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Bioanalysis Nov 2023Alternatives to phlebotomy in clinical trials increase options for patients and clinicians by simplifying and increasing accessibility to clinical trials. The...
Alternatives to phlebotomy in clinical trials increase options for patients and clinicians by simplifying and increasing accessibility to clinical trials. The authors investigated the technical and logistical considerations of one technology compared with phlebotomy. Paired samples were collected from 16 donors via a second-generation serum gel microsampling device and conventional phlebotomy. Microsamples were subject to alternative sample handling conditions and were evaluated for quality, clinical testing and proteome profiling. Timely centrifugation of blood serum microsamples largely preserved analyte stability. Centrifugation timing of serum microsamples impacts the quality of specific clinical chemistry and protein biomarkers. Microsampling devices with remote centrifugation and refrigerated shipping can decrease patient burden, expand clinical trial populations and aid clinical decisions.
Topics: Humans; Blood Specimen Collection; Serum; Clinical Trials as Topic; Phlebotomy; Dried Blood Spot Testing; Technology
PubMed: 37855231
DOI: 10.4155/bio-2023-0136 -
Pain Management Nursing : Official... Oct 2022This systematic review was conducted to determine the effect of parental presence on the child's pain intensity during invasive procedures. (Review)
Review
AIM
This systematic review was conducted to determine the effect of parental presence on the child's pain intensity during invasive procedures.
DESIGN
A systematic review.
METHOD
The systematic review was conducted in July 2019 and updated in December 2020 to include the latest research published during the publication process by scanning the articles in English. Scopus, Pubmed, Cochrane, Science Direct, MedLine databases were used for scanning. The keywords "parental presence", "family presence", "parent involvement", "invasive procedures", "venipuncture", "painful procedures", "child", "children", "pediatric" were used in the scanning. Preferred Reporting Items for Systematic reviews and Meta-Analyses protocol was followed to prepare the study and the report, and the systematic review was created according to the patient, intervention, comparison, outcomes (PICOS) strategy.
RESULTS
A total of 248 articles were reached, and the full texts of 18 articles were evaluated for eligibility. After the articles excluded by the full-text search were eliminated, six studies, involving 730 children with a sample aged between 0-12 years, were included in the analysis. In 4 studies, it was determined that having a parent with the child during the invasive procedure significantly decreased the pain level, and in 2 studies, there was no statistically significant decrease in the pain level of the children.
CONCLUSIONS
Parental presence and parental involvement during invasive procedures effectively reduced the children's pain levels. Since the number of studies with a high level of evidence regarding the effect of family participation on pain level is limited, it is recommended to conduct more randomized controlled studies.
Topics: Humans; Infant, Newborn; Infant; Child, Preschool; Child; Parents; Pain Measurement; Pain; Phlebotomy; Family
PubMed: 35523626
DOI: 10.1016/j.pmn.2022.03.011 -
Pediatric Critical Care Medicine : a... Jan 2023Blood sampling is a recognized contributor to hospital-acquired anemia. We aimed to bundle all published neonatal, pediatric, and adult data regarding clinical... (Review)
Review
OBJECTIVES
Blood sampling is a recognized contributor to hospital-acquired anemia. We aimed to bundle all published neonatal, pediatric, and adult data regarding clinical interventions to reduce diagnostic blood loss.
DATA SOURCES
Four electronic databases were searched for eligible studies from inception until May 2021.
STUDY SELECTION
Two reviewers independently selected studies, using predefined criteria.
DATA EXTRACTION
One author extracted data, including study design, population, period, intervention type and comparator, and outcome variables (diagnostic blood volume and frequency, anemia, and transfusion).
DATA SYNTHESIS
Of 16,132 articles identified, we included 39 trials; 12 (31%) were randomized controlled trials. Among six types of interventions, 27 (69%) studies were conducted in adult patients, six (15%) in children, and six (15%) in neonates. Overall results were heterogeneous. Most studies targeted a transfusion reduction ( n = 28; 72%), followed by reduced blood loss ( n = 24; 62%) and test frequency ( n = 15; 38%). Small volume blood tubes ( n = 7) and blood conservation devices ( n = 9) lead to a significant reduction of blood loss in adults (8/9) and less transfusion of adults (5/8) and neonates (1/1). Point-of-care testing ( n = 6) effectively reduced blood loss (4/4) and transfusion (4/6) in neonates and adults. Bundles including staff education and protocols reduced blood test frequency and volume in adults (7/7) and children (5/5).
CONCLUSIONS
Evidence on interventions to reduce diagnostic blood loss and associated complications is highly heterogeneous. Blood conservation devices and smaller tubes appear effective in adults, whereas point-of-care testing and bundled interventions including protocols and teaching seem promising in adults and children.
Topics: Adult; Infant, Newborn; Humans; Child; Anemia; Hemorrhage; Blood Transfusion; Phlebotomy
PubMed: 36269063
DOI: 10.1097/PCC.0000000000003094 -
Ethiopian Journal of Health Sciences Nov 2023Surgical treatment has transformed the course and outcome of congenital heart defects in high-income countries, but children with congenital heart diseases in...
BACKGROUND
Surgical treatment has transformed the course and outcome of congenital heart defects in high-income countries, but children with congenital heart diseases in sub-Saharan Africa, where access to cardiac surgery is limited, often experience the natural course of untreated lesions and their complications. The objective of this study was to determine the prevalence of hematologic derangements among Ethiopian children with unoperated cyanoticcongenital heart diseases, to identify factors associated with coagulopathy in this population, and to describe how these complications are managed in this setting.
METHODS
In this single-center cross-sectional study, we prospectively collected clinical and demographic data from children (<18 years) with cyanotic congenital heart diseases. Blood samples were collected to measure hematologic parameters. Polycythemia was defined as hematocrit >50% and thrombocytopenia as <150,000 per microliter.
RESULTS
Among 70 children recruited, the overall prevalence of polycythemia and thrombocytopenia was 63% (n=44) and 26% (n=18), respectively. On multivariate logistic regression analysis, hematocrit ≥65% (p-value=.024), and oxygen saturation <85% (p-value=.018) were independently associated with moderate or severe thrombocytopenia. Thirty-one (44%) patients had undergone therapeutic phlebotomy, and 84% (26/31) of these patients received iron supplementation.
CONCLUSION
We report a high prevalence of polycythemia and thrombocytopenia in Ethiopian children with untreated cyanotic congenital heart diseases. There was variable implementation of iron supplementation and therapeutic phlebotomy, highlighting the need to optimize supportive management strategies in this population to mitigate the risk of life-threatening complications.
Topics: Humans; Ethiopia; Female; Heart Defects, Congenital; Male; Cross-Sectional Studies; Polycythemia; Child, Preschool; Infant; Child; Thrombocytopenia; Prevalence; Hematocrit; Cyanosis; Adolescent; Prospective Studies; Phlebotomy
PubMed: 38784485
DOI: 10.4314/ejhs.v33i6.5 -
BMJ Case Reports Feb 2022
Topics: Humans; Phlebotomy; Vascular Surgical Procedures; Veins
PubMed: 35228222
DOI: 10.1136/bcr-2021-246286 -
Pediatric Research Sep 2022Phlebotomy-induced anemia (PIA) is universal and variable in degree among preterm infants and may contribute to neurodevelopmental risk. In mice, PIA causes brain tissue...
BACKGROUND
Phlebotomy-induced anemia (PIA) is universal and variable in degree among preterm infants and may contribute to neurodevelopmental risk. In mice, PIA causes brain tissue hypoxia, iron deficiency, and long-term sex-dependent neurobehavioral abnormalities. The neuroregulatory molecular pathways disrupted by PIA underlying these effects are unknown.
METHODS
Male and female pups were phlebotomized daily from postnatal day (P)3-P14 via facial venipuncture to target hematocrits of 25% (moderate, mPIA) and 18% (severe, sPIA). P14 hippocampal RNA from non-bled control and PIA mice was sequenced by next-generation sequencing to identify differentially expressed genes (DEGs) that were analyzed using Ingenuity Pathway Analysis.
RESULTS
mPIA females showed the least DEGs (0.5% of >22,000 genes) whereas sPIA females had the most (8.6%), indicating a dose-dependent effect. mPIA and sPIA males showed similar changes in gene expression (5.3% and 4.7%, respectively), indicating a threshold effect at mPIA. The pattern of altered genes induced by PIA indicates sex-specific and anemia-dose-dependent effects with increased pro-inflammation in females and decreased neurodevelopment in males.
CONCLUSION
These gene-expression changes may underlie the reduced recognition memory function in male and abnormal social-cognitive behavior in female adult mice following neonatal PIA. These results parallel clinical studies demonstrating sex-specific behavioral outcomes as a function of neonatal anemia.
IMPACT
Phlebotomy-induced anemia (PIA) in neonatal mice results in an altered hippocampal transcriptome and the severity of changes are dependent upon degree of anemia and sex of neonatal mice. The reported findings provide context to the sex-specific outcomes that have been reported in transfusion threshold clinical trials of preterm infants and therefore may inform treatment strategies that may be based on sex. These data advance the field by showing that consequences of PIA may be based in sex-specific transcriptomic alterations. Such changes may also result from other causes of neonatal anemia that also affect term infants.
Topics: Anemia; Anemia, Neonatal; Animals; Animals, Newborn; Female; Hippocampus; Humans; Infant, Newborn; Infant, Premature; Male; Mice; Phlebotomy; RNA; Transcriptome
PubMed: 34775474
DOI: 10.1038/s41390-021-01832-9 -
Journal of Pediatric Surgery Nov 2019Pediatric blunt solid organ injury management based on hemodynamic monitoring rather than grade may safely reduce resource expenditure and improve outcomes. Previously...
PURPOSE
Pediatric blunt solid organ injury management based on hemodynamic monitoring rather than grade may safely reduce resource expenditure and improve outcomes. Previously we have reported a retrospectively validated management algorithm for pediatric liver and spleen injuries which monitors hemodynamics without use of routine phlebotomy. We hypothesize that stable blunt pediatric isolated splenic/liver injuries can be managed safely using a protocol reliant on vital signs and not repeat hemoglobin levels.
METHODS
A prospective multi-institutional study was performed at three pediatric trauma centers. All pediatric patients from 07/2016-12/2017 diagnosed with liver or splenic injuries were identified. If appropriate for the protocol, only a baseline hemoglobin was obtained unless hemodynamic instability as defined in an age-appropriate fashion was determined by treating physician discretion. Descriptive statistics were conducted.
RESULTS
One hundred four patients were identified of which 38 were excluded from the protocol. There was a significant difference in abnormal shock index, pediatric age-adjusted (SIPA) values, hematocrit, and percentage of patients with hemoglobin less than 10 between the excluded and included patients. Of the 66 patients managed on the protocol, four patients had to be removed, two each on day one and day two. Of those four patients, only one required intervention. There were no mortalities.
CONCLUSION
A phlebotomy limiting protocol may be a safe option for stable pediatric splenic and liver injuries cared for in a pediatric trauma center with the resources for rapid intervention should the need arise. The differences in groups highlight the importance of utilizing this protocol in the correct patient population. Reduced phlebotomy offers the potential for reduced resource expenditure without any evidence of increased morbidity or mortality.
LEVEL OF EVIDENCE
Level IV.
Topics: Adolescent; Child; Child, Preschool; Clinical Protocols; Female; Hematocrit; Hemoglobins; Humans; Infant; Injury Severity Score; Liver; Male; Phlebotomy; Prospective Studies; Spleen; Trauma Centers; Vital Signs; Wounds, Nonpenetrating
PubMed: 31101423
DOI: 10.1016/j.jpedsurg.2019.04.021 -
The American Journal of Emergency... Jun 2022
Topics: Administration, Topical; Humans; Ketamine; Pain; Pain Measurement; Phlebotomy
PubMed: 34823916
DOI: 10.1016/j.ajem.2021.08.075 -
Journal of Clinical Epidemiology Oct 2021To estimate iron losses and disease severity following 19th century bloodletting in patients with pneumonia. (Review)
Review
OBJECTIVE
To estimate iron losses and disease severity following 19th century bloodletting in patients with pneumonia.
STUDY DESIGN AND SETTING
Benefits of bloodletting in pneumonia patients were contested during the 19th century. Although large blood volumes during infection were removed there was no systematic data collection assessing efficacy and knowledge of iron composition of blood was rudimentary. This observational analysis of historical data quantifies iron losses in pneumonia cases in relation to disease severity.
RESULTS
Based on one detailed case series average blood volume removed for survivors was 830 mL (range 114-2272 mL), and mean recovery times were shorter in patients bled within 2 days of illness (P < 0.001). Average iron removed was 446 mg with phlebotomy done ≤2 days of illness presentation and 347 mg after >2 days of illness (P = 0.012). Across several European hospitals average case fatality in pneumonia patients receiving phlebotomy was higher than in those treated without phlebotomy (19.9% vs. 12.8%, OR 1.55, 95% CI 1.38-1.74, P < 0.001).
CONCLUSION
Variable efficacy for bloodletting could at least in part be explained by altered iron status.
Topics: Adult; Bloodletting; Female; History, 20th Century; Humans; Iron; Iron Deficiencies; Male; Middle Aged; Pneumonia
PubMed: 34186196
DOI: 10.1016/j.jclinepi.2021.06.018 -
Journal of Integrative and... Jun 2022Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension. In this randomized-controlled... (Randomized Controlled Trial)
Randomized Controlled Trial
Study aim was to investigate the effects of therapeutic phlebotomy on ambulatory blood pressure in patients with grade 1 hypertension. In this randomized-controlled intervention study, patients with unmedicated hypertension grade 1 were randomized into an intervention group (phlebotomy group; 500 mL bloodletting at baseline and after 6 weeks) and a control group (waiting list) and followed up for 8 weeks. Primary endpoint was the 24-h ambulatory mean arterial pressure between the intervention and control groups after 8 weeks. Secondary outcome parameters included ambulatory/resting systolic/diastolic blood pressure, heart rate, and selected laboratory parameters (e.g., hemoglobin, hematocrit, erythrocytes, and ferritin). Resting systolic/diastolic blood pressure/heart rate and blood count were also assessed at 6 weeks before the second phlebotomy to ensure safety. A per-protocol analysis was performed. Fifty-three hypertension participants (56.7 ± 10.5 years) were included in the analysis ( = 25 intervention group, = 28 control group). The ambulatory measured mean arterial pressure decreased by -1.12 ± 5.16 mmHg in the intervention group and increased by 0.43 ± 3.82 mmHg in the control group (between-group difference: -1.55 ± 4.46, = 0.22). Hemoglobin, hematocrit, erythrocytes, and ferritin showed more pronounced reductions in the intervention group in comparison with the control group, with significant between-group differences. Subgroup analysis showed trends regarding the effects on different groups classified by serum ferritin concentration, body mass index, age, and sex. Two adverse events (AEs) (anemia and dizziness) occurred in association with the phlebotomy, but no serious AEs. Study results showed that therapeutic phlebotomy resulted in only minimal reductions of 24-h ambulatory blood pressure measurement values in patients with unmedicated grade 1 hypertension. Further high-quality clinical studies are warranted, as this finding contradicts the results of other studies.
Topics: Blood Pressure Monitoring, Ambulatory; Humans; Hypertension; Phlebotomy
PubMed: 35238614
DOI: 10.1089/jicm.2021.0396