Chronic lymphocytic leukemia (CLL) is a disease of elderly patients. The fludarabine, cyclophosphamide, and rituximab (FCR) regimen is considered the treatment of choice for young fit patients with ...CLL; however, this combination is toxic for older patients. At the time this study was first planned and initiated, there was no standard chemo-immunotherapy regimen regarded as standard therapy for the less fit elderly patient with CLL. Here, we conducted a single-arm, phase II trial to examine the efficacy and safety of lower-dose fludarabine and cyclophosphamide combined with a standard dose of rituximab (LD-FCR) in elderly patients with previously untreated CLL. Forty patients received LD-FCR and were included in the efficacy analysis. Two patients treated with FC alone were only included in the safety analysis. The median age was 72.7 years (range, 65.0 to 85.0). The overall response and complete response rates were 67.5% and 42.5%, respectively. Median progression-free survival (PFS) was 35.5 months (95% CI, 29.27-41.67). Two patients (4.8%) died during the study period. Hematological toxicities and infections were the most common complications encountered; grade 3 to 4 treatment-related neutropenia occurred in 20 (47.6%) patients. During the entire study follow-up, 26 patients (61.9%) had all grades of infection including six (14.3%) with neutropenic fever and eight (19%) with grade 3 to 4 non-neutropenic infections. In conclusion, LD-FCR is an effective and relatively safe regimen for previously untreated patients with CLL. It has the advantage of being both "time and cost limited" and, even in the era of novel agents, can still be considered when planning treatment for elderly patients without high-risk biomarkers. However, recent results in fit elderly patients using the combination of bendamustine and rituximab which have achieved longer PFS with good safety profile must be taken into consideration in this regard.
Decreased absolute lymphocyte counts (ALCs) following frontline therapy for chronic lymphocytic leukemia may be associated with disease control, even in patients without evidence of minimal residual ...disease. We studied the prognostic significance of ALCs during the first year following treatment with fludarabine, cyclophosphamide, and rituximab (FCR). We evaluated 99 patients who achieved a partial response without lymphocytosis (<4.0 × 10
cells/μL) or better after FCR. Absolute lymphocyte counts were recorded at 3-, 6-, 9-, and 12-month posttreatment and correlated with overall survival (OS) and event-free survival (EFS). For each time point, analyses were limited to patients without lymphocytosis, so as to avoid possible biases from undocumented disease progressions. Lymphopenia (ALC < 1.0 × 10
cells/μL) at 3 m after FCR (69% of patients n = 68), was associated with a longer OS (5y OS 91% vs 64%, P = .001), as were ALC ≤ 2 × 10
cells/μL at 6 m (5y OS 85% vs 48%, P = .004) and ALC ≤ 1.8 × 10
cells/μL at 9 m (5y OS 93% vs 54%, P = .009). A normal-range ALC (≤4 × 10
cells/μL) at 12 m was also associated with a 91% 5y OS. Higher ALCs (but without lymphocytosis) were associated with shorter EFS (median EFS 27 months for ALC > 1.8 vs not reached for ALC ≤ 0.7 at 9 months, P < .0001). In conclusion, lower ALC levels in the first few months following frontline FCR therapy were associated with longer OS and EFS. Possible explanations may be that lower ALCs reflect deeper clonal suppression or protracted T
depletion. Absolute lymphocyte count levels may be a cheap and widely available prognostic marker, though the added value for clinical practice is the minimal residual disease era needs to be explored.
Objective
To assess the effects of tranexamic acid (TA) on hematological, hemostatic, and thromboelastographic analytes in healthy adult dogs.
Design
Prospective study.
Setting
University teaching ...hospital.
Animals
Eleven healthy, staff‐owned, adult dogs.
Measurements and Main Results
Dogs were administered TA as an IV bolus, followed by a 3‐hour constant rate infusion (CRI). Complete blood count, prothrombin time, activated partial thromboplastin time, D‐dimer, antithrombin, fibrinogen, and thromboelastography (TEG) were measured prior to, and immediately after TA administration. Vomiting occurred transiently in the first 2 treated dogs, immediately after 20 and 15 mg/kg IV boluses, but not during the CRI. In all other dogs the TA IV bolus dose was reduced to 10 mg/kg, and administered slower, and vomiting did not occur. All measured hemostatic and hematological analytes remained within their reference intervals, however, following TA treatment, significant decreases were recorded in prothrombin time, TEG R and A30 values, Hct, and hemoglobin concentration, while the TEG LY30 significantly increased.
Conclusions
Administration of TA as a slow IV bolus at 10 mg/kg, followed by a 10 mg/kg/h CRI over 3 hours to healthy dogs is safe; however, its effect on TEG A30, A60, LY30, and LY60 values was inconsistent with its expected anti‐fibrinolytic properties.
E-learning programmes are increasingly offered in transfusion medicine (TM) education. The aim of this study was to explore facilitators and barriers to TM e-learning programmes, including assessment ...of learning outcomes and measures of effectiveness.
Participants selected from a prior survey and representing a diverse number of international e-learning programmes were invited to participate. A mixed methodology was employed, combining a survey and individual semi-structured one-on-one interviews. Interview data were analysed inductively to explore programme development, evaluation, and facilitators and barriers to implementation.
Fourteen participants representing 13 institutions participated in the survey and 10 were interviewed. The e-learning programmes have been in use for a variable duration between 5 and 16 years. Funding sources varied, including government and institutional support. Learner assessment methods varied and encompassed multiple-choice-questions (n = 12), direct observation (n = 4) and competency assessment (n = 4). Most regional and national blood collection agencies rely on user feedback and short-term learning assessments to evaluate their programmes. Only one respondent indicated an attempt to correlate e-learning with clinical practices. Factors that facilitated programme implementation included support from management and external audits to ensure compliance with regulatory educational and training requirements. Barriers to programme implementation included the allocation of staff time for in-house development, enforcing compliance, keeping educational content up-to-date and gaining access to outcome data for educational providers.
There is evidence of considerable diversity in the evaluation of e-learning programmes. Further work is needed to understand the ultimate impact of TM e-learning on transfusion practices and patient outcomes.
Several options to treat hospitalized severe COVID-19 patients have been suggested. The study aimed to describe survival in patients treated with convalescent COVID plasma (CCP) and to identify ...in-hospital mortality predictors. This prospective cohort study examined data from 112 severe COVID-19 patients hospitalized in the Corona Departments in an acute care hospital who received two units of CCP (at least one of them high-titer). Demographic and medical data was retrieved from the patients’ electronic health records (EHR). Possible predictors for in-hospital mortality were analyzed in a univariate analysis and those found to be clinically significant were further analyzed in a multivariable analysis. Median age was 67 years (IQR 55–74) and 66 (58.9%) of them were males. Of them, 20 (17.9%) died in hospital. On multivariable analysis diabetes mellitus (p = 0.004, OR 91.54), mechanical ventilation (p = 0.001, OR 59.07) and lower albumin levels at treatment (p = 0.027, OR 0.74) were significantly associated with increased in-hospital mortality. In our study, in-hospital mortality in patients receiving CCP is similar to that reported for the general population, however certain variables mentioned above were associated with increased in-hospital mortality. In the literature, these variables were also associated with a worse outcome in patients with COVID-19 who did not receive CCP. As evidence points toward a benefit from CCP treatment in immunocompromised patients, we believe the above risk factors can further define COVID-19 patients at increased risk for mortality, enabling the selection of candidates for early treatment in an outpatient setting if possible.
Objectives
This survey aims to assess the scope of transfusion e‐learning courses in blood establishments and transfusion services internationally.
Background
E‐learning/online education is ...increasingly used in the education of medical professionals. There is limited published data on the use of e‐learning for transfusion medicine.
Material and Methods
An International survey was designed and distributed to all members of the International Society of Blood Transfusion to assess utilisation of e‐learning in their institutions. Descriptive statistics were used to summarise the results.
Results
A total of 177 respondents participated, 68 of which had e‐learning modules in their institutions. Approximately two‐thirds of the courses were developed in‐house (66%), and 63% are available to learners from outside the host institutions. In one‐third of institutions, these courses were established during the COVID‐19 pandemic, while 15% had used e‐learning courses for more than 10 years.
The courses target different audiences and topics ranging from blood donation to hemovigilance. The most common audiences were physicians (71%), laboratory scientists/technologists (69%) and transfusion practitioners (63%). Formal assessment of learning outcomes is used in 70% of the programs.
Conclusions
The survey demonstrates the widespread use of e‐learning courses in transfusion education, with a substantial proportion being developed during the COVID‐19 pandemic.
Transfusion guidelines advocate restrictive rather than liberal use of red blood cells (RBC) and are based mostly on randomized trials in intensive care and surgical departments. We aimed to study ...RBC transfusion practice in the medical patients' population.
The data in this study were collected from patients over the age of 18 years admitted to an Internal Medicine department between 2009 and 2014 who received at least one unit of packed red blood cells (RBC). In addition, data on demographics, patients' diagnoses, laboratory tests and number of transfused RBC units were extracted from the electronic health records.
One thousand three hundred and twenty eight patients were included, having mean age of 75 ± 14 years. The median hemoglobin (Hb) trigger for RBC transfusion was 8.0 g/dl (IQR 7.3-8.7g/dl), and most patients received either one (43.4%) or two (33.4%) RBC units. There was no significant difference in Hb trigger between males and females (Hb 8.0 g/dl and 7.9 g/dl, respectively, p = 0.098), and a weak correlation with age (r = 0.108 p = 0.001). Patients with cardiovascular and lung diseases had a statistically significant higher Hb trigger compared to patients without those diagnoses, however the median difference between them was 0.5 g/dl or less.
These "real world" data we collected show a Hb trigger compliant with the upper limit of published guidelines and influenced by medical patients' common diagnoses. Prospective trials addressing patients hospitalized in internal medicine departments could further contribute to transfusion decision algorithms.
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