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BMC Health Services Research Sep 2016The acquisition of needle-stick injuries (NSI) in a healthcare setting poses an occupational hazard of transmitting blood-borne pathogens from patients to healthcare... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The acquisition of needle-stick injuries (NSI) in a healthcare setting poses an occupational hazard of transmitting blood-borne pathogens from patients to healthcare workers (HCWs). The objective of this study was to systematically review the evidence about the efficacy and safety of using safety-engineered intravenous devices and safety-engineered phlebotomy devices by HCWs.
METHODS
We included randomized and non-randomized studies comparing safety-engineered devices to conventional/standard devices that lack safety features for delivering intravenous injections and/or for blood-withdrawal procedures (phlebotomy). The outcomes of interest included NSI rates, and blood-borne infections rates among HCWs and patients. We conducted an extensive literature search strategy using the OVID interface in October 2013. We followed the standard methods for study selection and data abstraction. When possible, we conducted meta-analyses using a random-effects model. We used the GRADE methodology to assess the quality of evidence by outcome.
RESULTS
We identified twenty-two eligible studies: Twelve assessed safety-engineered devices for intravenous procedures, five for phlebotomy procedures, and five for both. Twenty-one of those studies were observational while one was a randomized trial. All studies assessed the reduction in NSIs among HCWs. For safety-engineered intravenous devices, the pooled relative risk for NSI per HCW was 0.28 [0.13, 0.59] (moderate quality evidence). The pooled relative risk for NSI per device used or procedure performed was 0.34 [0.08,1.49] (low quality evidence). For safety-engineered phlebotomy devices, the pooled relative risk for NSI per HCW was 0.57 [0.38, 0.84] (moderate quality evidence). The pooled relative risk for NSI per device used or procedure performed was 0.53 [0.43,0.65] (moderate quality evidence). We identified no studies assessing the outcome of blood-borne infections among healthcare workers or patients.
CONCLUSION
There is moderate-quality evidence that the use of safety-engineered devices in intravenous injections and infusions, and phlebotomy (blood-drawing) procedures reduces NSI rates of HCWs.
Topics: Blood-Borne Pathogens; Equipment Design; Health Personnel; Humans; Injections, Intramuscular; Injections, Intravenous; Injections, Subcutaneous; Needlestick Injuries; Phlebotomy; Protective Devices; Randomized Controlled Trials as Topic; Safety
PubMed: 27581947
DOI: 10.1186/s12913-016-1705-y -
The Cochrane Database of Systematic... Mar 2017Hereditary haemochromatosis is a genetic disorder related to proteins involved in iron transport, resulting in iron load and deposition of iron in various tissues of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hereditary haemochromatosis is a genetic disorder related to proteins involved in iron transport, resulting in iron load and deposition of iron in various tissues of the body. This iron overload leads to complications including liver cirrhosis (and related complications such as liver failure and hepatocellular carcinoma), cardiac failure, cardiac arrhythmias, impotence, diabetes, arthritis, and skin pigmentation. Phlebotomy (venesection or 'blood letting') is the currently recommended treatment for hereditary haemochromatosis. The optimal treatment of hereditary haemochromatosis remains controversial.
OBJECTIVES
To assess the comparative benefits and harms of different interventions in the treatment of hereditary haemochromatosis through a network meta-analysis and to generate rankings of the available treatments according to their safety and efficacy. However, we found only one comparison. Therefore, we did not perform the network meta-analysis and we assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and randomised clinical trials registers to March 2016 to identify randomised clinical trials on treatments for hereditary haemochromatosis.
SELECTION CRITERIA
We included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with hereditary haemochromatosis. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various interventions compared with each other or with inactive treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models with RevMan 5 based on available-participant analysis. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.
MAIN RESULTS
Three trials with 146 participants met the inclusion criteria of this review. Two parallel group trials with 100 participants provided information on one or more outcomes. The remaining trial was a cross-over trial, with no usable data for analysis. All the trials were at high risk of bias. Overall, all the evidence was of very low quality. All three trials compared erythrocytapheresis (removal of red cells only, instead of whole blood) versus phlebotomy. Two of the trials shared the same first author. The mean or median age in the three trials ranged from 42 to 55 years. None of the trials reported whether the included participants were symptomatic or asymptomatic or a mixture of both. Two trials were conducted in people who were haemochromatosis treatment-naive. The trial that provided most data for this review excluded people with malignancy, heart failure, and serious cardiac arrhythmias. We found no trials assessing iron-chelating agents.Only one of the trials with 38 participants reported no short-term mortality and no serious adverse events at the end of the short-term follow-up (eight months). Two trials reported the proportion of people with adverse events: 10/49 (20.4%) in the erythrocytapheresis group versus 11/51 (21.6%) in the phlebotomy group. One of these two trials provided data on adverse event rates (42.1 events per 100 participants with erythrocytapheresis versus 52.6 events per 100 participants with phlebotomy). There was no evidence of differences in the proportion of people with adverse events and the number of adverse events (serious and non-serious) between the groups (proportion of people with adverse events: OR 0.93, 95% CI 0.36 to 2.43; participants = 100; trials = 2; number of adverse events: rate ratio 0.80, 95% CI 0.32 to 2.03; participants = 38; trial = 1). There was no difference between the groups regarding short-term health-related quality of life (mean difference (MD) 1.00, 95% CI -10.80 to 12.80; participants = 38; trials = 1). This outcome was measured using EQ-VAS (range: 0 to 100 where a higher score indicates better health-related quality of life). None of the trials reported mortality beyond one year, health-related quality of life beyond one year, liver transplantation, decompensated liver disease, cirrhosis, hepatocellular carcinoma, diabetes, or cardiovascular complications during the long-term follow-up.The two trials that provided data for this review were funded by parties with no vested interest in the results; the source of funding of the third trial was not reported.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence to determine whether erythrocytapheresis is beneficial or harmful compared with phlebotomy. Phlebotomy has less equipment requirements and remains the treatment of choice in people with hereditary haemochromatosis who require blood letting in some form. However, it should be noted that there is no evidence from randomised clinical trials that blood letting in any form is beneficial in people with hereditary haemochromatosis. Having said this, a trial including no treatment is unlikely to be conducted. Future trials should compare different frequencies of phlebotomy and erythrocytapheresis versus phlebotomy with and without different iron-chelating agents compared with each other, and with placebo. Such trials should include long-term follow-up of participants (e.g. using national record linkage databases) to determine whether treatments are beneficial or harmful in terms of clinical outcomes such as deaths, health-related quality of life, liver damage and its consequences, heart damage and its consequences, and other outcomes that are of importance to people with hereditary haemochromatosis.
Topics: Adult; Cytapheresis; Erythrocytes; Hemochromatosis; Humans; Middle Aged; Phlebotomy; Quality of Life; Randomized Controlled Trials as Topic; Time Factors
PubMed: 28273330
DOI: 10.1002/14651858.CD011647.pub2 -
Transplantation Direct Apr 2022During the past 2 decades, transfusion requirements have decreased drastically during orthotopic liver transplantation (OLT), and transfusion-free transplantation is...
BACKGROUND
During the past 2 decades, transfusion requirements have decreased drastically during orthotopic liver transplantation (OLT), and transfusion-free transplantation is nowadays increasingly common. Understanding that liberal intravenous volume loading in cirrhotic patients may have detrimental consequences is key. In contrast, phlebotomy is a method to lower central venous pressure and portal venous pressure. The objective of this study was to determine the effectiveness and safety of phlebotomy in the early phase of blood transfusion, blood loss, renal function, and mortality.
METHODS
The present study evaluated the impact of phlebotomy on bleeding, transfusion rate, renal dysfunction, and mortality in 1000 consecutive OLTs. Two groups were defined and compared using phlebotomy. Multivariate logistic and linear regression models were used to determine predictors of bleeding, red blood cell (RBC) transfusion, renal dysfunction, and mortality.
RESULTS
A mean of 0.7 ± 1.5 RBC units was transfused per patient for 1000 OLTs, 75% did not receive any RBCs, and the median and interquartile range (25-75) were 0 for all blood products transfused. The phlebotomy was associated with decreased transfusion (RBCs, plasma, platelets, cryoprecipitate, albumin), with less bleeding, and with an increased survival rate, both 1 mo and 1 y. Phlebotomy was not associated with renal dysfunction.
CONCLUSIONS
The practice of phlebotomy to lower portal venous pressure was associated with reduced blood product transfusions and blood loss during liver dissection without deleterious effect on renal function.
PubMed: 35372673
DOI: 10.1097/TXD.0000000000001258 -
JAMA Aug 2014
Topics: Alcohol Drinking; Arthritis, Reactive; Biopsy; Ferritins; Hemochromatosis; Humans; Liver; Male; Middle Aged; Obesity; Phlebotomy
PubMed: 25138336
DOI: 10.1001/jama.2014.302 -
Annals of Hematology Mar 2023Polycythemia vera (PV) is a myeloproliferative neoplasm associated with increased risk of thrombotic events (TE) and death. Therapeutic interventions, phlebotomy and... (Observational Study)
Observational Study
Polycythemia vera (PV) is a myeloproliferative neoplasm associated with increased risk of thrombotic events (TE) and death. Therapeutic interventions, phlebotomy and cytoreductive medications, are targeted to maintain hematocrit levels < 45% to prevent adverse outcomes. This retrospective observational study examined medical and pharmacy claims of 28,306 PV patients initiating treatment for PV in a data period inclusive of 2011 to 2019. Study inclusion required ≥ 2 PV diagnosis codes in the full data period, at least 1 year of PV treatment history, and ≥ 1 prescription claim and medical claim in both 2018 and 2019. Patients having ≥ 2 hematocrit (HCT) test results in linked outpatient laboratory data (2018-2019) were designated as the HCT subgroup (N = 4246). Patients were characterized as high- or low-risk at treatment initiation based on age and prior thrombotic history. The majority of patients in both risk groups (60% of high-risk and 83% of low-risk) initiated treatment with phlebotomy monotherapy, and during a median follow-up period of 808 days, the vast majority (81% low-risk, 74% high-risk) maintained their original therapy during the follow-up period. Hematocrit control was suboptimal in both risk groups; 54% of high-risk patients initiating with phlebotomy monotherapy sometimes/always had HCT levels > 50%; among low-risk patients, 64% sometimes/always had HCT levels above 50%. Overall, 16% of individuals experienced at least 1 TE subsequent to treatment initiation, 20% (n = 3920) among high-risk and 8% (n = 629) among low-risk patients. This real-world study suggests that currently available PV treatments may not be used to full advantage.
Topics: Humans; Polycythemia Vera; Thrombosis; Myeloproliferative Disorders; Phlebotomy; Risk Factors
PubMed: 36637474
DOI: 10.1007/s00277-023-05089-6 -
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 -
Medicine Mar 2022We aimed to determine the upper and lower cutoff values to simplify the diagnosis of gestational diabetes mellitus (GDM). We investigated the 50-g oral glucose tolerance...
We aimed to determine the upper and lower cutoff values to simplify the diagnosis of gestational diabetes mellitus (GDM). We investigated the 50-g oral glucose tolerance test (OGTT) results from 1441 pregnancies and identified 423 gravidas who underwent the 100-g OGTT from 2011 to 2019. We collected the results of 50- and 100-g OGTTs. Moreover, we obtained the sum of the 50-g OGTT and 0-hour values, and the sum of those levels and 1-hour values. We determined the upper cutoff at 50-g OGTT, 0-, 1-hour, sum of 50-g OGTT and 0-hour results, and sum of those levels and 1-hour results for the confirmation of GDM. Also, we determined the lower cutoff at these tests for the exclusion of GDM. The upper cutoffs in 50-g OGTT, 0-, 1-hour, the sum of 50-g OGTT and 0-hour were 222, 115, 212, and 315 mg/dL, respectively. The lower cutoffs in 50-g OGTT, 0-, 1-hour, the sum of 50-g OGTT and 0-hour were 131, 65, 151, and 208 mg/dL, respectively. In addition, we discovered that the upper and lower cutoffs in the sum of 50-g OGTT, 0- and 1-hour values were >516 and <373 mg/dL, respectively. We implemented these cutoffs to our study group at 50-g OGTT and 0-, 1-hour of 100-g OGTT. It could omit 2- and 3-hour sampling in 216 gravidas (51.1%). Our approach was able to simplify GDM diagnostic steps in half of our study group.
Topics: Blood Glucose; Blood Specimen Collection; Diabetes, Gestational; Female; Glucose Tolerance Test; Humans; Phlebotomy; Pregnancy
PubMed: 35451404
DOI: 10.1097/MD.0000000000029025 -
Indian Journal of Medical Ethics 2015Phlebotomy is one of the common invasive procedures carried out all round the globe. The practice of phlebotomy varies widely. In terms of the technique, the procedure...
Phlebotomy is one of the common invasive procedures carried out all round the globe. The practice of phlebotomy varies widely. In terms of the technique, the procedure may involve the use of a syringe or a vacutainer, and as for the technicians, some are not specifically trained to perform the procedure and others are qualified phlebotomists. Finally, some may receive training on the job, while others undergo formal, focused training. However, the underlying ethical principles of respect for autonomy and informed consent do not change. This commentary, which is supported by data collected during training in phlebotomy, reflects on the ethical issue of obtaining consent for the procedure.
Topics: Allied Health Personnel; Awareness; Clinical Competence; Humans; India; Informed Consent; Personal Autonomy; Phlebotomy
PubMed: 25920975
DOI: 10.20529/IJME.2015.037 -
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