Use of Intravenous Albumin Callum, Jeannie; Skubas, Nikolaos J.; Bathla, Aarti ...
Chest,
3/2024
Journal Article
Recenzirano
Odprti dostop
Albumin is used commonly across a wide range of clinical settings to improve hemodynamics, to facilitate fluid removal, and to manage complications of cirrhosis. The International Collaboration for ...Transfusion Medicine Guidelines developed guidelines for the use of albumin in patients requiring critical care, undergoing cardiovascular surgery, undergoing kidney replacement therapy, or experiencing complications of cirrhosis.
Cochairs oversaw the guideline development process and the panel included researchers, clinicians, methodologists, and a patient representative. The evidence informing this guideline arises from a systematic review of randomized clinical trials and systematic reviews, in which multiple databases were searched (inception through November 23, 2022). The panel reviewed the data and formulated the guideline recommendations using Grading of Recommendations Assessment, Development and Evaluation methodology. The guidelines were revised after public consultation.
The panel made 14 recommendations on albumin use in adult critical care (three recommendations), pediatric critical care (one recommendation), neonatal critical care (two recommendations), cardiovascular surgery (two recommendations), kidney replacement therapy (one recommendation), and complications of cirrhosis (five recommendations). Of the 14 recommendations, two recommendations had moderate certainty of evidence, five recommendations had low certainty of evidence, and seven recommendations had very low certainty of evidence. Two of the 14 recommendations suggested conditional use of albumin for patients with cirrhosis undergoing large-volume paracentesis or with spontaneous bacterial peritonitis. Twelve of 14 recommendations did not suggest albumin use in a wide variety of clinical situations where albumin commonly is transfused.
Currently, few evidence-based indications support the routine use of albumin in clinical practice to improve patient outcomes. These guidelines provide clinicians with actionable recommendations on the use of albumin.
BACKGROUND
A safe and adequate supply of blood is critical to improving health care systems in sub‐Saharan Africa, where little is known about the current use of blood. The aim of this study was to ...comprehensively describe the use of blood at a tertiary care hospital to inform future efforts to strengthen blood programs in resource‐limited settings.
STUDY DESIGN AND METHODS
Data were collected from blood bank documentation for all units issued at Mulago Hospital Complex in Kampala, Uganda, from mid‐January to mid‐April 2014.
RESULTS
A total of 6330 units (69% whole blood, 32% red blood cells, 6% platelets, 2% plasma) were issued over the 3‐month study period to 3662 unique patients. Transfusion recipients were 58% female and median age was 27 years (interquartile range IQR, 14–41). Median pretransfusion hemoglobin was 5.6 g/dL (IQR, 4.0–7.2 g/dL, n = 1090). Strikingly, cancer was the top indication for transfusion (33.5%), followed by pregnancy‐related complications (12.4%) and sickle cell disease (6.9%).
CONCLUSION
This study provides a comprehensive picture of blood use at a national referral hospital in sub‐Saharan Africa. Noncommunicable diseases, particularly oncologic conditions, represent a large proportion of demand for transfusion services.
Many transfusion guidelines are available, but little appraisal of their quality has been undertaken. The quality of guidelines may potentially influence adoption. Our aim was to determine the ...quality of evidence-based transfusion guidelines (EBG) for red cells and plasma, using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument, and assess duplication and consistency of recommendations. MEDLINE and EMBASE were systematically searched for EBG from 2005 to June 3, 2016. Citations were reviewed for inclusion in duplicate. A guideline was included if it had a specified clinical question, described a systematic search strategy, included critical appraisal of the literature and a description of how recommendations were developed. Four to six physicians used AGREE II to appraise each guideline. Median and scaled scores were calculated, with each item scored on a scale of one to seven, seven representing the highest score. Of 6174 citations, 30 guidelines met inclusion criteria. Twenty six guidelines had recommendations for red cells and 18 included recommendations for plasma use. The median score, the scaled score and the interquartile range of the scaled score were: scope and purpose: median score 5, scaled score 60%, IQR (49–74%); stakeholder involvement 4, 43%, (33–49%); rigor of development 4, 41%, (19–59%); clarity of presentation 5, 69%, (52–81%); applicability 1, 16%, (9–23%); editorial independence 3, 43%, (20–58%). Sixteen guidelines were evaluated to have a scaled domain score of 50% or less. Variations in recommendations were found for the use of hemoglobin triggers for red cell transfusion in patients with acute coronary syndromes and for plasma use for patients with bleeding. Our findings document, limited rigor in guideline development and duplication and inconsistencies in recommendations for the same topic. The process of developing guidelines for red cells and plasma transfusion can be enhanced to improve implementation.
•30 evidence-based guidelines were reviewed using AGREE II.•This systematic review found limitations in guideline development.•The most common limitation was lack of implementation tools.
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Background. Hydroxyurea treatment is recommended for children with sickle cell anemia (SCA) living in high-resource malaria-free regions, but its safety and efficacy in malaria-endemic settings ...such as sub-Saharan Africa, where the greatest sickle cell burden exists, remain unknown. In vitro studies suggest hydroxyurea could increase malaria severity, through upregulation of intracellular adhesion molecule 1 (ICAM-1) that facilitates parasite adhesion to endothelium. In addition, hydroxyurea-associated neutropenia could worsen infections that occur in low-resource settings.
Methods. NOHARM (NCT01976416) was a randomized, double-blinded, placebo-controlled trial conducted in malaria-endemic Uganda. Children between the ages of 1.00-3.99 years were enrolled, and then received 12-months of blinded treatment with either hydroxyurea or placebo at 20 ± 2.5 mg/kg/day, with dose adjustments in both arms for weight gain and hematological toxicities. All participants received standard care for SCA including folic acid, penicillin prophylaxis, and pneumococcal vaccination. For malaria prophylaxis, children received insecticide-treated mosquito nets and monthly sulphadoxine-pyrimethamine. The primary outcome was incidence of clinical malaria. Secondary outcomes included SCA-related adverse events, clinical and laboratory effects, and hematological toxicities. After completing the blinded treatment phase, all participants were offered open-label hydroxyurea, as per local Ethics Committee recommendations.
Results. Study participants (median age 2.2 years) received either hydroxyurea (N=104) or placebo (N=103) for 12-months. Malaria occurred at a low rate throughout the study. The malaria incidence did not differ between children on hydroxyurea 0.05 episodes/child/year, 95% CI (0.02, 0.13) versus placebo 0.07 episodes/child/year (0.03, 0.16). The hydroxyurea/placebo malaria incidence rate ratio was 0.7 (0.2, 2.7), p=0.61, and time to infection did not differ significantly between treatment arms. A composite SCA-related clinical outcome (vaso-occlusive painful crisis, dactylitis, acute chest syndrome, splenic sequestration, or blood transfusion) was less frequent with hydroxyurea (45%) than placebo (69%, p=0.001). For individual clinical events, vaso-occlusive pain and hospitalizations were significantly less frequent with hydroxyurea than placebo; the number needed to treat to prevent one hospitalization was 6.4, while the number needed to treat to prevent a SCA-related event was 2.5. Serious adverse events, sepsis episodes, and dose-limiting toxicities were similar between treatment arms. Specifically, low hemoglobin (<6.0 g/dL) occurred more frequently in children receiving placebo than hydroxyurea, while the frequencies of neutropenia, thrombocytopenia and reticulocytopenia did not differ significantly between treatment arms. Three deaths occurred (two hydroxyurea, one placebo, none from malaria). Children receiving hydroxyurea had significantly increased hemoglobin concentration and fetal hemoglobin, along with decreased leukocytes, neutrophils, and reticulocytes.
Conclusions. In this prospective randomized double-blinded placebo-controlled trial of young children with SCA living in Uganda, hydroxyurea therapy was both safe and efficacious. Based on these NOHARM data, hydroxyurea treatment appears safe for children with SCA living in malaria-endemic sub-Saharan Africa, without increased risk for severe malaria, infections, or adverse events. Hydroxyurea provides predicted SCA-related laboratory and clinical efficacy, but the optimal dosing and monitoring regimens for affected children in Africa remain undefined.
Ware:Agios: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; Addmedica: Research Funding; Nova Laboratories: Consultancy; Global Blood Therapeutics: Consultancy.
Background and Objectives
In Caucasians, fetal/neonatal alloimmune thrombocytopenia (FNAIT) is most commonly due to maternal HPA‐1a antibodies. HPA‐1a typing followed by screening for anti‐HPA‐1a ...antibodies in HPA‐1bb women may identify first pregnancies at risk. Our goal was to review results from previous published studies to examine whether the maternal antibody level to HPA‐1a could be used to identify high‐risk pregnancies.
Materials and Methods
The studies included were categorized by recruitment strategies: screening of unselected pregnancies or samples analyzed from known or suspected FNAIT patients.
Results
Three prospective studies reported results from screening programmes, and 10 retrospective studies focused on suspected cases of FNAIT. In 8 studies samples for antibody measurement, performed by the monoclonal antibody immobilization of platelet antigen (MAIPA) assay, and samples for determining fetal/neonatal platelet count were collected simultaneously. In these 8 studies, the maternal antibody level correlated with the risk of severe thrombocytopenia. The prospective studies reported high negative predictive values (88–95%), which would allow for the use of maternal anti‐HPA‐1a antibody level as a predictive tool in a screening setting, in order to identify cases at low risk for FNAIT. However, due to low positive predictive values reported in prospective as well as retrospective studies (54–97%), the maternal antibody level is less suited for the final diagnosis and for guiding antenatal treatment.
Conclusion
HPA‐1a antibody level has the potential to predict the severity of FNAIT.
Background: A case control was carried out to study the prevalence, the pattern and associated factors of hearing loss among Ugandan children with sickle cell anaemia.
Methods: One hundred and ...thirty-two children known sickle cell and one hundred thirty aged matched non-SCA controls were recruited after medical ethics committee approval and informed consent. Two obtain information on socio-demographic characteristics, history, and examination of the participants, a structured questionnaire was administered. Pure tone audiometry (PTA) was used to assess the hearing in a sound-treated room.
Results: Twenty-two of the children had hearing impairment compared to 6 controls. Prevalence of hearing loss found among children with SCA was 17% but in the control group the prevalence found was 5%. Sensorineural hearing loss (SNHL) affected 39%, conductive (CHL) 25% and mixed (MHL) 14% among cases compared to CHL 7%, SNHL 7% and MHL 7% among the controls. The hearing loss varied from mild to moderate (95%). All sickle cell children had high-frequency hearing loss. There was a statistically significant association of hearing loss and neurologic motor deficit.
Conclusions: Sickle patients are at risk of developing hearing loss as the study demonstrated a difference in hearing threshold in children living with sickle cell anaemia and the controls. High frequencies were more affected. The neurologic motor deficit was highly associated with hearing loss among patients with SCA compared to controls.
Abstract Patients with hypoproliferative thrombocytopenia are at an increased risk for hemorrhage and alloimmunization to platelets. Updated guidance for optimizing platelet transfusion therapy is ...needed as data from recent pivotal trials have the potential to change practice. This guideline, developed by a large international panel using a systematic search strategy and standardized methods to develop recommendations, incorporates recent trials not available when previous guidelines were developed. We found that prophylactic platelet transfusion for platelet counts less than or equal to 10 × 109 /L is the optimal approach to decrease the risk of hemorrhage for patients requiring chemotherapy or undergoing allogeneic or autologous transplantation. A low dose of platelets (1.41 × 1011 /m2 ) is hemostatically as effective as higher dose of platelets but requires more frequent platelet transfusions suggesting that low-dose platelets may be used in hospitalized patients. For outpatients, a median dose (2.4 × 1011 /m2 ) may be more cost-effective to prevent clinic visits only to receive a transfusion. In terms of platelet products, whole blood–derived platelet concentrates can be used interchangeably with apheresis platelets, and ABO-compatible platelet should be given to improve platelet increments and decrease the rate of refractoriness to platelet transfusion. For RhD-negative female children or women of child-bearing potential who have received RhD-positive platelets, Rh immunoglobulin should probably be given to prevent immunization to the RhD antigen. Providing platelet support for the alloimmunized refractory patients with ABO-matched and HLA-selected or crossmatched products is of some benefit, yet the degree of benefit needs to be assessed in the era of leukoreduction.
Abstract Sub-Saharan Africa (SSA) is burdened with a growing population and poor health care resources. Transfusion medicine is uniquely affected for SSA as a result of a combination of factors which ...put tremendous pressure on the blood supply. In this review, we consider these factors including: malaria, sickle cell anemia, transfusion medicine infrastructure, and past transfusion medicine policies including those which are tied to foreign aid, such as a VNRD-only practice. We also consider how SSA can overcome some of these hurdles to achieve a safe and adequate blood supply for its people through the advent of new vaccines, medications, infrastructure development, policy changes, and education.
BACKGROUND: Previous surveys have reported variation in transfusion practice or policies in specific pediatric populations. Our objective was to determine the current transfusion policies in US and ...Canadian children's hospitals for both neonatal and pediatric general populations.
STUDY DESIGN AND METHODS: US and Canadian blood bank (BB) personnel at children's hospitals that provide blood products between the dates of October 2008 and January 2009 were surveyed.
RESULTS: Of the 90 US and Canadian children's hospitals identified, 51 (56.7%) blood bankers or their designees responded. There were 42 of 51 (82.4%) respondents from the United States and 9 of 51 (17.6%) from Canada. There was wide variation in beliefs regarding the effect of red blood cell (RBC) storage age on outcomes with 66.6% of respondents interested in a prospective randomized trial in critically ill children. There was also wide variation in policies restricting the storage age of RBCs according to patient age and clinical condition. In the United States 28 of 33 (84.8%) respondents provide universal leukoreduction of RBCs whereas it is 9 of 9 (100%) in Canada. Variation of policies existed for RBC irradiation and washing. The majority of respondents indicated that RBC transfusions were audited if the pretransfusion hemoglobin level was more than 8 to 10 mg/dL. Fresh whole blood is available at 6 of 40 (15%) responding children's hospitals.
CONCLUSIONS: There is a wide variation in BB policies regarding RBC transfusions at children's hospitals in the United States and Canada. Prospective randomized controlled trials are needed to allow for evidence‐based standards of care regarding RBC transfusions.
Sickle Cell Anemia (SCA) is highly prevalent in sub-Saharan Africa (SSA). In Uganda, approximately 20,000 children are born with SCA annually (Ndeezi G, 2016). Sickle brain vasculopathy causes both ...overt strokes and clinically “silent infarcts,” affecting neurological and cognitive function (DeBaun MR, 2012). Incidence of strokes has markedly decreased through standardized preventative measures. Study objectives are to determine the age-related spectrum and burden of brain injury associated with SCA in Ugandan children, determine predisposing risk factors and build capacity to support interventions for stroke prevention. Here we present preliminary results.
Methods: BRAIN SAFE is a cross-sectional study of a random sample of 250 children with SCA, ages 1-12 years, who receive care at the Mulago Hospital SCD clinic in Kampala.Potential participants were randomly selected from the clinic roster. Study exclusion criteria: hemoglobinopathy other than HbSS or HbS B0 thalassemia, age >12, acute illness, Hb <6.0gm/dl, recent transfusion, participation in another clinical study.
Stroke history and examination: were performed using the pediatric NIH Stroke Scale. Psychometric testing: Age-appropriate KABC-II, TOVA, BRIEF and Mullen testing were performed by skilled testers using validated versions in English or the predominant local language.
Transcranial doppler ultrasounds (TCDs) were performed (with good inter-operator reliability) by two study staff, both health professionals. They had been trained by a U.S.-based “STOP” trial TCD research nurse and a co-investigator who had TCD training in the U.S. The latter also performed standardized readings (Adams RJ, 1998). Quality assurance for TCD readings was provided by an independent stroke neurologist.
Brain Magnetic imaging (MRI/MRA): Using a single 1.5T scanner, a subset of subjects enriched for a history of stroke, abnormal neurological exam and/or cognitive testing. Two radiologists performed clinical reads. An independent neuroradiologist assessed sickle vasculopathy, per “SWiTCH” protocol (Helton KJ, 2014), blinded to clinical and radiological data.
Primary and secondary stroke prevention : Subjects with persistently non-normal TCDs on repeat testing or vasculopathy on MRI/MRAswill be offered hydroxyurea .
Results: Of the 248 participants screened in the 1st funding year, 233 were enrolled (mean age 5.62 years (range 1-12). Study exclusions due to age >12, acute illness, severe anemia, recent transfusion or participation in another study.
History and neurological exam : Overall, 7 of 233 had history consistent with a stroke, and an abnormal neurological exam, 5 had a history consistent with stroke but a normal neurological exam, 6 had abnormal neurological findings but no history of stroke (total abnormal 18/233, 7.7%).
Psychometrics : To date, cognitive test data results have been performed on 80 children; 30 (37.5%) were impaired with varying severity. (Full reports to follow.)
TCDs : A total of 224 non-imaging TCDs have been performed. Using standard criteria, 190 were normal, 4 abnormal (1.8%), and 30 conditional (13.4%). Repeat TCDs have been performed on 13 of those with non-normal reads and so far, 2 were abnormal, 6 conditional, 4 normal,1 had difficult windows.
MRI/MRAs: A subset of 29 subjects were selected with more clinical and/or historical stroke pathology (N= 25, 86%) and have undergone MR imaging to date (see Table). Mean age was 7.1 years (range 3-12); male: 55%. Of 26 with clinical radiological reads, 16 / 26 (61.5%) were abnormal. To date, scans from 12 subjects have had SCD vascular reads: 2 had no vasculopathy; 10 were abnormal: 6 with infarcts and arterial stenoses, 3 with infarcts only, 1 with bilateral stenoses only.
Conclusions: BRAIN SAFE, a Kampala-based cross-sectional study, has already enrolled and completed a large proportion of study procedures. Considerable brain pathology has been identified in all aspects tested, with high prevalence of abnormal history or physical findings, abnormal psychometrics, abnormal cerebral blood flow and/or brain MR imaging. Completion of enrollment and testing for the target sample will provide baseline data for longitudinal assessment and intervention. Building research capacity for faculty and trainees is ongoing.
Acknowledgments: 1R21HD089791 (PIs: Idro, Green) and Latanya Bowman, RN, Augusta University Sickle Cell Center.
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No relevant conflicts of interest to declare.
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