Transfusion Camp Rwanda: A prospective feasibility study evaluating the delivery of Transfusion Camp to a multidisciplinary group of postgraduate medical trainees in Rwanda.

BACKGROUND: Safe blood transfusion is an increasing priority in global health equity. The Global Health 2030 commission lists access to a safe blood supply as essential for all surgical and nonoperative patients. The objective of this study was to determine if Transfusion Camp, when modified through a collaborative partnership between experts in Canada and Rwanda, results in improved knowledge and confidence among trainees in a resource-limited setting in sub-Saharan Africa. METHODS: This prospective study took place at The University Teaching Hospital of Kigali in Rwanda. Participants were postgraduate medical trainees from departments where blood transfusion is frequent. Participants watched five prerecorded lectures and then attended a 5-hour team-based learning seminar to consolidate learning. Pre- and post-data were analyzed on transfusion knowledge and trainee confidence. A Rasch analysis investigated the performance of individual questions in assessing respondent knowledge. RESULTS: Of 31 trainees from surgery, anesthesia, internal medicine, and pediatrics invited to the course, 27 trainees attended the in-person team-based learning and 24 trainees completed the pre- and post-course analysis. Trainee knowledge assessment improved from (mean ± SD) 7.7/20 ± 1.95 to 10.4/20 ± 2.4 (p < .0001) and this knowledge was maintained by 12 trainees on a 3-month follow-up with a mean score of 9.3/20 ± 2.3. Trainees reported increased confidence in managing transfusion medicine-related patient issues. CONCLUSION: This pilot study demonstrated that Transfusion Camp education content modified to the local context can result in increased knowledge and confidence in managing transfusion-related issues. These results will inform future planning of Transfusion Camp in resource-limited settings.

Implementation of a blood bank generated tube for second blood group determination: Challenges, yield, and cost.

BACKGROUND: The second blood group determination or group check sample is a process of verifying the ABO group with a second blood sample prior to transfusion. It has been used to detect errors related to wrong blood in tube (WBIT) events and reduce the risk of ABO-incompatible transfusions. To prevent the clinical team from collecting the group check sample at the same time as the first sample, a tan top tube only available from the blood bank was introduced for second blood group determinations if drawn within 24 h of the first group and screen. STUDY DESIGN AND METHODS: This is a retrospective study analyzing data from 2005 to 2020 before and after the implementation of the blood bank supplied tan top tube for group check. The number of WBIT events, transfusion delays, and health care costs were determined. RESULTS: The number of WBIT events remained unchanged throughout the time period. No delays in transfusion or procedure were reported due to the tan top tube group check. There was no increase in group O transfusions over time. In comparison to using an ethylenediaminetetraacetic acid (EDTA) tube, the tan top tube was estimated to add an extra yearly cost of $790.79 Canadian dollars. CONCLUSION: Second blood group determination using the blood bank supplied tan top tube did not increase the number of WBIT events detected but ensured an independent sample draw. A minimal incremental cost of implementing the tan top tube was noted with no delay in transfusions or procedures.

Cost-effectiveness of eltrombopag vs intravenous immunoglobulin for the perioperative management of immune thrombocytopenia.

Eltrombopag has been shown to be noninferior to intravenous immunoglobulin (IVIG) for improving perioperative platelet counts in patients with immune thrombocytopenia (ITP) in a randomized trial; thus, cost is an important factor for treatment and policy decisions. We used patient-level data from the trial to conduct a cost-effectiveness analysis comparing perioperative eltrombopag 50 mg daily starting dose, with IVIG 1 or 2 g/kg (according to local practice) from a Canadian public health care payer's perspective over the observation period, from preoperative day 21 to postoperative day 28. Resource utilization data were obtained from the trial data (eltrombopag, n = 38; IVIG, n = 36), and unit costs were collected from the Ontario Schedule of Benefits, Ontario Drug Formulary, and secondary sources. All costs were adjusted to 2020 Canadian dollars. We calculated the incremental cost per patient for all patients randomized. Uncertainty was addressed using nonparametric bootstrapping. The use of perioperative eltrombopag for patients with ITP resulted in a cost-saving of $413 Canadian per patient. Compared with IVIG, the probability of eltrombopag being cost effective was 70% even with no willingness to pay. In a sensitivity analysis based on IVIG dose, we found that with the higher dose of IVIG (2 g/kg), eltrombopag saved $2,714 per patient, whereas with the lower dose of IVIG (1 g/kg), eltrombopag had a higher mean cost of $562 per patient. In summary, based on data from the randomized trial that demonstrated noninferiority, the use of eltrombopag for the management of ITP in the perioperative setting was less costly than IVIG.

The utility of a monocyte monolayer assay in the assessment of intravenous immunoglobulin-associated hemolysis.

BACKGROUND: Hemolysis following the administration of intravenous immunoglobulin (IVIG) is an important adverse event (AE). While the monocyte monolayer assay (MMA) has been used to predict in vivo hemolysis when serologically incompatible blood may be transfused, it has also been shown to correlate with IVIG-associated hemolysis. In this study, the MMA was examined for its utility in assessing the risk of hemolysis after IVIG. STUDY DESIGN AND METHODS: Forty-two non-blood group O patients receiving high-dose IVIG (≥2 g/kg) were examined using an autologous and allogeneic MMA. Hemolysis was defined by a drop in hemoglobin of ≥1 g/L, a positive direct antiglobulin test (DAT) and eluate, and a decrease in haptoglobin or increase in lactate dehydrogenase and/or reticulocytes. RESULTS: Forty-two patients provided 50 assessable postinfusion samples, with hemolysis observed in 20 (40%) of cases. Autologous MMA using post-IVIG red blood cells significantly correlated with clinical outcomes when compared to allogeneic MMA (P = .0320 vs .5806, t test). No significant difference in receiver operating characteristics was observed when comparing autologous MMA testing against DAT for the diagnosis of IVIG-associated hemolysis. However, when using samples collected 5 to 10 days after receipt of high-dose IVIG, the autologous MMA had higher sensitivity than the DAT. CONCLUSION: MMA testing with autologous monocytes collected 5 to 10 days after receipt of high-dose IVIG can be used for the diagnosis of IVIG-associated hemolysis and may be of particular value in cases in which the Day 5 to 10 DAT is negative.

Feeling the burn: the significant burden of febrile nonhemolytic transfusion reactions.

BACKGROUND: Febrile nonhemolytic transfusion reactions (FNHTRs) are characterized by a post-transfusion temperature rise (of ≥ 1°C, to ≥ 38°C) or chills/rigors unrelated to the underlying condition. FNHTRs are provoked by inflammatory cytokines in the product or by host antileukocyte antibodies against residual donor leukocytes. FNHTRs are among the most commonly reported transfusion disturbances and are generally deemed nonserious events. However, their impact on patients and hospitals may be underestimated. STUDY DESIGN AND METHODS: A search through two hemovigilance databases identified all known possible-to-definite FNHTRs over 3 years (2013-2015) at four academic hospitals using prestorage leukoreduced components. FNHTRs were assessed for frequency by product (red blood cells [RBCs], platelets [PLTs], intravenous immunoglobulin), diagnostics (bedside, chest imaging, serology, microbiology), and management (medications, disposition change). The definition of FNHTR was derived from Canada's Transfusion-Transmitted Injuries Surveillance System. RESULTS: For 437 FNHTRs, the overall per-product rate across all sites was 0.24%, or 0.17% with RBCs alone and 0.25% with PLTs alone. One-third of patients had significant fevers (≥ 39.0°C or a rise by ≥ 2.0°C). Approximately one-quarter underwent chest imaging within 48 hours, and 79% had blood cultures. A hospital admission directly attributable to the FNHTR, to exclude other causes of fever, occurred in 15% of FNHTR outpatients. CONCLUSION: An analysis of FNHTRs reveals a substantial burden of postreaction clinical activity in addition to the disturbance itself. Efforts to avoid this adverse event may save resources, reduce patient distress, and encourage compliance with more restrictive transfusion strategies.

A decision model and cost analysis of intra-operative cell salvage during hepatic resection.

BACKGROUND: Intraoperative cell salvage (ICS) can reduce allogeneic transfusions but with notable direct costs. This study assessed whether routine use of ICS is cost minimizing in hepatectomy and defines a subpopulation of patients where ICS is most cost minimizing based on patient transfusion risk. METHODS: A decision model from a health systems perspective was developed to examine adoption and non-adoption of ICS use for hepatectomy. A prospectively maintained database of hepatectomy patients provided data to populate the model. Probabilistic sensitivity analysis was used to determine the probability of ICS being cost-minimizing at specified transfusion risks. One-way sensitivity analysis was used to identify factors most relevant to institutions considering adoption of ICS for hepatectomies. RESULTS: In the base case analysis (transfusion risk of 28.8%) the probability that routine utilization of ICS is cost-minimizing is 64%. The probability that ICS is cost-minimizing exceeds 50% if the patient transfusion risk exceeds 25%. The model was most sensitive to patient transfusion risk, variation in costs of allogeneic blood, and number of appropriate cases the device could be used for. CONCLUSIONS: ICS is cost-minimizing for routine use in liver resection, particularly when used for patients with a risk of transfusion of 25% or greater.

BEST-TEST2: assessment of hematology trainee knowledge of transfusion medicine.

BACKGROUND: As transfusion is a common therapy and key component in every hematologist's practice, hematology training programs should dedicate significant time and effort to delivering high-quality transfusion medicine education to their trainees. The current state of hematology trainee knowledge of transfusion medicine is not known. STUDY DESIGN AND METHODS: A validated assessment tool developed by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative was used to assess prior transfusion medicine education, attitudes, perceived ability, and transfusion medicine knowledge of hematology trainees. RESULTS: A total of 149 hematology trainees at 17 international sites were assessed. The overall mean exam score was 61.6% (standard deviation, 13.4%; range, 30%-100%) with no correlation in exam scores with postgraduate year or previous transfusion medicine education in medical school or internal medicine residency. However, better scores correlated with 3 or more hours of transfusion medicine education (p = 0.0003) and perceived higher-quality education during hematology training (p = 0.03). Hematology trainees at US sites, where hematology is often combined with oncology training, had statistically lower scores than trainees at non-US sites (56.2% vs. 67.4%; p < 0.0001). In terms of topic areas, although 93% of participants had obtained consent for transfusion, the lowest scores were on transfusion reaction-related questions. CONCLUSION: Given the overall poor performance, this study serves as an impetus for all hematology training programs to reevaluate the quality and quantity of transfusion medicine training and can assist in the development of targeted curricula.

Internal medicine resident knowledge of transfusion medicine: results from the BEST-TEST international education needs assessment.

BACKGROUND: Blood transfusion is the most common hospital procedure performed in the United States. While inadequate physician transfusion medicine knowledge may lead to inappropriate practice, such an educational deficit has not been investigated on an international scale using a validated assessment tool. Identifying specific deficiencies is critical for developing curricula to improve patient care. STUDY DESIGN AND METHODS: Rasch analysis, a method used in high-stakes testing, was used to validate an assessment tool consisting of a 23-question survey and a 20-question examination. The assessment tool was administered to internal medicine residents to determine prior training, attitudes, perceived ability, and actual knowledge related to transfusion medicine. RESULTS: A total of 474 residents at 23 programs in nine countries completed the examination. The overall mean score of correct responses was 45.7% (site range, 32%-56%). The mean score for Postgraduate Year (PGY)1 (43.9%) was significantly lower than for PGY3 (47.1%) and PGY4 (50.6%) residents. Although 89% of residents had participated in obtaining informed consent from a patient for transfusion, residents scored poorly (<25% correct) on questions related to transfusion reactions. The majority of residents (65%) would find additional transfusion medicine training "very" or "extremely" helpful. CONCLUSION: Internationally, internal medicine residents have poor transfusion medicine knowledge and would welcome additional training. The especially limited knowledge of transfusion reactions suggests an initial area for focused training. This study not only represents the largest international assessment of transfusion medicine knowledge, but also serves as a model for rigorous, collaborative research in medical education.

Evaluating the 4-hour and 30-minute rules: effects of room temperature exposure on red blood cell quality and bacterial growth.

BACKGROUND: A 30-minute rule was established to limit red blood cell (RBC) exposure to uncontrolled temperatures during storage and transportation. Also, RBC units issued for transfusion should not remain at room temperature (RT) for more than 4 hours (4-hour rule). This study was aimed at determining if single or multiple RT exposures affect RBC quality and/or promote bacterial growth. STUDY DESIGN AND METHODS: Growth and RT exposure experiments were performed in RBCs inoculated with Serratia liquefaciens and Serratia marcescens. RBCs were exposed once to RT for 5 hours (S. liquefaciens) or five times to RT for 30 minutes (S. marcescens) with periodic sampling for bacterial counts. Noncontaminated units were exposed to RT once (5 hr) or five times (30 min each) and sampled to measure in vitro quality variables. RBC core temperature was monitored using mock units with temperature loggers. Growth and RT exposure experiments were repeated three and at least six times, respectively. Statistical analysis was done using mixed-model analysis. RESULTS: RBC core temperature ranged from 7.3 to 11.6°C during 30-minute RT exposures and the time to reach 10°C varied from 22 to 55 minutes during 5-hour RT exposures. RBC quality was preserved after single or multiple RT exposures. Increased growth of S. liquefaciens was only observed after 2 hours of continuous RT exposure. S. marcescens concentration increased significantly in multiple-exposed units compared to the controls but did not reach clinically important levels. CONCLUSION: Single or multiple RT exposures did not affect RBC quality but slightly promoted bacterial growth in contaminated units. The clinical significance of these results remains unclear and needs further investigation.

A systematic assessment of the quality of reporting for platelet transfusion studies.

BACKGROUND: As evidence-based medicine assumes increasing importance, there is a need for high-quality reporting of clinical studies. A recent review of clinical platelet (PLT) studies indicated variability in reporting. We undertook a critical analysis of PLT transfusion studies to determine the quality of reporting. STUDY DESIGN AND METHODS: A systematic MEDLINE search for clinical studies of PLT transfusion was performed to identify articles. Relevant observational studies (OBS) were critiqued using the STROBE checklist and randomized controlled clinical trials (RCTs) using the CONSORT checklist. Studies were further evaluated with a PLT-specific checklist developed by the authors. Observations were analyzed descriptively and using Pareto analysis. RESULTS: A total of 772 articles were identified by the search. Eighty-six articles (23 RCTs and 63 OBS) met eligibility criteria. All RCTs, and a similar number of OBS (24), were randomly selected for analysis. Studies reported the scientific background and rationale, key results, and outcomes. OBS frequently did not consider bias and confounders. RCTs frequently did not explain bias, interim analyses, stopping rules, success of blinding, or weaknesses of multiple analyses. The PLT-specific critique found many studies adequately reported basics of the PLT product, PLT increment, and transfusion reactions. Studies frequently failed to report specific details of PLT compatibility, details of product preparation, and use of other blood products. CONCLUSION: Recently published articles of clinical PLT transfusion share common strengths and weaknesses. The quality of reporting may be improved by providing guidelines to authors and journal editors that list the essential elements of a well-reported clinical study of PLT transfusion.

Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies.

Significant progress has been made in reducing the risk of pathogen transmission to transfusion recipients. Nonetheless, there remains a continuing risk of transmission of viruses, bacteria, protozoa, and prions to recipients. These include many of the viruses for which specific screening tests exist as well as pathogens for which testing is currently not being done, including various species of bacteria, babesiosis, variant Creutzfeld-Jacob disease, hepatitis A virus, human herpes virus 8, chikungunya virus, Chagas disease, and malaria. Pathogen inactivation (PI) technologies potentially provide an additional way to protect the blood supply from emerging agents and also provide additional protection against both known and as-yet-unidentified agents. However, the impact of PI on product quality and recipient safety remains to be determined. The purpose of this consensus conference was to bring together international experts in an effort to consider the following issues with respect to PI: implementation criteria; licensing requirements; blood service and clinical issues; risk management issues; cost-benefit impact; and research requirements. These proceedings are provided to make available to the transfusion medicine community the considerable amount of important information presented at this consensus conference.