% of the concentration of SS in 46% and 35% of specimens for albumin, 69% and 58% for creatinine, 12% and 12% for NGAL, and 27% and 15% for uromodulin, respectively, without consistent positive or negative bias. Urine albumin/creatinine ratios (UACRs) were 4.3% less in S2 and 4.5% less in S3 than in SS. Exosomes were extracted and visualised from all three sample types. Neonatal urine samples extracted from cotton wool balls can be used to screen for relevant albuminuria ​but provide imprecise estimates of NGAL and uromodulin. The proof of exosome extraction from urine collection in cotton wool balls opens the potential to examine exosomal cargo.

Proof of concept of an experimental prototype for the prevention of parastomal hernia.

The aim of this study was to analyse the complications and problems associated with the use of an experimental prototype designed for the prevention of parastomal hernia (PSH), one of the most frequent complications in ostomates. A single-centre, non-comparative, proof-of-concept interventional pilot study of an experimental prototype designed to be used in conjunction with an abdominal compression binder to prevent PSH was conducted. The "Ostomy Fixation Device for Hernia Prevention" (patent P201531826) is a semi-rigid ostomy protector, to be used in conjunction with a compression binder. It is designed to adapt to the dimensions of standard ostomy bags from different brands and serves to transmit, in a localised manner, the support coming from the compression binder in the peristomal area without putting pressure on the collection bag. The main outcome measures were efficacy, safety, and patient-users' opinion/perception. Ten patients were studied for 12 months. Mean age was 61 years (± 11.59), 70% (7) were male, 80% (8) ostomised for colorectal cancer, 90% (9) underwent planned surgery and 80% (8) had a colostomy. the incidence of HPE was 10% (1). no participant experienced pain, discomfort, itching, stinging, leakage, pouch detachment, allergy to components, or injury to the stoma or peristomal skin due to rubbing or pressure. 90% (n = 9) were considered "very satisfied" or "satisfied" with the device. An innovative device designed in collaboration between healthcare professionals and end-users has been shown to be safe and effective in reducing PSH in the group of ostomates studied.

Tranexamic acid in preventing postpartum blood loss in vaginal delivery: a double-blinded randomized controlled trial

Postpartum hemorrhage (PPH) is an obstetrical emergency that occurs in 1% to 10% of all deliveries and contributes to nearly one-quarter of all maternal deaths worldwide. Tranexamic acid has been established as an adjunct in the treatment of PPH but its role in its prevention of PPH following vaginal delivery has not been widely studied. This study aimed to assess the effect of prophylactic tranexamic acid (1 g) along with active management of the third stage of labor in reducing postpartum blood loss and the incidence of postpartum hemorrhage after vaginal delivery. In this randomized controlled trial, 650 women with singleton pregnancies at ≥34 weeks of gestation who were undergoing vaginal delivery were included. Eligible women were randomly assigned to receive either 1 g of tranexamic acid or placebo intravenously along with active management of the third stage of labor. Calibrated blood collection bags were used to measure postpartum blood loss during the third and fourth stages of labor. Of 886 women approached for the study, 650 who met the inclusion criteria were enrolled, and 320 in group A and 321 in group B were analyzed. The maternal characteristics were similar between the groups. The mean blood loss did not differ significantly between the intervention and placebo groups (378.5±261.2 mL vs 383.0±258.9 mL; P=.93). The incidence of primary postpartum hemorrhage was comparable in both groups (15.9% in group A and 15.3% in group B; P=.814). The median quantitative decreases in hemoglobin levels within 12 to 24 hours after delivery were 0.60 g% (interquartile range, 0.40-0.90) in group A and 0.60 g% (interquartile range, 0.40-0.80) in group B, which were comparable in both groups (P=.95). The most common adverse effect reported was dizziness, and there was no thromboembolic event at 3 months follow-up in either group. The use of tranexamic acid as a prophylactic measure along with active management of the third stage of labor does not provide additional benefit in reducing the postpartum blood loss and incidence of postpartum hemorrhage after vaginal delivery. El resumen está disponible en Español al final del artículo.

Efficiency assessment of cord blood banking and compatibility with delayed cord clamping.

There is debate whether delayed umbilical cord clamping following delivery, the current gold standard, affects the proportion of cord blood units (CBU) suitable for public cord blood banking. This study was designed to assess the impact of delayed cord clamping on the number of CBU suitable for therapeutic uses. To minimize variability, data from the four most active collection centers within the Programa Concordia (Spain) were included. Data on CBU collected in utero from mothers following normal vaginal deliveries from July 2018 to December 2021 were analyzed. The weight of the collection bags (as a surrogate of volume) and total nucleated cell (TNC) count were analyzed according to three defined clamping times: 30 s, 60 s and ≥120 s. The CBU were stratified as suitable for stem cell transplantation (≥110 g and ≥1,500×106 TNC/unit) or other clinical applications (≥100 g but TNC count below the threshold). - There were 131 (18%), 548 (76%), and 40 (5%) CBU collected at 30 s, 60 s and ≥120 s, respectively. The median weight of the CBU decreased gradually with time, with a significant difference between units collected when the cord was clamped at 30 s or 60 s (p=0.036), so significantly fewer CBU met the minimal weight criterion (100 g) at 60 s than at 30 s (p=0.002). However, this was not reflected by the TNC available, resulting in non-statistical differences in CBU eligible for banking between these times. The major predictor of collection success was the neonate's birth-weight. -Despite decreases in the volume of cord blood collected when cord clamping at 30 s or 60 s, TNC count is maintained resulting in similar numbers of CBU eligible for banking. The different clamping delays investigated in this study are, therefore, compatible with public cord blood banking needs.

Mitigation of supply chain challenges in cell therapy manufacturing: perspectives from the cord blood alliance.

Cellular therapies rely on highly specialized supply chains that often depend on single source providers. Public cord blood banks (CBB) manufacturing the first cell therapy to be highly regulated by the FDA and related international agencies are a prime example of being subject to this phenomenon. In addition to banking unrelated donor cord blood units for transplantation, CBBs also source and characterize starting materials for supply to allogeneic cell therapy developers that often employ customized technologies offered by just a small number of manufacturers. As such, these supply chains are especially sensitive to even minor changes which often result in potential major impacts. Regulations can shape supply chain efficiencies, both directly via the definition of restricted technology and process requirements and indirectly by steering strategic business decisions of critical supply or service providers. We present 3 current supply chain issues with different root causes that are swaying efficiencies in cord blood banking and beyond. Specifically, the shortage of Hespan, a common supplement used in cord blood processing, the decision by the provider to stop supporting medical device marking of the Sepax system broadly used in cord blood banking, and a new European ruling on phasing out plasticizers that are critical for providing flexibility to cord blood collection bags, are all threatening downstream supply chain issues for the biologics field. We discuss overcoming these hurdles through the prism of unified mitigation strategies, defined, and implemented by multi-factorial teams and stakeholders, to negotiate resolutions with providers and regulators alike.

The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy in premenopausal women, diagnosed with uterine fibroids: protocol for a randomized controlled study (MyLacR study)

BackgroundThe oral gonadotropin-releasing hormone antagonist relugolix, which temporarily stops menstruation, is used to treat heavy menstrual bleeding, pelvic pressure, and low back pain in women with uterine fibroids. Treatment can also help women recover from low hemoglobin levels and possibly shrink the fibroids. However, evidence of preoperative use of relugolix before laparoscopic myomectomy is limited. Nevertheless, the treatment could reduce interoperative blood loss, decrease the risk of developing postoperative anemia, and shorten the operative time. Thus, we aim to test whether 12-week preoperative treatment with relugolix (40 mg orally, once daily) is similar to or not worse than leuprorelin (one injection every 4 weeks) to reduce intraoperative blood loss.MethodsEfficacy and safety of preoperative administration of drugs will be studied in a multi-center, randomized, open-label, parallel-group, noninferiority trial enrolling premenopausal women ≥ 20 years of age, diagnosed with uterine fibroids and scheduled for laparoscopic myomectomy. Participants (n = 80) will be recruited in the clinical setting of participating institutions. The minimization method (predefined factors: presence or absence of fibroids ≥ 9 cm and the International Federation of Gynecology and Obstetrics [FIGO] type 1–5 fibroids) with randomization is used in a 1:1 allocation. Relugolix is a 40-mg oral tablet taken once a day before a meal, for 12 weeks, up to the day before surgery. Leuprorelin is a 1.88 mg, or 3.75 mg subcutaneous injection, given in three 4-week intervals during patient visits before the surgery. For the primary outcome measure of intraoperative bleeding, the blood flow is collected from the body cavity, surgical sponges, and collection bag and measured in milliliters. Secondary outcome measures are hemoglobin levels, myoma size, other surgical outcomes, and quality-of-life questionnaire responses (Kupperman Konenki Shogai Index and Uterine Fibroid Symptoms—Quality of Life).DiscussionReal-world evidence will be collected in a clinical setting to use pre-treatment with an oral gonadotropin-releasing hormone antagonist to reduce intraoperative bleeding in women who undergo laparoscopic myomectomy.Trial registrationjRCTs031210564 was registered on 19 January 2022 in the Japan Registry of Clinical Trials (https://jrct.niph.go.jp).

236 The effects of replacing dried distiller’s grains with solubles with heat-treated soybean meal on nutrient intake and digestibility in forage-based diets

Abstract Cattle growth is calculated through dry matter intake, average daily gain and gain:feed measures that assume performance and digestibility are correlated. Hence, evaluating nutrient digestibility and flow provides additional explanations for subsequent growth performance. Therefore, five fistulated Jersey steers [Initial body weight (BW) = 288 ± 22 kg) fitted with ruminal, duodenal, and ileal cannulas were utilized in a 4 × 5 row-column design to determine intake and total tract nutrient digestibility when replacing dried distiller’s grains plus solubles (DDGS) with heat-treated soybean meal (TSBM) in forage-based growing diets. The 56-d study contained 4 periods, each period lasting 14 d [9 d of adaptation and 5 d of collection (d 0 to 4)]. Dietary treatments partially replaced DDGS, included at 16% diet dry matter (DM), with TSBM at increasing inclusion levels of 0 (TSBM0), 4 (TSBM4), 8 (TSBM8), and 12% (TSBM12) DM. Basal diets contained 43.5% corn silage, 36.5% oat hay, and 4% meal supplement (DM). Chromic oxide was incorporated into the diet daily at 0.25% DM as a digesta marker. Steers were housed in individual tie stalls during the 5-d collection period. Treatment diets were fed daily at 0800 h with orts being weighed at 0730 h and subsampled on d 0 to d 4 each period. Fecal collection bags were harnessed to each steer from d 0 to d 4 to collect fecal weight and subsampled twice daily (0700 and 1900 h). Digestibility and feed intake were analyzed utilizing the MIXED procedure of SAS with treatment and period as fixed effects and animal as a random effect. There were no differences (P ≥ 0.14) in DM, organic matter (OM), neutral detergent fiber (NDF), starch and nitrogen (N) intakes among treatments. Fecal DM, OM, NDF, starch, and N output resulted in no treatment effects (P ≥ 0.24). Subsequently, total tract apparent digestibility differences (P ≥ 0.32) were not detected for DM, OM, NDF, and starch content. However, N total tract apparent digestibility was significantly different (P < 0.03) with TSBM0 resulting in less N digestibility than TSBM12 (65.54% and 71.59%, respectively). Replacing a portion of DDGS with TSBM does not result in deleterious digestive effects in forage-based growing diets. As a result, the utilization of DDGS or TSBM as the primary protein source will depend on growth performance, feedstuff availability and economics.

Drawing and storing blood using a 3D printed bottle cap and a disinfected 500 mL drinking bottle: A proof-of-concept study.

Today, with wars raging in Ukraine and the Middle East, the demand for blood is high. Despite this, few companies produce the necessary equipment to draw, store, and transfuse whole blood. This study evaluated the safety and performance of a 3D printed bottle cap in conjunction with a water bottle and some available consumables to draw and store fresh whole blood. Bags of saline, and freshly donated whole blood, was transferred to the water bottle through a 3D printed bottle cap and stored for 72 h. An identical setup, transferring saline to a Terumo blood collection bag was used as control. Performance and safety were evaluated by calculating infusion rate and observing for backflow, respectively. The blood was also tested for hemolysis and bacterial growth at four sampling points. The cap-and-bottle setup was faster than control in terms of flow rate when transferring saline (1.53 vs. 1.81 mL/s, p < .001), and non-inferior to saline control when transfusing blood (1.53 vs. 1.49 mL/s, p = .641). We did not observe any risks of causing the donor iatrogenic harm, and there was no evidence of increased hemolysis. However, there were traces of bacterial contamination in three of six bottles. This study indicates that drawing blood is both feasible and safe, utilizing a 3D printed cap and bottle setup. Flow rate was faster than control, and mechanical properties of the blood were not affected. We were unable to determine the source of bacterial contamination in the blood.

Klotho as an Early Marker of Acute Kidney Injury Following Cardiac Surgery: A Systematic Review.

Acute kidney injury is a common complication following cardiac surgery (CSA-AKI). Serum creatinine levels require a minimum of 24-48 h to indicate renal injury. Nevertheless, early diagnosis remains critical for improving patient outcomes. A PRISMA-compliant systematic review of the PubMed and CENTRAL databases was performed to assess the role of Klotho as a predictive biomarker for CSA-AKI (end-of-search date: 17 February 2024). An evidence quality assessment of the four included studies was performed with the Newcastle-Ottawa scale. Among the 234 patients studied, 119 (50.8%) developed CSA-AKI postoperatively. Serum Klotho levels above 120 U/L immediately postoperatively correlated with an area under the curve (AUC) of 0.806 and 90% sensitivity. Additionally, a postoperative serum creatinine to Klotho ratio above 0.695 showed 94.7% sensitivity and 87.5% specificity, with an AUC of 92.4%, maintaining its prognostic validity for up to three days. Urinary Klotho immunoreactivity was better maintained in samples obtained via direct catheterization rather than indwelling catheter collection bags. Storage at -80 °C was necessary for delayed testing. Optimal timing for both serum and urine Klotho measurements was from the end of cardiopulmonary bypass to the time of the first ICU lab tests. In conclusion, Klotho could be a promising biomarker for the early diagnosis of CSA-AKI. Standardization of measurement protocols and larger studies are needed to validate these findings.

Donor Haemovigilance: A South Indian experience

Blood Donation from healthy screened donors is a well-tolerated procedure. However a small percentage may experience adverse donor reactions. Donor haemovigilance aims at identifying and documenting these reactions for donor safety.: This prospective cross-sectional study conducted at the Department of Transfusion Medicine &amp; Immunohaematology, Govt. Medical College, Kozhikode, Kerala for a one year study period from January 1st 2018 to December 31st 2018 included all adverse donor reactions and donor determinants in vasovagal reactions in allogenic whole blood donors. Donors were assessed as per the Standard Operating Procedure (S.O.P) based on national guidelines. 350ml collection bags were used. Vasovagal reactions were also graded as per the Blood Donation Reactions Inventory scale (B.D.R.I).: During the 1 year study period, 1.79% of 27,800 donors experienced adverse reactions. The most common symptoms were pre-syncopal 1.33% with syncope forming only 0.3% and local reactions 0.16%. Correlation with donor characteristics using Pearsons chi square test showed significance for female gender, first timers and lack of adequate sleep (&amp;#60;5 hrs). In our study there was no association with age (S.O.P guidelines) or food intake &amp;#60;4hrs.Our study reinforces the safety of blood donation with a very low prevalence of adverse reactions. Proper donor counseling and examination noting donor characteristics like adequate sleep, food intake and alleviation of fears and doubts of first timers can play a major role in further reducing the reaction rate and ensuring repeat donors, the need of the hour.

Reverse sheathing technique for iliocaval thrombectomy in the setting of IVC filters

The Inari ClotTriever system (Inari Medical, Irvine, California) is safe and effective for the treatment of DVT. However, because it consists of a 31 cm coring device and collection bag that must be extended for use, application may be precluded by available intravascular “running room”, such as in the presence of an IVC filter. Here we present a technique for bypassing IVC filters via retrograde deployment of the ClotTriever within a sheath, as illustrated in three cases. This technique extends the applicability of the ClotTriever to locations in which its length would otherwise preclude use.

When Minutes Matter: A Comparison of Whole Blood Collection Techniques.

Fast and reliable blood collection is critical to emergency walking blood banks (WBB) because mortality significantly declines when blood is quickly administered to a warfighter with hemorrhagic shock. Phlebotomy for WBB is accomplished via either the "straight stick" (SS) or "ruggedized lock" (RL) method. SS comprises a 16-gauge phlebotomy needle connected to a blood collection bag via tubing. The RL device collects blood through the same apparatus, but has a capped, intravenous (IV) catheter between the needle and the donor's arm. This is the first study to compare these two methods in battlefield-relevant metrics. Military first responders and licensed medical providers (N=86) were trained in SS and RL as part of fresh whole blood training exercises. Outcomes included venipuncture success rates, time to IV access, blood collection times, total time, and user preferences, using a within-subjects crossover design. Data were analyzed using ANOVA and nonparametric statistics at p<0.05. SS outperformed RL in first venipuncture success rates (76% vs. 64%, p=0.07), IV access times (448 [standard error of the mean; SE 23] vs. 558 [SE 31] s, p<0.01), and blood collection bag fill times (573 [SE 48] vs. 703 [SE 44] s, p<0.05), resulting in an approximate 3.5-minute faster time overall. Survey data were mixed, with users perceiving SS as simpler and faster, but RL as more reliable and secure. SS is optimal when timely collection is imperative, while RL may be preferable when device stability or replacing the collection bag is a consideration.

Evaluation of Methods to Obtain Peripheral Blood Mononuclear Cells From Deceased Donors for Tolerance-Induction Protocols.

Regulatory cell therapies have shown promise in tolerance-induction protocols in living donor organ transplantation. These protocols should be pursued in deceased donor transplantation. Donor peripheral mononuclear cells (PBMCs) are an optimal source of donor antigens for the induction of donor-specific regulatory cells. During the development of a regulatory cell tolerance-induction protocol with organs from deceased donors, we compared 3 methods of obtaining PBMCs from deceased donors focusing on cell yield, viability, and contamination of unwanted cell types. PBMC procurement methods: 1. During organ procurement at the time of cold perfusion, blood was collected from the vena cava and placed into a 10-liter blood collection bag, and thereafter transported to Karolinska University Hospital, where leukapheresis was performed (BCL). 2. Blood was collected via the vena cava into blood donation bags before cold perfusion. The bags underwent buffy coat separation and thereafter automated leukocyte isolation system (BCS). 3. To collect PBMCs, leukapheresis was performed via a central dialysis catheter on deceased donors in the intensive care unit (ICU) prior to the organ procurement procedure (LEU).All 3 methods to obtain PBMC from deceased donors were safe and did not affect the procurement of organs. BCL contained around 50% of NK cells in lymphocytes population. LEU had a highest yield of donor PBMC among 3 groups. LEU had the lower amount of granulocyte contamination, compared to BCS and BCL. Based on these results, we choose LEU as the preferred method to obtain donor PBMC in the development of our tolerance-induction protocol.

A Study on the Efficacy of Autologous Platelet-Rich Plasma Therapy in Erosive Lesions of Oral Cavity

ABSTRACT Autologous platelet-rich plasma (PRP) enhances the recruitment, proliferation, and differentiation of cells involved in tissue regeneration. Platelets contain a number of growth factors (GFs) including platelet-derived GFs and transforming GF which stimulate the proliferation of mesenchymal cells and vascular endothelial GFs and fibroblast GF which stimulate new blood vessel formation. This study evaluates the efficacy of intralesional injection of PRP in erosive lesions of the oral cavity. Five patients who attended the dental outpatient department of a tertiary care hospital were selected irrespective of age and sex diagnosed with erosive lichen planus, pemphigus, and three with desquamative gingivitis. Initial assessment including blood investigations and evaluation of extent, severity, activity, and pain was done. Autologous was prepared from 30 milliliters of whole blood collected into a 350 ml blood collection bag after modifying the anticoagulant to whole blood ratio. A soft spin followed by a hard spin in Thermo Scientific™ Heraeus™ Cryofuge™ was used for PRP preparation. On the same day, 0.5 mL PRP was directly injected onto the base and edge of the erosions using a 31 gauge needle. Patients were followed up and evaluated weekly. In pemphigus and desquamative gingivitis, PRP therapy relieved pain, burning sensation, and bleeding which was proven from Visual Analog Scale score and severity score. No adverse reactions were noted in patients. Autologous PRP poses no risk of allergic reaction and natural collagen is formed in response to the presence of activated platelets. The use of PRP is safe, efficient, and economic. The inability to prevent recurrent lesions and the inability to heal the lesion completely are the major drawbacks.

Pediatric Uropathogens and their Antimicrobial Susceptibility Pattern: Experience from an Impoverished District of Karachi, Pakistan.

Urinary tract infection (UTI) is the most common infection of the pediatric age group. Several factors linked to higher prevalence include poor personal hygiene, improper sanitation, lower socioeconomic status, and malnourishment. In addition to having a worse quality of life, the 1.8 million children who live in Karachi's Korangi district are routinely exposed to such factors. The study aims to evaluate the frequency of UTI and distribution of uropathogens along with their antimicrobial susceptibility pattern in patients presenting to a pediatric tertiary care center in the Korangi district of Karachi, Pakistan. The study employed an observational cross-sectional design. The study was conducted at the Microbiology laboratory of Sindh Institute of Child Health and Neonatology, Karachi, Pakistan from 1st January to 15th August 2023. Urine samples of patients 1 to 16 years of age were collected via midstream clean catch method and of patients from birth up to 1 year were collected in urine collection bags. The samples were cultured on Cystine Lactose Electrolyte Deficient (CLED) agar and antibiotic susceptibility testing was performed using the Kirby-Bauer Disc Diffusion method. A total of 457 urine samples were collected, of which 90 (19.7%) were positive for significant uropathogens. With a mean age of 4.6 years, majority of the culture-positive patients were female (n = 72; 80%). Enterobacterales were the most frequently isolated (n = 88; 95.6%), of which Escherichia coli was the most common (73.9%; n = 68). Citrobacter (n = 7; 7.6%), Klebsiella (n = 6; 6.5%), Serratia (n = 4; 4.3%), Proteus (n = 2; 2.2%), Salmonella (n = 2; 2.2%), and Enterobacter (n = 1; 1.1%) were among the other Enterobacterales isolated. Meropenem and imipenem were the most effective in isolates from Enterobacterales (n = 88) followed by amikacin (n = 84), ciprofloxacin (n = 75), and piperacillin-tazobactam (n = 70). Ceftriaxone and cefixime exhibited moderate susceptibility (n = 69 and 52) whereas, amoxicillin-clavulanate was the least susceptible (n = 3). We report high frequency of UTI in our pediatric population with uropathogens and associated antimicrobial susceptibility pattern confirming to the existing trends of pediatric UTIs in Pakistan. In addition to valuable insights for treating patients under similar conditions, our study serves as a catalyst for further multi-center research in this area.

Effect of Retrograde Autologous Priming on Coagulation Assessed by Rotation Thromboelastometry in Patients Undergoing Valvular Cardiac Surgery

ObjectivesTo investigate the effect of retrograde autologous priming (RAP) on coagulation function using rotation thromboelastometry (ROTEM) in patients undergoing valvular heart surgery. DesignProspective, randomized, patient- and outcome assessor-blinded study. SettingSingle-center university hospital. ParticipantsPatients aged 20 years or more undergoing valvular heart surgery. Interventions104 patients were allocated to the RAP or control group (1:1 ratio). In the RAP group, the prime was displaced into the collection bag before bypass initiation. ROTEM was performed at the induction of anesthesia, at the beginning of rewarming, and after the reversal of heparinization. Allogeneic plasma products and platelet concentrates were transfused according to ROTEM-based algorithms. Measurements and Main ResultsAn average volume of 635 ± 114 mL was removed using RAP (from the 1,600 mL initial prime volume). The hematocrit 10 min after CPB was 24.7 ± 3.5% in the control group and 26.1 ± 4.1% in the RAP group (P=0.330). ROTEM including EXTEM, INTEM, and FIBTEM showed prolonged clotting time and decreased maximal clot firmness after CPB in both groups, without intergroup differences. The number of patients who received intraoperative erythrocyte (27% vs. 25%, control vs. RAP, P=0.823), fresh frozen plasma (14% vs. 8%, control vs. RAP, P=0.339), cryoprecipitate (21% vs. 12%, control vs. RAP, P=0.185), or platelet concentrate transfusion (19% vs. 12%, control vs. RAP, P=0.277) did not differ between the groups. ConclusionsCPB induced impaired coagulation function on ROTEM. However, RAP did not improve coagulation function when compared with conventional priming in patients undergoing valvular heart surgery.

WITHDRAWN: Tranexamic acid to reduce postpartum blood loss after a vaginal delivery: a double-blinded, randomized controlled trial

To assess the effect of intravenous tranexamic acid (1 g) in reducing blood loss during the 3rd and 4th stages of labor following vaginal delivery, in addition to active management of the third stage of labor. This double-blinded randomized controlled trial included 650 women with singleton pregnancies of ≥ 34 weeks gestation undergoing vaginal delivery. Eligible women were randomly assigned to receive 1 g of tranexamic acid or placebo intravenously in addition to active management of the third stage of labor. Calibrated blood collection bags were used to measure postpartum blood loss during the 3rd and 4th stages of labor. Out of 886 expectant women who were approached, 650 instances that met the study's inclusion criteria were enrolled and a total of 320 women in group A and 321 in group B were analyzed. Maternal characteristics did not differ between the two groups. Mean blood loss did not differ significantly among the intervention and placebo groups (378.5±261.2 ml vs. 383±258.9 ml; p = 0.93). The incidence of primary postpartum hemorrhage was comparable in both groups (Group A: 15.9%, Group B: 15.3%, p = 0.814). The median fall in haemoglobin within 12-24 hours following delivery in both groups was comparable (group A: 0.60 g% with interquartile range (IQR) 0.4-0.9 g %; group B: 0.6 g% with IQR 0.4-0.8 g %; p = 0.95). The most common adverse effect reported was dizziness. No thromboembolic events were reported at the follow-up of three months in both groups. Prophylactic use of tranexamic acid in addition to active management of the third stage of labor does not help further reduce postpartum blood loss following vaginal delivery.

Development of an intentional rounding protocol for nursing undergraduates to apply in clinical practice

Purpose: This study aimed to develop an intentional rounding protocol to enhance the clinical competence of nursing students.Methods: An intentional rounding protocol for nursing students’ clinical practice was developed following the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) model. A convenient sampling method was used to select 23 junior year university nursing students during their clinical practice in adult nursing. The program evaluation included a quantitative assessment (communication and relationship efficacy, empathy, and patient safety competency) and focus group interviews.Results: The intentional rounding protocol focused on the 4Ps (pain, position, potty, and possessions) and encompassed aspects such as level of consciousness, pain management, personal care needs, intravenous injection, oxygen administration, nasogastric/nasoenteric tube care, maintenance of urine collection bags, and the identification of environmental fall risks. Nursing students performed intentional rounding at least twice a day. Following the implementation of this protocol, nursing students demonstrated a significant improvement in communication and interpersonal efficacy. The focus group interviews revealed four main themes: growth of human relationships, acquiring knowledge in and about the clinical field, becoming a nurse, and barriers in reality.Conclusion: The intentional rounding protocol has the potential to enhance nursing students’ communication and interpersonal skills during clinical practice and to provide them with positive experiences in nursing clinical education. Therefore, it is recommended that this protocol be incorporated into nursing clinical practice education.

Pre-Apheresis Prediction of CD34 + Cell Yield from Collecting Efficiency Is Not Reliable in Peripheral Blood Stem Cell Collection

Introduction Procurement of enough CD34 + cells (CD34 +) by apheresis is essential for the successful engraftment of peripheral blood stem cell transplantation (PBSCT). To determine the processed blood volume of apheresis to obtain a certain number of CD34 +, collecting efficiency 2 (CE2) is generally used, which is calculated from the total amount of CD34 + in the product (PBSC-CD34 +) divided by pre-apheresis CD34 + in the peripheral blood (PB-CD34 +) and by processed blood volume, and CE2 is determined beforehand from the accumulated data in each apheresis site. However, we sometimes experience cases in which collected amount of CD34 + are far from our expected values. It is probably because of the introduction of various CD34 + mobilization methods, new automated blood cell separators and protocols. Hence, we investigated thoroughly the kinetics of CD34 + in PBSC collection. Patients and Methods PBSC collections in 55 subjects, including 46 patients undergoing autologous PBSCT and 9 healthy allogeneic PBSCT donors, were analyzed prospectively. All patients were administered G-CSF 10 μg/day sc for 4 days and plerixafor 0.24 mg/kg sc at 22:30 on day 4, and PBSC collection was started from 9 am on day 5. Donors were given G-CSF 10 μg/day for 4 to 5 days until 2x10 6/kg (pt's body weight) CD34 + were collected. Apheresis was performed using Spectra Optia ® in CMNC mode. The apheresis time was adjusted depending on the CD34 + yield. CD34 + was analyzed by flow cytometry according to the ISHAGE protocol. Peripheral blood samples were obtained before, and every 1-1.5 hour after the start until the end of apheresis. Samples were also taken from the apheresis collection bag at the same timings as PB. Collecting efficiencies were calculated as follows: CE1(%) = [collected CD34 +]x100/([prePB-CD34 +]+[postPB-CD34 +])/2 x [processed blood volume]). CE0(%) = [collected CD34 +]x100/sum of ([prePB-CD34 +]+[postPB-CD34 +])/2 x [processed blood volume]) in each section (*CE0 was defined in this particular study). This study was conducted as a part of the prospective study, which was approved by the Ethics Committee of Keio University School of Medicine. Results More than 2x10 6/kg CD34 + were collected in the first day in 48 subjects (87%). The median processed blood volume and time was 5575 (range 3873-10903) mL and 185 (range 120-292) min, respectively. CE2 was calculated as a median 53% (range 20-88) from this cohort, but it varied markedly; CE2&amp;gt;70% in 6 cases, and &amp;lt;30% in 4. On the other hand, CE1 was median 65.5% (range 26.2-106.4%), and it also varied markedly; CE1&amp;gt;80% in 6 cases, and &amp;lt;40% in 7. CE1 and CE2 correlated strongly with each other (r=0.93), but CE1 was higher than CE2 in all cases but one; median 124(range 95-149) % (Fig.1). The main reason why CE1 was always higher than CE2 was probably because PB-CD34 + concentration was always declining during apheresis, which might be more influenced in plerixafor mobilization where CD34 + concentration changed in an hour-depending manner. In some apheresis cases with extremely low CE, it was revealed that cell aggregates containing myriads of platelets might have blocked the outlet of the collection kit, which was difficult to be recognized during apheresis. CE1 in each apheresis section also changed markedly during each apheresis and CE2 was not helpful for predicting optimal apheresis time (Fig. 2). In the first 10-20 minutes until the interphase formation, a real collection was not yet started so that CE1 in the first 1 hour became low. In the following sections, collection was supposed to become relatively steady, where CE would be influenced largely by interphase stability. In the last part of collection, CE tended to be relatively high for unknown reasons. CEs varied markedly during the whole collection periods. Conclusions Because multiple factors are associated with CE variability, CD34 + yields were sometimes far from the expected values calculated from prePB-CD34 + and CE2. Therefore, enumeration of CD34 + in the product during apheresis is recommended for secure and effective collections.