Search Results (18)

Background: PP-007 (SANGUINATE^®, PEGylated carboxyhemoglobin, bovine) is under development to treat conditions of ischemia/hypoxia. Hemorrhagic/hypovolemic shock (H/HVS) becomes a life-threatening comorbidity due in part to hypotension and hypoxia. Blood transfusions are indicated, but supply and compatibility issues may limit subject access or when blood is not an option due to religious restriction or concern for clinical complications. PP-007 is universally compatible with an effective hydrodynamic radius and colloidal osmotic pressure facilitating perfusion without promoting extravasation. Methods: A review of previous clinical trials was performed and revealed an Open-Label Phase 1 safety study of acute severe anemia (hemoglobin ≤ 5 g/dL) in adult (≥18 y) patients unable to receive red blood cell transfusion (NCT02754999). Primary outcomes included safety events with secondary efficacy measures of organ function and survival at 1, 14, and 28 days. Additionally, a retrospective review of published, peer-reviewed case reports was performed, evaluating the administration of Sanguinate for Expanded Access in those patient populations where blood was not an option over the past 12 years. Results: A total of 103 subjects were enrolled in the Phase I safety study with significant co-morbidities that most commonly included hypertension (n = 43), acute and chronic kidney disease (n = 38), diabetes mellitus (n = 29), gastrointestinal bleeds (n = 18), and sickle cell disease (n = 13). Enrollment characteristics included decreased hemoglobin and severe anemia (mean baseline hemoglobin of 4.2 g/dL). Treatments included an average of three infusions [range 1–17]. Secondary efficacy measures were mean Hb levels, respiratory support, and vasopressor requirements, all demonstrating clinically relevant improvements. Fourteen additional cases were identified in the literature. Though one patient died due to pre-treatment conditions, all patients but one were discharged home in stable condition. Conclusion: Collectively, these observations are encouraging and provide support for the continued evaluation of PP-007 in advanced clinical trials in severe anemia including H/HVS. The review of published case reports underscored the potential of Sanguinate to reduce early mortality. Adverse effects included transient hypertension, lethargy, dizziness, and troponin elevation. These findings highlight the need for continued research and funding of blood alternatives to improve outcomes when standard blood transfusions are unavailable or contraindicated. Full article

Background and Objectives: This study aims to evaluate the adequacy of the liberal transfusion strategy applied in patients undergoing endoscopy-assisted Metopic, Coronal, or Sagittal craniosynostosis surgery according to the Pre-Transfusion and Post-Transfusion Estimated Red Blood Cell Mass (ERCM) ratios. Materials and Methods: This retrospective cohort study, conducted at the Pamukkale University Faculty of Medicine (2017–2023), utilized anesthesia, surgical records, and hospital electronic data of patients undergoing endoscopic craniosynostosis surgery. The primary endpoints were the rates of Post-Transfusion 1st-hour ERCM/Pre-Transfusion ERCM (%) and Post-Transfusion 24th-hour ERCM/Pre-Transfusion ERCM (%). The secondary endpoints were determined as Hemoglobin (Hb) and Hematocrit (Hct) values at the 1st and 24th hours after surgery, Calculated Blood Loss (CBL) during surgery (%), total 24 h CBL (%), ERCM (%), and Estimated Blood Loss (EBV) during surgery and total 24 h transfusions, Packed Red Blood Cells (PRBCs) (mL/kg) amounts during surgery, and total 24 h transfusions. Results: A total of 86 pediatric craniosynostosis cases were evaluated and categorized into Metopic (n = 38), Sagittal (n = 33), and Coronal (n = 15) groups, with Post-Transfusion evaluation conducted across these groups. Post-Transfusion 1st-hour ERCM/Pre-Transfusion ERCM ratios were found to have median values of 90.70% in the Metopic group, 91.61% in the Sagittal group, and 93.09% in the Coronal group. Post-Transfusion 24th-hour ERCM/Pre-Transfusion ERCM ratios were found to be median values of 94.05% in the Metopic group, 88.3% in the Sagittal group, and 87.08% in the Coronal group. Conclusions: The liberal transfusion strategy provided adequate transfusion, maintaining ERCM ratios within the 85–115% range across all groups. Significant decreases in Hb and Hct levels were observed from preoperative to postoperative measurements at 1 and 24 h. Changes in CBL, ERCM, EBV, and PRBC volumes were noted between the postoperative 1 h and 24 h measurements across all groups. Full article

Background/Objectives: Mastectomy is a surgical option for breast cancer when conservative treatment is unsuitable, and it is also performed prophylactically in high-risk women. Various surgical techniques can be used for mastectomy, including electrosurgery, which can cause thermal damage to tissues, reducing surgical precision and delaying wound healing. This study aims to compare electrical plasma surgery and hydrodissection, which appear to be the least traumatic methods, to determine the better option for performing mastectomy with immediate reconstruction. Methods: Conducted at the “Breast Unit” of AO “OrdineMauriziano Umberto I”, this study analyzed 56 patients undergoing 65 mastectomies (9 bilateral, 47 unilateral). A total of 16 were prophylactic, and 49 were oncologic. All patients received immediate subpectoral reconstruction. Data collected included preoperative medical history, pain, drain flow, blood transfusions, hemoglobin levels, and hospital stay duration. Complications were graded using the Clavien-Dindo classification. Results: Both groups were similar in age, body mass index (BMI), smoking habits, and comorbidities. Patients who underwent hydrodissection reported more pain on the first and second postoperative day and had longer hospital stays. The drop in hemoglobin from pre- to postoperative and the volume of surgical drains on the day of surgery and the first and second postoperative days were comparable between groups. Early complications and reintervention rates (Clavien-Dindo grade 3) were similar between techniques. Conclusions: Electrical plasma surgery offers better early postoperative outcomes in terms of pain and hospital stay, although overall complication and reintervention rates are unaffected by the technique used. Larger randomized studies are needed to confirm these findings and optimize patient management. Full article

Background: Intraoperative blood transfusion (IOBT) during liver transplantation (LT) has negative outcomes, and it has been shown that an increasing number of these procedures may no longer require IOBT. Regarding living donor liver transplantation (LDLT), the literature on the pre-transplant predictors of IOBT is quite heterogeneous and deficient. In this study, we reviewed our experience of IOBT among a homogenous cohort of adult right-lobe LDLTs. Methods: We conducted a retrospective analysis of prospectively collected data on adult LDLT recipients between January 2018 and October 2023. Two groups were constructed (No-IOBT vs. IOBT) for the exploration of pre- and intraoperative predictors of IOBT using univariate and multivariate analyses. An ROC curve analysis was applied to identify possible cut-offs. The one-year post-LDLT overall survival was compared using the Kaplan–Meier method. A p-value < 0.05 was considered statistically significant. Results: A total of 219 adult LDLT recipients were enrolled. The No-IOBT (n = 56) patients were mostly males (p = 0.016), with higher preoperative levels of HGB (p < 0.001), fibrinogen (p = 0.005), and albumin (p = 0.007) and a lower incidence of pre-transplant upper abdominal surgery (p = 0.017), portal vein thrombosis (p = 0.04), hepatorenal syndrome (p = 0.015), and ascites (p = 0.02) than the IOBT group (n = 163). The No-IOBT group had a shorter anhepatic phase (p = 0.002) and received fewer intravenous crystalloids (p = 0.001). In the multivariate analysis, the pre-transplant HGB (p < 0.001), fibrinogen (p < 0.001), and albumin (p = 0.04) levels were independent predictors of IOBT, showing the following cut-offs in the ROC curve analysis: HGB ≤ 11.5 (AUC: 0.800, p < 0.001), fibrinogen ≤ 125 (AUC: 0.638, p = 0.0024), and albumin ≤ 3.6 (AUC: 0.663, p = 0.0002). These were significantly associated with the No-IOBT group. The one-year overall survival of the No-IOBT and IOBT groups was 100% and 83%, respectively (p = 0.007). Conclusions: IOBT during LDLT is associated with inferior outcomes. The increased need of IOBT during LT can be predicted by evaluating serum levels of hemoglobin, albumin and fibrinogen before liver transplantation. Full article

Objectives: This multicenter, retrospective, population-based, matched-cohort study compared clinical characteristics and magnetic resonance imaging (MRI) findings, including hepatic, pancreatic, and cardiac iron levels and cardiac function, between 135 adult regularly transfused thalassemia intermedia (TI) patients (44.73 ± 12.16 years, 77 females) and 135 age- and sex-matched thalassemia major (TM) patients (43.35 ± 9.83 years, 77 females), enrolled in the Extension-Myocardial Iron Overload in Thalassemia Network. Methods: The MRI protocol included the quantification of hepatic, pancreatic, and cardiac iron levels (R2* technique), the assessment of biventricular function parameters (cine images), and the detection of replacement myocardial fibrosis (late gadolinium enhancement technique). Results: Age, sex, frequency of splenectomy and chelation, and serum ferritin levels were not significantly different (p > 0.05) between the two groups, but TI patients started regular transfusions significantly later (p < 0.0001) and showed significantly lower pre-transfusion hemoglobin levels (p = 0.005). No difference was found in hepatic iron levels (p = 0.853). TI patients exhibited significantly lower pancreatic R2* values (p < 0.0001), also correcting for the duration of regular transfusions, and significantly lower cardiac R2* values (p < 0.0001). In the receiver operating characteristic analysis, pancreatic iron was the strongest discriminator between the two diseases. Left and right ventricular end-diastolic volume indexes were significantly higher in TI than in TM patients (p = 0.003 and p = 0.046, respectively), but the correction for the duration of regular transfusions removed the disease-specific differences (p > 0.05). Left ventricular (LV) mass index was significantly higher in TI (p = 0.049), while no difference (p > 0.05) was found in biventricular ejection fractions and replacement myocardial fibrosis. Conclusions: TI patients showed lower pancreatic and cardiac iron burden and more pronounced LV hypertrophy. These differences could not be explained by the different duration of the transfusional regimen. Full article

Objectives: This study aimed to showcase how implementing a patient blood management (PBM) program effectively cuts unnecessary red blood cell (RBC) transfusions in a New York City urban community teaching hospital. Methods: Analyzing seven years from 2013 to 2019, a retrospective review of RBC transfusions was conducted. Results: Following the introduction of PBM, considerable improvements were observed annually. These included a drop in mean pretransfusion hemoglobin levels from 7.26 g/dL (2013) to 6.58 g/dL (2019), a 34% reduction in yearly RBC unit transfusions, and fewer units given to patients with pre-Hgb levels ≥ 7 g/dL (from 1210 units in 2013 to 310 units in 2019). Furthermore, this study noted a decline in two-unit RBC orders when Hgb levels were ≥ 7 g/dL from 65 orders in 2013 to merely 3 in 2019. The estimated total cost savings attributed to the six-year PBM program duration after full implementation in 2014 amounted to USD 2.1 million. Conclusions: Overall, PBM implementation significantly decreased RBC transfusions and enhanced transfusion practices. The findings emphasize that successful PBM strategies do not always necessitate extensive resources or increased budgets but instead rely on the application of intuitive methods, as evidenced by this study. Full article

Background and Objectives: The objective of this study was to assess the effectiveness of using a peri-cervical tourniquet in reducing blood loss during a laparoscopic myomectomy. Materials and Methods: This prospective study evaluated the impact of performing a concomitant tourniquet placement during a laparoscopic myomectomy (LM). A total of 60 patients were randomly allocated to one of two groups: 30 patients who underwent an LM with a tourniquet placement (the TLM group) and 30 patients who benefited from a standard LM (the SLM group). This study’s main objective was to evaluate the impact of tourniquet use on perioperative blood loss, which is quantified as the difference in the pre- and postoperative hemoglobin levels (Delta Hb) and the postoperative blood transfusion rate. Results: The mean Delta Hb was statistically lower in the TLM group compared to the SLM group: 1.38 g/dL vs. 2.41 g/dL (p < 0.001). The rate of postoperative iron perfusion in the TLM group was significantly lower compared to the SLM group (4 vs. 13 patients; p = 0.02). All four patients that required a blood transfusion were from the SLM group. On average, the peri-cervical tourniquet fastening time was 10.62 min (between 7 and 15 min), with no significant impact on the overall operative time: 98.50 min for the TLM group compared to 94.66 min for the SLM group. Conclusions: Fastening a tourniquet during a laparoscopic myomectomy is a valuable technique to effectively control intraoperative bleeding and enhance surgical outcomes. Full article

Due to the change in the structure of the proximal femur and acetabulum in patients with developmental dysplasia of the hip, total hip arthroplasty (THA) was difficult to perform for surgeons. To elevate the acetabular coverage rate, we developed a technique in the use of a patient-specific instrumentation (PSI) graft in patients with developmental dysplasia of hip (DDH) undergoing surgery. This study aims to evaluate the peri-operative outcomes of THA with PSI graft in patients with DDH. This study recruited 6 patients suffering from Crowe I DDH with secondary Grade IV osteoarthritis. All the patients underwent THA with PSI graft performed by a well-experienced surgeon. Perioperative outcomes included surgical procedures, blood loss during operation, the volume of blood transfusion, length of hospitalization, complications, and the mean difference in hemoglobin levels before and after surgery. All the outcomes analyzed were assessed by mean and standard deviation. The average duration of the surgical procedure was found to be 221.17 min, with an SD of 19.65 min. The mean blood loss during the operation was 733.33 mL, with an SD of 355.90 mL. The mean length of hospital stay was calculated to be 6 days, with an SD of 0.89 days. Furthermore, the mean difference between the pre- and postoperative hemoglobin levels was 2.15, with an SD of 0.99. A total of three patients received 2 units of leukocyte-poor red blood cells (LPR) as an accepted blood transfusion. There were no reported complications observed during the admission and one month after the operation. This study reported the peri-operative outcomes in the patients with DDH who underwent THA with PSI graft. We found that THA with PSI graft would provide a safe procedure without significant complications. We assumed that the PSI graft in THA may increase the coverage rate of the acetabulum, which may increase the graft union rates. Further cohort studies and randomized controlled trials were needed to confirm our findings. Full article

Background: Extracapsular femoral neck fractures (eFNF) are the third most common type of fracture in traumatology. Intramedullary nailing (IMN) is one of the most frequently used ortho-pedic treatments for eFNF. Blood loss is one of the main complications of this treatment. This study aimed to identify and evaluate the perioperative risk factors that lead to blood transfusion in frail patients with eFNF who undergo IMN. Methods: From July 2020 to December 2020, 170 eFNF-affected patients who were treated with IMN were enrolled and divided into two groups according to blood transfusion: NBT (71 patients who did not need a blood transfusion), and BT (72 patients who needed blood transfusion). Gender, age, BMI, pre-operative hemoglobin levels, in-ternational normalized ratio (INR) level, number of blood units transfused, length of hospital stay, surgery duration, type of anesthesia, pre-operative ASA score, Charlson Comorbidity Index, and mortality rate were assessed. Results: Cohorts differed only for pre-operatively Hb and surgery time (p < 0.05). Conclusion: Patients who have a lower preoperative Hb level and longer surgery time have a high blood-transfusion risk and should be closely followed peri-operatively. Full article

Transfusion-dependent thalassemia is the most severe form of thalassemia; patients require regular blood transfusions to maintain their hemoglobin level. The COVID-19 pandemic has disrupted the routine measures for controlling chronic diseases like thalassemia. This study aims to measure the difference in pre-transfusion hemoglobin levels and the frequency of transfusions before and during pandemic. This retrospective cross-sectional study utilized medical record data of 101 transfusion-dependent thalassemia (TDT) patients treated in Cipto Mangunkusumo Hospital (CMH) from 2019–2021. The dependent variables of this study were pre-transfusion hemoglobin level and transfusion attendance. The pre-pandemic phase was defined as 30 March 2019 to 29 March 2020, whereas the during-pandemic phase was from 30 March 2020 to 29 March 2021. Up to 59.4% of subjects had suboptimal Hb levels of <9.0 g/dL, even before the pandemic, and this increased to 71.3% during the pandemic. The mean pre-transfusion hemoglobin level before the pandemic was 8.71 g/dL, and this decreased to 8.46 g/dL (p value < 0.001). Transfusion attendance before and during the pandemic showed no significant difference (p-value = 0.990). Our study shows poorer control of pre-transfusion Hb levels during the pandemic. This puts patients at higher risk of developing many long-term complications. Full article

Background: Eligibility criteria for blood donation require hemoglobin levels of ≥12.5 g/dL for women and ≥13.5 g/dL for men, and a platelet count of ≥180 × 109/L. Screening methods before donation should ensure high accuracy, precision, and ease in operation. We assessed the performance, precision, and repeatability of the Horiba Micros ES 60 (Horiba) compared to the Beckman Coulter DXH 800. Methods: Performance was compared by testing samples for each of the 11 devices across 6 sites in the Transfusion Service of Friuli Venezia Giulia Region, Italy. We measured precision by calculating the coefficient of variation (CV), concordance with ρ-Pearson’s correlation coefficient, and accuracy with F-tests. The intra-assay agreement was examined in the 11 devices, and repeatability was performed by using CV and the Kruskal–Wallis test. Results: The precision of Horiba was acceptable. Overall, ρ-Pearson’s coefficients indicated a strong correlation and positive relationship between all variables. The Bland–Altman plots showed that most of the differences lay within the limits of agreement. All CV were below the reference threshold for all the parameters. Finally, the Kruskal–Wallis test reported non-significant statistical differences for all parameters, except platelet count (p < 0.000). Conclusions: Horiba is adequate for routine pre-donation screening. The intra-assay agreement further demonstrates the accuracy of the device. Full article

The aim of this study was to compare the estimated blood loss and the frequency of obstetric hemorrhage among pregnant women with and without COVID-19 infection. The study was carried out in the Department of Obstetrics and Gynecology, at the Central Clinical Hospital of the Ministry of the Interior and Administration in Warsaw, Poland. From 15 May 2020 to 26 April 2021, a total of 224 parturients with COVID-19 infection were admitted for labor. The control group consisted of 300 randomly recruited pre-pandemic deliveries that took place between 15 May 2019 and 26 April 2020 at the Department. The primary outcome was the presence of postpartum hemorrhage, defined as an estimated blood loss of ≥500 mL within 24 h after birth or the need to transfuse 2 or more units of packed red blood cells (pRBCs). Secondary outcomes were the difference between hemoglobin and hematocrit levels at 24 h postpartum, the number of pRBCs units transfused, and the need for transperitoneal drainage. After applying the propensity-score-matching procedure for postpartum bleeding risk factors, 325 eligible patients were included in the final analysis, divided into 203 COVID-19 positive and 122 COVID-19 negative prepandemic deliveries. SARS-CoV-2 infected patients were characterized by a longer activated partial thromboplastin time (APTT), a reduced prothrombin time (PT), and lower platelet count at initial presentation. COVID-19 deliveries were found to be associated with a higher frequency of postpartum hemorrhage, an increased estimated blood loss, the more frequent use of peritoneal drainage, and more pRBCs units transfused. During the pandemic, an increased risk of postpartum hemorrhage posed another threat to SARS-CoV-2 infected pregnant women. It is essential to be aware of this when approaching COVID-19 delivery and to implement efficient preventative methods. Full article

Patients with sickle cell anemia often receive multiple red blood cell (RBC) transfusions during their lifetime. Hyperhemolysis is a life-threatening phenomenon of accelerated hemolysis and worsening anemia that occurs when both transfused RBCs and autologous RBCs are destroyed. The level of hemoglobin post-transfusion is lower than pre-transfusion levels, and patients are usually hemodynamically unstable. Hyperhemolysis must be differentiated from a delayed hemolytic transfusion reaction during which destruction of transfused RBC is the cause of anemia. Hyperhemolysis syndrome can be differentiated into acute (within seven days) and chronic forms (after seven days) post-transfusion. The authors present a case of acute hyperhemolysis syndrome in a patient with sickle cell anemia refractory to steroids and IVIG, which are the treatment of choice. The patient was treated with tocilizumab, combined with supportive measures of erythropoietin, iron, vitamin B12, and folate. Full article

Background: We aimed to describe red blood cell (RBC) transfusions in the emergency department (ED) with a particular focus on the hemoglobin (Hb) level thresholds that are used in this setting. Methods: This was a cross-sectional study of 12 EDs including all adult patients that received RBC transfusion in January and February 2018. Descriptive statistics were reported. Logistic regression was performed to assess variables that were independently associated with a pre-transfusion Hb level ≥ 8 g/dL. Results: During the study period, 529 patients received RBC transfusion. The median age was 74 (59–85) years. The patients had a history of cancer or hematological disease in 185 (35.2%) cases. Acute bleeding was observed in the ED for 242 (44.7%) patients, among which 145 (59.9%) were gastrointestinal. Anemia was chronic in 191 (40.2%) cases, mostly due to vitamin or iron deficiency or to malignancy with transfusion support. Pre-transfusion Hb level was 6.9 (6.0–7.8) g/dL. The transfusion motive was not notified in the medical chart in 206 (38.9%) cases. In the multivariable logistic regression, variables that were associated with a higher pre-transfusion Hb level (≥8 g/dL) were a history of coronary artery disease (OR: 2.09; 95% CI: 1.29–3.41), the presence of acute bleeding (OR: 2.44; 95% CI: 1.53–3.94), and older age (OR: 1.02/year; 95% CI: 1.01–1.04). Conclusion: RBC transfusion in the ED was an everyday concern and involved patients with heterogeneous medical situations and severity. Pre-transfusion Hb level was rather restrictive. Almost half of transfusions were provided because of acute bleeding which was associated with a higher Hb threshold. Full article

Objectives: Our aim was to assess blood utilization after implementation of a patient blood management (PBM) program in a Greek tertiary hospital. Methods: An electronic transfusion request form and a prospective audit of transfusion practice were implemented. After the one-year implementation period, a retrospective review was performed to assess transfusion practice in medical patients. Results: Pre-PBM, a total of 9478 RBC units were transfused (mean: 1.75 units per patient) compared with 9289 transfused units (mean: 1.57 units per patient) post-PBM. Regarding the post-PBM period, the mean hemoglobin (Hb) level of the 3099 medical patients without comorbidities transfused was 7.19 ± 0.79 gr/dL. Among them, 2065 (66.6%) had Hb levels >7.0 gr/dL, while 167 (5.3%) had Hb levels >8.0 gr/dL. In addition, 331 (25.3%) of the transfused patients with comorbidities had Hb >8.0 gr/dL. The Hb transfusion thresholds significantly differed across the clinics (p < 0.001), while 21.8% of all medical non-bleeding patients received more than one RBC unit transfusion. Conclusion: A poor adherence with the restrictive transfusion threshold of 7.0 gr/dL was observed. The adoption of a less strict threshold might be a temporary step to allow physicians to become familiar with the program and be informed on the safety and advantages of the restrictive transfusion strategy. Full article