-
Advances in Therapy Sep 2022Lusutrombopag is an oral thrombopoietin receptor agonist (TPO-RA). Clinical trials have shown lusutrombopag's efficacy in reducing need for preoperative platelet... (Meta-Analysis)
Meta-Analysis
Systematic Review with Meta-Analysis: Efficacy and Safety of Lusutrombopag for Severe Thrombocytopenia in Patients with Chronic Liver Disease Undergoing Invasive Procedures.
INTRODUCTION
Lusutrombopag is an oral thrombopoietin receptor agonist (TPO-RA). Clinical trials have shown lusutrombopag's efficacy in reducing need for preoperative platelet transfusion in patients with chronic liver disease (CLD) and severe thrombocytopenia. This analysis assessed efficacy and safety of lusutrombopag in patients with severe thrombocytopenia and CLD undergoing planned invasive procedures.
METHODS
An electronic database search (through 1 December 2020) identified three randomised, placebo-controlled, double-blind clinical trials comparing lusutrombopag with placebo in patients with CLD and platelet count below 50 × 10/L scheduled to undergo a procedure with a perioperative bleeding risk. A random-effects meta-analysis examined treatment effect, with Cochrane Collaboration's tool assessing risk of bias.
RESULTS
The meta-analysis included 343 (lusutrombopag 3 mg, n = 173; placebo, n = 170) patients. More patients met the criteria for treatment response (platelet count at least 50 × 10/L and increase of at least 20 × 10/L from baseline anytime during the study) with lusutrombopag versus placebo (risk ratio [RR] 6.39; 95% confidence interval [CI] 3.69, 11.07; p < 0.0001). The primary efficacy outcome, proportion of patients requiring no platelet transfusion and no rescue therapy for bleeding for at least 7 days post procedure, was achieved by more patients treated with lusutrombopag versus placebo (RR 3.42; 95% CI 1.86, 6.26; p = 0.0001). The risk of any bleeding event was significantly lower with lusutrombopag compared to placebo (RR 0.55; 95% CI 0.32, 0.95; p = 0.03); conversely, thrombosis event rates were similar between lusutrombopag and placebo (RR 0.79; 95% CI 0.19, 3.24; p = 0.74).
CONCLUSION
This meta-analysis showed that treatment of severe thrombocytopenia with lusutrombopag in patients with CLD prior to a planned invasive procedure was efficacious and safe in increasing platelet counts, avoiding the need for platelet transfusions, and reducing risk of bleeding, thereby enhancing the certainty of evidence supporting the efficacy and safety of lusutrombopag.
Topics: Anemia; Chronic Disease; Cinnamates; Hemorrhage; Humans; Liver Diseases; Randomized Controlled Trials as Topic; Thiazoles; Thrombocytopenia
PubMed: 35836089
DOI: 10.1007/s12325-022-02235-w -
International Journal of Laboratory... Sep 2022Involvement of the central nervous system (CNS) by acute leukemias (ALs) has important implications for risk stratification and disease outcome. The clinical laboratory... (Review)
Review
BACKGROUND
Involvement of the central nervous system (CNS) by acute leukemias (ALs) has important implications for risk stratification and disease outcome. The clinical laboratory plays an essential role in assessment of cerebrospinal fluid (CSF) specimens from patients with ALs at initial diagnosis, at the end of treatment, and when CNS involvement is clinically suspected. The two challenges for the laboratory are 1) to accurately provide a cell count of the CSF and 2) to successfully distinguish blasts from other cell types. These tasks are classically performed using manual techniques, which suffer from suboptimal turnaround time, imprecision, and inconsistent inter-operator performance. Technological innovations in flow cytometry and hematology analyzer technology have provided useful complements and/or alternatives to conventional manual techniques.
AIMS
We performed a PRISMA-compliant systematic review to address the medical literature regarding the development and current state of the art of CSF blast identification using flow cytometry and laboratory hematology technologies.
MATERIALS AND METHODS
We searched the peer reviewed medical literature using MEDLINE (PubMed interface), Web of Science, and Embase using the keywords "CSF or cerebrospinal" AND "blasts(s)".
RESULTS
108 articles were suitable for inclusion in our systematic review. These articles covered 1) clinical rationale for CSF blast identification; 2) morphology-based CSF blast identification; 3) the role of flow cytometry; 4) use of hematology analyzers for CSF blast identification; and 5) quality issues. /L, which is much lower than the original machine count and platelet transfusion was warranted.
DISCUSSION
1) Clinical laboratory testing plays a central role in risk stratification and clinical management of patients with acute leukemias, most clearly in pediatric ALs; 2) studies focused on other patient populations, including adults and patients with AML are less prevalent in the literature; 3) improvements in instrumentation may provide better performance for the classification of CSF specimens.
CONCLUSION
Current challenges include: 1) more precisely characterizing the natural history of AL involvement of the CNS, 2) improvements in automated cell count technology of low cellularity specimens, 3) defining the role of flow MRD testing of CSF specimens and 4) improved recognition of specimen quality by clinicians and laboratory personnel.
Topics: Adult; Cerebrospinal Fluid; Child; Flow Cytometry; Hematology; Humans; Leukemia; Leukocyte Count; Technology
PubMed: 35785436
DOI: 10.1111/ijlh.13869 -
Pathogens (Basel, Switzerland) Jun 2022In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase,... (Review)
Review
In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel-Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.
PubMed: 35745493
DOI: 10.3390/pathogens11060639 -
European Review For Medical and... Mar 2022Robot-assisted prostatectomy is commonly performed for the management of prostate cancer. The literature has noted that prostate cancer patients are often prone to... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Robot-assisted prostatectomy is commonly performed for the management of prostate cancer. The literature has noted that prostate cancer patients are often prone to increased risk for thromboembolic complications. Normally, such situations call for long-term anticoagulant/antiplatelet therapy. However, the administration of these drugs is usually contraindicated prior to surgical intervention to limit intra- and post-operative hemorrhagic complications. Despite some recent evidence that continued administration of anticoagulant/antiplatelet drugs does not impact intra- and post-operative outcomes, no consensus in the literature exists concerning the influence of anticoagulant and antiplatelet drug administration on intra- and post-operative outcomes for robot-assisted prostatectomy. Our aim is to evaluate the influence of perioperative administration of anticoagulant and antiplatelet drugs in patients undergoing robot-assisted prostatectomy in terms of bleeding complication incidence, blood transfusion rate, blood loss, and hospital stay duration.
MATERIALS AND METHODS
The academic literature was systematically searched according to the PRISMA guidelines across five databases (Web of Science, EMBASE, CENTRAL, Scopus, and MEDLINE). Through this, we conducted a random-effect meta-analysis to evaluate the influence of perioperative administration of anticoagulant and antiplatelet drugs in patients undergoing robot-assisted prostatectomy in terms of bleeding complication incidence, blood transfusion rate, blood loss, and hospital stay duration.
RESULTS
From 993 studies, eight eligible studies containing 2516 patients (mean age: 65.7± 3.6 years) were selected for inclusion. Meta-analysis revealed a higher bleeding complication prevalence for patients receiving anticoagulants (event rate: 10.6%) compared to those receiving antiplatelets (3.4%). We also noted longer hospital stay durations for anticoagulant group patients (Hedge's g: -0.30) compared to antiplatelet group counterparts (g: -0.01).
CONCLUSIONS
The study provides preliminary evidence that anticoagulant drug administration results in higher bleeding complication incidence and longer hospital stay durations in patients undergoing robot-assisted prostatectomy relative to antiplatelet drug administration.
Topics: Aged; Anticoagulants; Hemorrhage; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Postoperative Complications; Prostatectomy; Prostatic Neoplasms; Robotics
PubMed: 35363358
DOI: 10.26355/eurrev_202203_28356 -
JPRAS Open Jun 2022The aim of this review was to identify studies that used thromboelastography (TEG) or rotational thromboelastometry (ROTEM) in microsurgical free flap reconstruction and... (Review)
Review
The aim of this review was to identify studies that used thromboelastography (TEG) or rotational thromboelastometry (ROTEM) in microsurgical free flap reconstruction and analyse whether it is a useful adjunct at predicting and identifying thrombotic complications. A search was conducted using the MEDLINE database using the keywords "thromboelastogram", "TEG", "thromboelastography", "free flaps" and "free tissue transfer" using a two-component search with the Boolean operators "OR" and "AND". Eight studies were retrieved using the search criteria. Seven studies met the inclusion criteria, and a further study was found citing several articles from the initial search. Combined, there were 528 patients who underwent 600 free flaps. A total of 10.3% (62) arterial and venous thromboses were reported in the studies, and the combined flap failure rate was 5.2% (26). A total of 67% (4/6) of the studies supported the use of TEG as a predictive tool to detect thromboses, including three retrospective case series and one prospective cohort, which were all statistically significant. There is low-quality evidence (level IV) that a pre-operative TEG and functional fibrinogen to platelet ratio of ≥42 can identify patients at risk of adverse post-operative thrombotic events following free flap surgery; however, further validation is required. Higher quality, standardised prospective or randomised control trials are required to further evaluate the predictive value of TEG. As a pre-operative screening tool, TEG can help to detect pathological changes in coagulation, aid in the transfusion of blood products, target anticoagulation therapy and predict possible adverse events aiding to further reduce patient morbidity.
PubMed: 35242985
DOI: 10.1016/j.jpra.2021.12.005 -
Digestive Diseases and Sciences Nov 2022Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM) analyze hemostatic function in patients with coagulopathy. We sought to quantify the impact of TEG... (Meta-Analysis)
Meta-Analysis
BACKGROUND/AIMS
Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM) analyze hemostatic function in patients with coagulopathy. We sought to quantify the impact of TEG and ROTEM-guided transfusion algorithms on blood product utilization in patients with cirrhosis undergoing non-surgical procedures.
METHODS
We performed a systematic review and meta-analysis on the utility of viscoelastic testing prior to non-surgical procedures to determine their impact on pre-procedural blood product use and post-procedural bleeding events. Studies comparing TEG or ROTEM-guided transfusions with standard-of-care (SOC) prior to non-surgical procedures in adult patients with cirrhosis were included. Primary outcomes were fresh frozen plasma (FFP) and platelet transfusion and secondary outcomes of post-procedure bleeding, transfusion-related complications, and mortality; and were reported as standardized mean differences (SMD) and risk ratios (RR).
RESULTS
Six studies (five randomized controlled trials and one cohort study) involving 367 patients met inclusion criteria. Compared with SOC, TEG/ROTEM-guided transfusions led to an overall decreased number of patients who received FFP transfusions (SMD = -0.93, 95% CI [-1.54, -0.33], p < 0.001) and platelets transfusions (SMD = -1.50, CI [-1.85, -1.15], p < 0.001). Total amount of FFP (SMD-0.86, p < 0.001) and platelet (SMD = -0.99, p < 0.001) transfused in the TEG/ROTEM group were also lower. Decreased pre-procedure transfusion in the TEG/ROTEM group did not result in increased post-procedure bleeding (RR = 0.61, p = 0.09) or in mortality (RR = 0.91, p = 0.93).
CONCLUSION
In patients with cirrhosis, TEG or ROTEM significantly reduces blood product utilization prior to non-surgical procedures, with no increase in post-procedure bleeding or mortality. TEG and ROTEM utilization can promote high-value care and improve transfusion stewardship in this population.
Topics: Adult; Humans; Cohort Studies; Thrombelastography; Blood Coagulation Disorders; Hemorrhage; Liver Cirrhosis; Transfusion Reaction; Hemostatics
PubMed: 35122595
DOI: 10.1007/s10620-021-07376-6 -
Pediatric Critical Care Medicine : a... Jan 2022Critically ill children frequently receive plasma and platelet transfusions. We sought to determine evidence-based recommendations, and when evidence was insufficient,...
Executive Summary of Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB).
OBJECTIVES
Critically ill children frequently receive plasma and platelet transfusions. We sought to determine evidence-based recommendations, and when evidence was insufficient, we developed expert-based consensus statements about decision-making for plasma and platelet transfusions in critically ill pediatric patients.
DESIGN
Systematic review and consensus conference series involving multidisciplinary international experts in hemostasis, and plasma/platelet transfusion in critically ill infants and children (Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding [TAXI-CAB]).
SETTING
Not applicable.
PATIENTS
Children admitted to a PICU at risk of bleeding and receipt of plasma and/or platelet transfusions.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
A panel of 29 experts in methodology, transfusion, and implementation science from five countries and nine pediatric subspecialties completed a systematic review and participated in a virtual consensus conference series to develop recommendations. The search included MEDLINE, EMBASE, and Cochrane Library databases, from inception to December 2020, using a combination of subject heading terms and text words for concepts of plasma and platelet transfusion in critically ill children. Four graded recommendations and 49 consensus expert statements were developed using modified Research and Development/UCLA and Grading of Recommendations, Assessment, Development, and Evaluation methodology. We focused on eight subpopulations of critical illness (1, severe trauma, intracranial hemorrhage, or traumatic brain injury; 2, cardiopulmonary bypass surgery; 3, extracorporeal membrane oxygenation; 4, oncologic diagnosis or hematopoietic stem cell transplantation; 5, acute liver failure or liver transplantation; 6, noncardiac surgery; 7, invasive procedures outside the operating room; 8, sepsis and/or disseminated intravascular coagulation) as well as laboratory assays and selection/processing of plasma and platelet components. In total, we came to consensus on four recommendations, five good practice statements, and 44 consensus-based statements. These results were further developed into consensus-based clinical decision trees for plasma and platelet transfusion in critically ill pediatric patients.
CONCLUSIONS
The TAXI-CAB program provides expert-based consensus for pediatric intensivists for the administration of plasma and/or platelet transfusions in critically ill pediatric patients. There is a pressing need for primary research to provide more evidence to guide practitioners.
Topics: Anemia; Child; Critical Care; Critical Illness; Erythrocyte Transfusion; Evidence-Based Medicine; Humans; Infant; Platelet Transfusion
PubMed: 34989711
DOI: 10.1097/PCC.0000000000002851 -
Pediatric Critical Care Medicine : a... Jan 2022To present a list of high-priority research initiatives for the study of plasma and platelet transfusions in critically ill children from the Transfusion and Anemia...
Research Priorities for Plasma and Platelet Transfusion Strategies in Critically Ill Children: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.
OBJECTIVES
To present a list of high-priority research initiatives for the study of plasma and platelet transfusions in critically ill children from the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.
DESIGN
Systematic review and consensus conference of international, multidisciplinary experts in platelet and plasma transfusion management of critically ill children.
SETTING
Not applicable.
PATIENTS
Critically ill pediatric patients at risk of bleeding and receiving plasma and/or platelet transfusions.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
A panel of 13 experts developed research priorities for the study of plasma and platelet transfusions in critically ill children which were reviewed and ratified by the 29 Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding experts. The specific priorities focused on the following subpopulations: severe trauma, traumatic brain injury, intracranial hemorrhage, cardiopulmonary bypass surgery, extracorporeal membrane oxygenation, oncologic diagnosis or stem cell transplantation, acute liver failure and/or liver transplantation, noncardiac surgery, invasive procedures outside of the operating room, and sepsis and/or disseminated intravascular coagulation. In addition, tests to guide plasma and platelet transfusion, as well as component selection and processing, were addressed. We developed four general overarching themes and 14 specific research priorities using modified Research and Development/University of California, Los Angeles methodology.
CONCLUSIONS
Studies are needed to focus on the efficacy/harm, dosing, timing, and outcomes of critically ill children who receive plasma and/or platelet transfusions. The completion of these studies will facilitate the development of evidence-based recommendations.
Topics: Anemia; Blood Component Transfusion; Child; Critical Care; Critical Illness; Erythrocyte Transfusion; Evidence-Based Medicine; Hemorrhage; Humans; Plasma; Platelet Transfusion; Research
PubMed: 34989706
DOI: 10.1097/PCC.0000000000002859 -
Pediatric Critical Care Medicine : a... Jan 2022To present consensus statements and supporting literature for plasma and platelet transfusions in critically ill children following noncardiac surgery and critically ill...
Plasma and Platelet Transfusion Strategies in Critically Ill Children Following Noncardiac Surgery and Critically Ill Children Undergoing Invasive Procedures Outside the Operating Room: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.
OBJECTIVES
To present consensus statements and supporting literature for plasma and platelet transfusions in critically ill children following noncardiac surgery and critically ill children undergoing invasive procedures outside the operating room from the Transfusion and Anemia EXpertise Initiative - Control/Avoidance of Bleeding.
DESIGN
Systematic review and consensus conference of international, multidisciplinary experts in platelet and plasma transfusion management of critically ill children.
SETTING
Not applicable.
PATIENTS
Critically ill children undergoing invasive procedures outside of the operating room or noncardiac surgery.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
A panel of 10 experts developed evidence-based and, when evidence was insufficient, expert-based statements for plasma and platelet transfusions in critically ill children following noncardiac surgery or undergoing invasive procedures outside of the operating room. These statements were reviewed and ratified by the 29 Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding experts. A systematic review was conducted using MEDLINE, EMBASE, and Cochrane Library databases, from inception to December 2020. Consensus was obtained using the Research and Development/University of California, Los Angeles Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed eight expert consensus statements focused on the critically ill child following noncardiac surgery and 10 expert consensus statements on the critically ill child undergoing invasive procedures outside the operating room.
CONCLUSIONS
Evidence regarding plasma and platelet transfusion in critically ill children in this area is very limited. The Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding Consensus Conference developed 18 pediatric specific consensus statements regarding plasma and platelet transfusion management in these critically ill pediatric populations.
Topics: Anemia; Blood Component Transfusion; Child; Critical Care; Critical Illness; Erythrocyte Transfusion; Evidence-Based Medicine; Hemorrhage; Humans; Operating Rooms; Plasma; Platelet Transfusion
PubMed: 34989705
DOI: 10.1097/PCC.0000000000002858 -
Pediatric Critical Care Medicine : a... Jan 2022To present the consensus statements with supporting literature for plasma and platelet transfusions in critically ill neonates and children with malignancy, acute liver...
Plasma and Platelet Transfusion Strategies in Critically Ill Children With Malignancy, Acute Liver Failure and/or Liver Transplantation, or Sepsis: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.
OBJECTIVES
To present the consensus statements with supporting literature for plasma and platelet transfusions in critically ill neonates and children with malignancy, acute liver disease and/or following liver transplantation, and sepsis and/or disseminated intravascular coagulation from the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding.
DESIGN
Systematic review and consensus conference of international, multidisciplinary experts in platelet and plasma transfusion management of critically ill children.
SETTING
Not applicable.
PATIENTS
Critically ill neonates and children with malignancy, acute liver disease and/or following liver transplantation, and sepsis and/or disseminated intravascular coagulation.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
A panel of 13 experts developed evidence-based and, when evidence was insufficient, expert-based statements for plasma and platelet transfusions in critically ill neonates and children with malignancy, acute liver disease and/or following liver transplantation, and sepsis and/or disseminated intravascular coagulation. These statements were reviewed and ratified by the 29 Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding experts. A systematic review was conducted using MEDLINE, EMBASE, and Cochrane Library databases, from inception to December 2020. Consensus was obtained using the Research and Development/University of California, Los Angeles Appropriateness Method. Results were summarized using the Grading of Recommendations Assessment, Development, and Evaluation method. We developed 12 expert consensus statements.
CONCLUSIONS
In the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding program, the current absence of evidence for use of plasma and/or platelet transfusion in critically ill children with malignancy, acute liver disease and/or following liver transplantation, and sepsis means that only expert consensus statements are possible for these areas of practice.
Topics: Anemia; Blood Component Transfusion; Child; Critical Care; Critical Illness; Disseminated Intravascular Coagulation; Erythrocyte Transfusion; Evidence-Based Medicine; Hemorrhage; Humans; Infant, Newborn; Liver Failure, Acute; Liver Transplantation; Neoplasms; Plasma; Platelet Transfusion; Sepsis
PubMed: 34989704
DOI: 10.1097/PCC.0000000000002857