Feasibility, acceptability, and safety of a novel device for self-collecting capillary blood samples in clinical trials in the context of the pandemic and beyond.

BACKGROUND: Home blood self-collection devices can enable remote monitoring, but their implementation requires validation. Our objectives were to explore (i) the impact of sampling sites and topical analgesia on capillary blood volume and pain perception and (ii) the safety, acceptability, and failure of capillary self-collection among adults and children using the Tasso-SST device. METHODS: We conducted a two-phase study. The investigational phase consisted of two on-site cross-sectional studies in healthy adult participants (≥ 12 years) and children (1-17 years) with their accompanying parent. Adults received 4 capillary samplings, where puncture sites and topical analgesia were randomized in a factorial design, and a venipuncture; children (and one parent) had one capillary sampling. The two co-primary outcomes were blood volume and pain. The implementation phase was conducted in two multicentre trials in participants choosing remote visits; blood volume, collection failure, adverse events, and satisfaction were documented. RESULTS: In the investigational phase, 90 participants and 9 children with 7 parents were enrolled; 15 adults and 2 preschoolers participated in the implementation phase. In the adult investigational study, the device collected a median (25%, 75%) of 450 (250, 550) µl of blood with no significant difference between the puncture site, topical analgesia, and its interaction. Using topical analgesia reduced pain perception by 0.61 (95% CI: 0.97, 0.24; P <0.01) points on the 11-point scale; the pain reduction varied by puncture site, with the lower back showing the most significant decrease. Overall, combining all studies and phases, the median volume collected was 425 (250, 500) µl, and the device failure rate was 4.4%; minor adverse effects were reported in 8.9% of the participants, all were willing to use the device again. CONCLUSION: Capillary blood self-collection, yielding slightly less than 500 µl, proves to be a safe and relatively painless method for adults and children, with high satisfaction and low failure rates. The puncture site and topical analgesia do not affect blood volume, but topical analgesia on the lower back could reduce pain.

Evaluation of a scoring system for vein suitability in platelet apheresis donors.

INTRODUCTION: Donor vein assessment for the selection of good quality veins is crucial for a successful apheresis procedure. This study intends to find out the effectiveness of a vein assessment scoring tool (VST) used and found to be effective in selecting whole blood donors to reduce the difficulty in identifying good quality veins for the plateletpheresis procedure. MATERIALS AND METHODS: This was a prospective observational study on platelet apheresis donors with the application of a VST consisting of three vein descriptor parameters (vein visibility, vein palpability, and vein size) with 5 Likert-type responses constituting a score of 0-12 for each arm. Two vein assessors independently evaluated the vein in both arms and marked their responses blinded from each other as well from the principal investigator. The scores were then calculated and analyzed at the end of the study for their association with phlebotomy and procedural outcomes. RESULTS: A total of 190 donors were recruited. The mean scores for the arms with successful and failed phlebotomy were 9.1 and 9.4 (SD 2.3), respectively. The intra-class correlation Alpha Cronbach value was 0.834 and 0.837 for total scoring in the left arm and right arm, respectively, between the two assessors. Scores neither showed a correlation with other outcomes like low flow alarms, hematoma formation, number of phlebotomy attempts, and procedure completion. CONCLUSION: The study showed that the vein score tool did not truly predict the phlebotomy outcome in apheresis donors, though there was a good degree of inter-assessor reliability.

At a glance: a guide to venepuncture in adults.

This article will provide clinical guidance on carrying out venepuncture on an adult. It will discuss site, equipment selection and aseptic non-touch technique. The aims are to increase knowledge of the anatomical structures associated with venepuncture, demonstrate the clinical procedural technique of venepuncture, and provide an awareness of the dangers and complications of this invasive technique.

Blood Samples from Midline Catheters: Clinically Equivalent to Venipuncture.

PowerGlide Pro™ Midline Catheters, manufactured by Becton Dickinson, are marketed as capable of obtaining blood specimens. However, there is insufficient research to validate the laboratory results collected from these specialty catheters. The purpose of this research study was to determine whether blood samples obtained via venipuncture and samples obtained directly from a midline catheter are clinically equivalent. A qualitative study was completed per recommendations published in Clinical and Laboratory Standards Institute (CLSI) standards EP-05-A3 to determine whether the 2 modalities are clinically equivalent. A 12-point correlation study was performed, comparing blood results from phlebotomy venipuncture and midline catheter blood draws for 20 successful participants. Results were compared with an EP Evaluator. Report interpretation was completed using the 2-instrument comparison module to determine whether the 2 methods were clinically equivalent. All correlated specimens resulted within the medically acceptable total allowable error, proving the 2 methods clinically equivalent. The study concluded that blood draws from midline catheters are clinically equivalent to venipuncture and are an acceptable form of specimen collection for laboratory studies.

The effect of vibrating cold application and puppet use on pain and fear during phlebotomy in children: A randomized controlled study.

BACKGROUND: Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. OBJECTIVES: This study was conducted to evaluate the effects of Bee Buzzy and puppet use on pain and fear during phlebotomy in children. METHODS: This randomized controlled study was conducted in the pediatric phlebotomy unit of a university hospital. The CONSORT checklist was used in this study. The sample of 3-6 years children (n = 105) was divided into groups by block randomization. Children's pain and fear scores were evaluated with the Wong-Baker Faces Pain Rating Scale and Children's Fear Scale by the parents and the nurse who attempted phlebotomy during phlebotomy. RESULTS: A statistically significant difference was found between the Bee Buzzy and puppet and Bee Buzzy and control groups in pain scores (p < .05). Pain scores were lower in the Bee Buzzy group than in the puppet and control groups. A statistical difference was found between Bee Buzzy and the control group or puppet and control group according to all fear scores (p < .05). Fear scores were lower in the Bee Buzzy and puppet group (p < .05). CONCLUSIONS: The results show that the use of Bee Buzzy during phlebotomy has a pain-relieving effect, and the use of Bee Buzzy and puppet has an anti-fear effect in 3-6-year-old children. IMPLICATIONS FOR PRACTICES: The use of Bee-Buzzy and puppets is effective in reducing pain and fear in children as they increase effective communication and distract attention. CLINICAL TRIAL REGISTRATION: National Institutes of Health (NIH), ClinicalTrials.gov, NCT05827783.

The effect of two different methods on reducing the pain and fear during phlebotomy to children: A randomized controlled trial.

INTRODUCTION: Reducing pain and fear during painful medical procedures in children is important since mismanagement of pain causes the child and parent to feel anxious, which can have negative long-term consequences. This study aimed to evaluate the effects of two different distraction methods in reducing pain and fear during the phlebotomy procedure in children. METHOD: The study, which has a randomized controlled experimental design was conducted between July and October 2020 with 111 children aged 6-12 years who underwent phlebotomy in the emergency department of a public hospital and their parents. The children were randomly assigned to soap bubble blowing (n:37), ball squeezing (n:37) and control (n:37) groups. During the phlebotomy, soap bubble blowing, and ball squeezing methods were used as active distraction methods. Data were collected using the Wong Baker Faces Pain Rating Scale, and the Children's Fear Scale. RESULTS: The pain scores of the soap bubble blowing group and the ball squeezing group during the phlebotomy procedure were found to be lower than the control group (p < 0.001). In addition, the soap bubble blowing group had lower fear scores than the ball squeezing and control groups (p < 0.001). CONCLUSION: The active distraction methods used in the study reduced pain and fear during the phlebotomy procedure. In addition, the method of soap bubble blowing was found to be a more effective method in reducing fear. Distraction methods should be used as a nursing intervention to reduce pain and fear during the phlebotomy procedure in children.

Blood alcohol concentration in the clinical laboratory: a narrative review of the preanalytical phase in diagnostic and forensic testing.

The analysis of blood alcohol concentration (BAC), a pivotal toxicological test, concerns acute alcohol intoxication (AAI) and driving under the influence (DUI). As such, BAC presents an organizational challenge for clinical laboratories, with unique complexities due to the need for forensic defensibility as part of the diagnostic process. Unfortunately, a significant number of scientific investigations dealing with the subject present discrepancies that make it difficult to identify optimal practices in sample collection, transportation, handling, and preparation. This review provides a systematic analysis of the preanalytical phase of BAC that aims to identify and explain the chemical, physiological, and pharmacological mechanisms underlying controllable operational factors. Nevertheless, it seeks evidence for the necessity to separate preanalytical processes for diagnostic and forensic BAC testing. In this regard, the main finding of this review is that no literature evidence supports the necessity to differentiate preanalytical procedures for AAI and DUI, except for the traceability throughout the chain of custody. In fact, adhering to correct preanalytical procedures provided by official bodies such as European federation of clinical chemistry and laboratory medicine for routine phlebotomy ensures both diagnostic accuracy and forensic defensibility of BAC. This is shown to depend on the capability of modern pre-evacuated sterile collection tubes to control major factors influencing BAC, namely non-enzymatic oxidation and microbial contamination. While certain restrictions become obsolete with such devices, as the use of sodium fluoride (NaF) for specific preservation of forensic BAC, this review reinforces the recommendation to use non-alcoholic disinfectants as a means to achieve "error-proof" procedures in challenging operational environments like the emergency department.

Virtual reality vs. buzzy®. efficacy in pain and anxiety management during pediatric venipuncture. Systematic review and meta-analysis.

PROBLEM: Non-pharmacological distraction methods are novel alternatives that can help to alleviate pain and anxiety generated by venipuncture in the pediatric population. The aim is to determine the effectiveness of virtual reality, compared to cold and vibration devices (Buzzy® device), as a distraction method used during venipuncture in the management of pain and anxiety in children. ELIGIBILITY CRITERIA: Clinical trials, cohort and quasi-experimental studies, published between 2017 and 2022, in Spanish or English and pediatric age, found in Medline, the Cochrane Library, Scopus, Web Of Science, CINAHL and Embase databases. SAMPLE: Twenty-one studies were included and ten met the criteria for meta-analysis. RESULTS: Fifty-seven percent of the studies evaluate virtual reality, 33.3% the Buzzy® device and 9.5% both comparatively. The effectiveness of virtual reality in reducing pain (66.6%, n = 14) and anxiety (47.6%, n = 10) compared to standard care (control group), 95% CI = 1.53 [0.91-2.16], p < 0.001, I2 = 78% and 95% CI = 1.53 [1.16-1.90]), p < 0.001, I2 = 77% respectively is demonstrated. Similarly, the effectiveness of Buzzy® in reducing pain (42.9%, n = 9) and anxiety (23.8%, n = 5), 95% CI = 1.62 [0.90-2.34], p < 0.001, I2 = 94% and 95% CI = 1.40 [0.06-2.20, p < 0.001, I2 = 91% respectively is demonstrated. Comparatively, there is no significant difference between both methods 95% CI = 0.29 [-0.19-0.78], p = 0.24, I2 = 81%. CONCLUSIONS: The methods studied are effective in relieving pain and anxiety during venipuncture. Further research is needed on the level of satisfaction, adverse effects and cost-benefit. IMPLICATIONS: This study provides evidence of novel tools in daily practice to provide more humane, holistic and quality care.

Distribution of videos demonstrating best practices in preventing hemolysis is associated with reduced hemolysis among nurse-collected specimens in hospitals.

BACKGROUND: Minimizing hemolysis during phlebotomy ensures accurate chemistry results and reduces test cancellations and specimen recollections. We developed videos demonstrating best practices to reduce hemolysis and tested whether distribution to clinical nurse educators (CNEs) for provision to nursing staff affected the degree of specimen hemolysis in hospital inpatient units and outpatient clinics. METHODS: Videos of common blood collections demonstrating best practices to reduce hemolysis were filmed and then distributed via email link to all hospital-based CNEs in Calgary, Alberta, Canada. (https://vimeo.com/user18866730/review/159869683/a0cec9827f). Roche Cobas hemolysis index (H-index) results from specimens collected +/- 12 months from the date of video distribution were extracted from Roche Cobas IT middleware (cITM) and linked to collection location. An interrupted time series (ITS) analysis with collection location as the unit of anlaysis was used to quantify impact of video distribution on the trajectory of weekly mean log-H-index weighted by inverse variance. RESULTS: In +/- 3 months of data flanking video distribution (n = 137 241 collections), where overall impact was strongest, H-index trajectory (change in units per week) decreased immediately following video distribution (-5.7% / week, p < 0.01). This was accompanied by a 22% drop in overall H-index from the week before to the week after video distribution (y-intercept change, or gap). There was also a small but significant overall decrease in the proportion of hemolyzed specimens (-0.3%, p < 0.01). These changes were not observed at all collection locations, and in fact increases occured at some locations. CONCLUSIONS: We developed a novel and convenient educational aid that, when distributed, was associated with beneficial changes in specimen hemolysis at hospital inpatient units and outpatient clinics. Including it in ongoing nursing education will fill a knowledge gap that may help to reduce specimen hemolysis.

A case of Pseudo-Lowering of Blood Routine Results caused by Improper Blood Collection Operation.

BACKGROUND: Unqualified samples directly affect the accuracy of laboratory test results. Some links in the preanalysis stage are prone to produce unqualified samples that are difficult to identify, leading to inaccurate test results and affecting clinical diagnosis and treatment. METHODS: This paper reports a case of pseudo-lowering of blood routine results caused by improper blood collection operation. RESULTS: The blood routine samples caused by improper blood collection operation by nurses were diluted by the sealing solution of the indwelling needle, which resulted in inaccurate test results. CONCLUSIONS: The laboratory should pay attention to the quality control in the preanalysis stage and identify unqualified samples in time, provide reliable diagnostic basis for clinical practice, and avoid the occurrence of adverse events.

The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study.

Objective: The use of virtual reality (VR) as a non-pharmacologic method may enable children to tolerate invasive procedures in a hospital setting easily and feel less pain. This study aimed at determining the effect of using a VR headset during venipuncture on pain level, heart rate (HR), and oxygen saturation values in children aged 7-12 years old. Materials and Methods: This was a randomized controlled experimental study. This study included 102 children (experimental group: 52; control group: 50) who visited a pediatric outpatient clinic of a university hospital in Turkey between May 2018 and May 2019. Data were collected using the Child and Family Information Form, State Anxiety Inventory for Children, Faces Pain Scale-Revised (FPS-R). Before venipuncture, state anxiety and pain scores of the children were evaluated. The children in the experimental group wore VR headsets during venipuncture. The children in the control group underwent standard venipuncture procedure. Pain scores were evaluated again in both groups after the venipuncture. Before, during, and after the venipuncture, pulse and oxygen saturation values were measured. Results: It was determined that post-procedure pain score was 1.46 ± 1.49 in the experimental group and 4.44 ± 2.26 in the control group. Post-venipuncture pain mean scores were significantly lower in the experimental group than those of the children in the control group (Z = -6.574; P = 0.001). Secondary outcomes: The mean HR during the procedure was significantly lower in the experimental group (99.27 ± 18.34/min) than in the control group (108.20 ± 21.42/min) (P = 0.026; t = -2.265). There was no statistically significant difference between the before and after the procedure difference of oxygen saturation values (Experimental group: -0.15 ± 1.54; Control Group: 0.04 ± 0.93) between groups (Z = -0.023; P = 0.982). Conclusion: It was determined that post-venipuncture pain mean scores were significantly lower in the experimental group than in the control group. VR is effective to reduce the pain of children during venipuncture. VR headsets may be recognized as effective instruments to reduce the pain level of children in hospital settings. (Clinicaltrials.gov: NCT04950478).

The Effectiveness of the Buzzy Device in Reducing Pain in Children Undergoing Venipuncture: A Single-Center Experience.

OBJECTIVES: Needle-related procedures are among the most important sources of pain in children in different health care settings. Our study was aimed to evaluate the effectiveness of Buzzy (MMJ Labs, Atlanta, Ga.), a palm-sized bee/ladybug-shaped device combining vibration and cold, as a nonpharmacological strategy to manage needle-related pain in children. METHODS: In this single-center, randomized (1:1) controlled open-label study, we enrolled patients aged from 1 month to 18 years who had to undergo a planned outpatient blood sampling in Pisa University Hospital's Department of Pediatrics and randomly allocated them to either the BUZZY group (intervention group) or NO BUZZY group (control group). Pain was estimated using proper pain scales according to age. RESULTS: Between May 2021 and January 2022, 234 children aged 8.8 ± 5.1 years (50.8% girls) were enrolled and 117 were treated with the Buzzy device. In the study population, pain inversely correlated with age (r = -0.52, P < 0.001); the intervention group showed significantly lower pain (2.5 ± 2.4 vs 4.7 ± 2.8, P < 0.001) and no difference was found between boys and girls. Significant reduction in pain scores was confirmed when stratifying children by age (29 days to <3 years, P = 0.002; ≥3 to ≤8 years, P < 0.001; >8 years, P < 0.001). CONCLUSIONS: The Buzzy device effectively reduces pain caused by percutaneous antecubital venipuncture in children in different age groups and represents a cheap and easy-to-use strategy to manage routine needle-related procedures.

Individualized Blind Techniques for Puncture of Intrathoracic and Extrathoracic Subclavian Vein: Three Simple Experience Tips.

BACKGROUND: Although several procedures of subclavian venipuncture have been reported, no standard method has been established yet. The purpose of this study was to investigate some more accurate and improved blind puncture tips. METHODS: A prospective study was conducted on patients who underwent cardiac radio-frequency ablation with the blind technique of subclavian venipuncture from August 2018 to June 2022. All patients were randomly assigned to an intrathoracic approach group or extrathoracic approach group. Each group of patients followed their own specific puncture scheme and tips. RESULTS: About 371 punctures were included. Blind subclavian venipunctures were performed with 98.9% technical success and without complications in all patients. The over-all success rate with an intrathoracic and extrathoracic approach was equivalent (96.7% vs. 98.3%, P =.23). The intrathoracic group showed a higher first-pass success compared with the extrathoracic group (91.9% vs. 80.2%, P = 0.003, respectively). CONCLUSION: We localized the landmark/reference and skin puncture site of an intrathoracic and extrathoracic subclavian venipuncture individually and quantitatively. These experiences make blind techniques more accurate and faster.

Coffee intake one hour prior to phlebotomy produces no clinically significant changes in routine biochemical test results.

Introduction: Although current guidelines recommend not drinking coffee prior to phlebotomy, our hypothesis is that drinking coffee does not affect the clinical interpretation of biochemical and haematological test results. Materials and methods: Twenty-seven volunteers were studied in basal state (T0) and 1h after (T1) drinking coffee. Routine haematological (Sysmex-XN1000 analyser) and biochemistry parameters (Vitros 4600 analyser) were studied. Results were compared using the Wilcoxon test (P < 0.05). A clinical change was considered when mean percent difference (MD%) was higher than the reference change value (RCV). Results: Coffee intake produced statistically, but not clinically, significant: i) increases in haemoglobin (P = 0.009), mean cell haemoglobin concentration (P = 0.044), neutrophils (P = 0.001), albumin (P = 0.001), total protein (P = 0.000), cholesterol (P = 0.025), high density lipoprotein cholesterol (P = 0.007), uric acid (P = 0.011), calcium (P = 0.001), potassium (P = 0.010), aspartate aminotransferase (P = 0.001), amylase (P = 0.026), and lactate dehydrogenase (P = 0.001), and ii) decreases in mean cell volume (P = 0.002), red cell distribution width (P = 0.001), eosinophils (P = 0.002), and lymphocytes (P = 0.001), creatinine (P = 0.001), total bilirubin (P = 0.012), phosphorus (P = 0.001), magnesium (P = 0.007), and chloride (P = 0.001). Conclusion: Drinking a cup of coffee 1 hour prior to phlebotomy produces no clinically significant changes in routine biochemical and haematological test results.

Factors impacting the pre-analytical quality of blood cultures-Analysis at a tertiary medical center.

BACKGROUND: Blood cultures (BC) are critical for the diagnosis of bloodstream infections, pathogen identification, and resistance testing. Guidelines recommend a blood volume of 8-10 mL per bottle as lower volumes result in decreased sensitivity. We aimed to evaluate factors for non-adherence to recommended volumes and assess the effects on diagnostic performance. METHODS: From February to April 2020, we measured collected blood volumes by weighing all BC containers from inpatient samples at the University Hospital Basel. Information on BC volumes was merged with clinical and microbiological data, as well as nursing staff schedules. We analyzed factors associated with (i) BC sampling volume, (ii) reaching recommended volumes (≥8 mL), (iii) BC positivity, and (iv) time to positivity using linear and generalized linear mixed effect models. RESULTS: We evaluated a total of 4'118 BC bottles collected from 686 patients. A total of 1'495 (36.3%) of all bottles contained the recommended filling volume of ≥8 mL. Using a central venous and arterial catheter for drawing blood resulted in an increase of filling volume by 0.26 mL (95% CI 0.10, 0.41) and 0.50 mL (95% CI 0.31, 0.69) compared to peripheral venipuncture, respectively. Each additional nursing staff working at the time of blood drawing was associated with 6% higher odds of achieving the recommended filling volume. We found no significant correlation between the filling volume and the positivity rate. CONCLUSION: Our results indicate critical pre-analytical quality markers linked to BC collection procedures to reach recommended collection volumes. No significant impact on the positivity rate was found.

Contamination of Blood Cultures From Arterial Catheters and Peripheral Venipuncture in Critically Ill Patients: A Prospective Multicenter Diagnostic Study.

BACKGROUND: Collecting blood cultures from indwelling arterial catheters is an attractive option in critically ill adult patients when peripheral venipuncture is difficult. However, whether the contamination proportion of blood cultures from arterial catheters is acceptable compared with that from venipuncture is inconclusive. RESEARCH QUESTION: Is contamination of blood cultures from arterial catheters noninferior to that from venipuncture in critically ill adult patients with suspected bloodstream infection? STUDY DESIGN AND METHODS: In this multicenter prospective diagnostic study conducted at five hospitals, we enrolled episodes of paired blood culture collection, each set consisting of blood drawn from an arterial catheter and another by venipuncture, were obtained from critically ill adult patients with cilinical indication. The primary measure was the proportion of contamination, defined as the number of false-positive results relative to the total number of procedures done. The reference standard for true bloodstream infection was blinded assessment by infectious disease specialists. We examined the noninferiority hypothesis that the contamination proportion of blood cultures from arterial catheters did not exceed that from venipuncture by 2.0%. RESULTS: Of 1,655 episodes of blood culture from December 2018 to July 2021, 590 paired blood culture episodes were enrolled, and 41 of the 590 episodes (6.9%) produced a true bloodstream infection. In blood cultures from arterial catheters, 33 of 590 (6.0%) were positive, and two of 590 (0.3%) were contaminated; in venipuncture, 36 of 590 (6.1%) were positive, and four of 590 (0.7%) were contaminated. The estimated difference in contamination proportion (arterial catheter - venipuncture) was -0.3% (upper limit of one-sided 95% CI, +0.3%). The upper limit of the 95% CI did not exceed the predefined margin of +2.0%, establishing noninferiority (P for noninferiority < .001). INTERPRETATION: Obtaining blood cultures from arterial catheters is an acceptable alternative to venipuncture in critically ill patients. CLINICAL TRIAL REGISTRATION: University Hospital Medical Information Network Center (UMIN-CTR); No.: UMIN000035392; URL: https://center6.umin.ac.jp/.

Hepcidin mimetics in polycythemia vera: resolving the irony of iron deficiency and erythrocytosis.

PURPOSE OF REVIEW: Development of hepcidin therapeutics has been a ground-breaking discovery in restoring iron homeostasis in several haematological disorders. The hepcidin mimetic, rusfertide, is in late-stage clinical development for treating polycythemia vera patients with a global phase 3 trial [NCT05210790] currently underway. Rusfertide serves as the first possible noncytoreductive therapeutic option to maintain haematocrit control and avoid phlebotomy in polycythemia vera patients. In this comprehensive review, we discuss the pathobiology of dysregulated iron metabolism in polycythemia vera, provide the rationale for targeting the hepcidin-ferroportin axis and elaborate on the preclinical and clinical trial evidence supporting the role of hepcidin mimetics in polycythemia vera. RECENT FINDINGS: Recently, updated results from two phase 2 clinical trials [NCT04057040 & NCT04767802] of rusfertide (PTG300) demonstrate that the drug is highly effective in eliminating the need for therapeutic phlebotomies, normalizing haematological parameters, repleting iron stores and relieving constitutional symptoms in patients with polycythemia vera. In light of these findings, additional hepcidin mimetic agents are also being evaluated in polycythemia vera patients. SUMMARY: Hepcidin agonists essentially serve as a 'chemical phlebotomy' and are poised to vastly improve the quality of life for phlebotomy requiring polycythemia vera patients.

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial.

INTRODUCTION: Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS: This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION: The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.

Real-world treatments and thrombotic events in polycythemia vera patients in the USA.

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.

Getting to zero: Impact of a device to reduce blood culture contamination and false-positive central-line-associated bloodstream infections.

OBJECTIVE: To assess the impact of initial specimen diversion device (ISDD) on inpatient and emergency department blood culture contamination (BCC), central-line-associated bloodstream infection (CLABSI) standardized infection ratios (SIRs), and antibiotic administration. DESIGN: Single-center quasi-experimental prospective cohort study wherein phlebotomists used traditional venipuncture with or without the ISDD while registered nurses (RNs) used traditional venipuncture. METHOD: BCC events among phlebotomists and RNs were observed and compared from March 17, 2019, through January 21, 2020, defined by contaminant detection in 1 of 4 bottles for matched sets or 1 of 2 bottles in both subsets for coagulase negative staphylococci. CLABSIs throughout this period were recorded and SIRs were calculated. Enhanced oversight took place through July 21, 2019, with chart review assessing antibiotic use for patients with possible BCC. RESULTS: Overall, 24% of blood cultures obtained were from patients in intensive care. Phlebotomists using traditional venipuncture (n = 4,759) had a 2.3% BCC rate; phlebotomists using the ISDD (n = 11,202) had a 0% BCC rate. RNs drew 7,411 BCs with a 0.8% BCC rate. The CLABSI SIR was decreased from 1.103 in 2017 and 0.658 in 2018 to 0.439 in 2019. The CLABSI incidence was 33%-64% of predicted value for each 2019 quarter. This range fell to 18%-37% after the exclusion of likely false-positive results. Among 42 patients with possible BCC under enhanced oversight, 2 patients were treated with prolonged antibiotic courses. CONCLUSIONS: ISDD use by phlebotomists was associated with BCC reduction and reduced false-positive CLABSI results. This patient-care quality improvement could constitute sustainable antibiotic stewardship expansion.