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Annals of Hematology Oct 2022Thrombocytopenia is a common and unsolved problem in myelodysplastic syndrome (MDS) patients; we aimed to summarize the evidence of TPO-RA treatment for heath-related... (Meta-Analysis)
Meta-Analysis
Effect of thrombopoietin receptor agonist on health-related quality of life and platelet transfusion burden for patients with myelodysplastic syndromes: a systematic review and meta-analysis.
Thrombocytopenia is a common and unsolved problem in myelodysplastic syndrome (MDS) patients; we aimed to summarize the evidence of TPO-RA treatment for heath-related quality of life (HRQoL) and platelet transfusion burden of MDS patients. We searched Pubmed, Web of Science, EMBASE, and CENTRAL for randomized clinical trials (RCTs) comparing TPO-RA to placebo in MDS published until July 31, 2021. A random-effect model was used. Eight RCTs with 908 patients were identified. Only three RCTs involving eltrombopag reported HRQoL, and all three studies treated HRQoL as a secondary outcome. In these three RCTs, the HRQoL instruments used in each study were different. However, this outcome cannot be meta-analyzed because some studies did not provide complete data. Subsequent clinical trials should pay more attention to this. Compared to placebo, TPO-RA did not affect platelet transfusion incidence 0.83 (95% CI 0.60-1.15). There was no evidence for subgroup differences in the analyses of different types of TPO-RA, different additional agent, and different types of MDS risk groups. However, platelet transfusion units (RR = 0.68, 95% CI 0.53 to 0.84) were significantly decreased. The RR of patients who did not require platelet transfusion for 56 or more consecutive days was not different between groups (RR = 0.98, 95% CI 0.41 to 2.34). TPO-RA may decrease platelet transfusion units in MDS patients with thrombocytopenia. But the significance of this finding should be interpreted with caution, because too few studies were meta-analyzed.
Topics: Hematologic Agents; Humans; Myelodysplastic Syndromes; Platelet Transfusion; Quality of Life; Receptors, Thrombopoietin; Recombinant Fusion Proteins; Thrombocytopenia; Thrombopoietin
PubMed: 35976414
DOI: 10.1007/s00277-022-04950-4 -
Blood Coagulation & Fibrinolysis : An... Oct 2022Thrombocytopenia and bleeding are common complications of hematologic malignancies. Often, prophylactic platelets are administered to minimize bleeding risk, based on... (Meta-Analysis)
Meta-Analysis
Thrombocytopenia and bleeding are common complications of hematologic malignancies. Often, prophylactic platelets are administered to minimize bleeding risk, based on total platelet count (TPC). However, TPC is a poor predictor, and does not provide rapid information. This review presents a novel prospective in the use of point-of-care viscoelastic studies to assess bleeding risk and guide transfusion therapy in a haematological oncological population, where its use can be extended to a ward level as a bedside test. Monitoring TEG maximum amplitude trends may be useful to guide transfusion protocols, especially for patients with total platelet counts ranging 30-100 × 10 9 /l. Fibrinogen assessment in this group of patients may identify other blood components that require replacing to reduce bleeding risk. Normal maximum amplitude parameters for patients with low platelet counts can be a reassuring sign. This meta-analysis serves to remind the reader that absolute platelet quantity does not equate to the quality of clot formation.
Topics: Fibrinogen; Hematologic Neoplasms; Hematology; Hemorrhage; Humans; Platelet Transfusion; Prospective Studies; Thrombelastography
PubMed: 35946467
DOI: 10.1097/MBC.0000000000001141 -
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 -
The Journal of Vascular Access Jul 2022Insertion of venous access devices (VAD) is usually considered a procedure with low risk of bleeding. Nonetheless, insertion of some devices is invasive enough to be...
Insertion of venous access devices (VAD) is usually considered a procedure with low risk of bleeding. Nonetheless, insertion of some devices is invasive enough to be associated with bleeding, especially in patients with previous coagulopathy or in treatment with antithrombotic drugs for cardiovascular disease. The current practices of platelet/plasma transfusion in coagulopathic patients and of temporary suspension of the antithrombotic treatment before VAD insertion are based on local policies and are often inadequately supported by evidence, since many of the clinical studies on this topic are not recent and are not of high quality. Furthermore, the protocols of antithrombotic treatment have changed during the last decade, after the introduction of new oral anticoagulant drugs. Though some guidelines address some of these issues in relation with specific procedures (port insertion, etc.), no evidence-based document covering all the aspects of this clinical problem is currently available. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to develop a consensus on the management of antithrombotic treatment and bleeding disorders in patients requiring VADs. After a systematic review of the available evidence, the panel of the consensus (which included vascular access specialists, surgeons, intensivists, anesthetists, cardiologists, vascular medicine experts, nephrologists, infective disease specialists, and thrombotic disease specialists) has structured the final recommendations as detailed answers to three sets of questions: (1) which is an appropriate classification of VAD-related procedures based on the specific bleeding risk? (2) Which is the appropriate management of the patient with bleeding disorders candidate to VAD insertion/removal? (3) Which is the appropriate management of the patient on antithrombotic treatment candidate to VAD insertion/removal? Only statements reaching a complete agreement were included in the final recommendations, and all recommendations were offered in a clear and synthetic list, so to be easily translated into clinical practice.
Topics: Anticoagulants; Blood Component Transfusion; Fibrinolytic Agents; Hemorrhage; Humans; Plasma
PubMed: 35533088
DOI: 10.1177/11297298211072407 -
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 -
Clinical Transplantation Oct 2022Liver transplantation (LT) is frequently complicated by coagulopathy associated with end-stage liver disease (ESLD), that is, often multifactorial. (Review)
Review
Intraoperative transfusion management, antifibrinolytic therapy, coagulation monitoring and the impact on short-term outcomes after liver transplantation-A systematic review of the literature and expert panel recommendations.
BACKGROUND
Liver transplantation (LT) is frequently complicated by coagulopathy associated with end-stage liver disease (ESLD), that is, often multifactorial.
OBJECTIVES
The objective of this systematic review was to identify evidence based intraoperative transfusion and coagulation management strategies that improve immediate and short-term outcomes after LT.
METHODS
PRISMA-guidelines and GRADE-approach were followed. Three subquestions were formulated. (Q); Q1: transfusion management; Q2: antifibrinolytic therapy; and Q3: coagulation monitoring.
RESULTS
Sixteen studies were included for Q1, six for Q2, and 10 for Q3. Q1: PRBC and platelet transfusions were associated with higher mortality. The use of prothrombin complex concentrate (PCC) and fibrinogen concentrate (FC) were not associated with reductions in intraoperative transfusion or increased thrombotic events. The use of cell salvage was not associated with hepatocellular carcinoma (HCC) recurrence or mortality. Cell salvage and transfusion education significantly decreased blood product transfusions. Q2: Epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) were not associated with decreased blood product transfusion, improvements in patient or graft survival, or increases in thrombotic events. Q3: Viscoelastic testing (VET) was associated with decreased allogeneic blood product transfusion compared to conventional coagulation tests (CCT) and is likely to be cost-effective. Coagulation management guided by VET may be associated with increases in FC and PCC use.
CONCLUSION
Q1: A specific blood product transfusion practice is not recommended (QOE; low | Recommendation; weak). Cell salvage and educational interventions are recommended (QOE: low | Grade of Recommendation: moderate). Q2: The routine use of antifibrinolytics is not recommended (QOE; low | Recommendation; weak). Q3: The use of VET is recommended (QOE; low-moderate | Recommendation; strong).
Topics: Humans; Antifibrinolytic Agents; Liver Transplantation; Carcinoma, Hepatocellular; Liver Neoplasms; Blood Transfusion; Thrombelastography
PubMed: 35249250
DOI: 10.1111/ctr.14637 -
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