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The Cochrane Database of Systematic... Oct 2023Outcome after acute spontaneous (non-traumatic) intracerebral haemorrhage (ICH) is influenced by haematoma volume. ICH expansion occurs in about 20% of people with acute... (Review)
Review
BACKGROUND
Outcome after acute spontaneous (non-traumatic) intracerebral haemorrhage (ICH) is influenced by haematoma volume. ICH expansion occurs in about 20% of people with acute ICH. Early haemostatic therapy might improve outcome by limiting ICH expansion. This is an update of a Cochrane Review first published in 2006, and last updated in 2018.
OBJECTIVES
To examine 1. the effects of individual classes of haemostatic therapies, compared with placebo or open control, in adults with acute spontaneous ICH, and 2. the effects of each class of haemostatic therapy according to the use and type of antithrombotic drug before ICH onset.
SEARCH METHODS
We searched the Cochrane Stroke Trials Register, CENTRAL (2022, Issue 8), MEDLINE Ovid, and Embase Ovid on 12 September 2022. To identify further published, ongoing, and unpublished randomised controlled trials (RCTs), we scanned bibliographies of relevant articles and searched international registers of RCTs in September 2022.
SELECTION CRITERIA
We included RCTs of any haemostatic intervention (i.e. procoagulant treatments such as clotting factor concentrates, antifibrinolytic drugs, platelet transfusion, or agents to reverse the action of antithrombotic drugs) for acute spontaneous ICH, compared with placebo, open control, or an active comparator.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcome was death/dependence (modified Rankin Scale (mRS) 4 to 6) by day 90. Secondary outcomes were ICH expansion on brain imaging after 24 hours, all serious adverse events, thromboembolic adverse events, death from any cause, quality of life, mood, cognitive function, Barthel Index score, and death or dependence measured on the Extended Glasgow Outcome Scale by day 90.
MAIN RESULTS
We included 20 RCTs involving 4652 participants: nine RCTs of recombinant activated factor VII (rFVIIa) versus placebo/open control (1549 participants), eight RCTs of antifibrinolytic drugs versus placebo/open control (2866 participants), one RCT of platelet transfusion versus open control (190 participants), and two RCTs of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) (47 participants). Four (20%) RCTs were at low risk of bias in all criteria. For rFVIIa versus placebo/open control for spontaneous ICH with or without surgery there was little to no difference in death/dependence by day 90 (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.05; 7 RCTs, 1454 participants; low-certainty evidence). We found little to no difference in ICH expansion between groups (RR 0.81, 95% CI 0.56 to 1.16; 4 RCTs, 220 participants; low-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 0.81, 95% CI 0.30 to 2.22; 2 RCTs, 87 participants; very low-certainty evidence; death from any cause: RR 0.78, 95% CI 0.56 to 1.08; 8 RCTs, 1544 participants; moderate-certainty evidence). For antifibrinolytic drugs versus placebo/open control for spontaneous ICH, there was no difference in death/dependence by day 90 (RR 1.00, 95% CI 0.93 to 1.07; 5 RCTs, 2683 participants; high-certainty evidence). We found a slight reduction in ICH expansion with antifibrinolytic drugs for spontaneous ICH compared to placebo/open control (RR 0.86, 95% CI 0.76 to 0.96; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.02, 95% CI 0.75 to 1.39; 4 RCTs, 2599 participants; high-certainty evidence; death from any cause: RR 1.02, 95% CI 0.89 to 1.18; 8 RCTs, 2866 participants; high-certainty evidence). There was little to no difference in quality of life, mood, or cognitive function (quality of life: mean difference (MD) 0, 95% CI -0.03 to 0.03; 2 RCTs, 2349 participants; mood: MD 0.30, 95% CI -1.98 to 2.57; 2 RCTs, 2349 participants; cognitive function: MD -0.37, 95% CI -1.40 to 0.66; 1 RCTs, 2325 participants; all high-certainty evidence). Platelet transfusion likely increases death/dependence by day 90 compared to open control for antiplatelet-associated ICH (RR 1.29, 95% CI 1.04 to 1.61; 1 RCT, 190 participants; moderate-certainty evidence). We found little to no difference in ICH expansion between groups (RR 1.32, 95% CI 0.91 to 1.92; 1 RCT, 153 participants; moderate-certainty evidence). There was little to no difference in all serious adverse events and death from any cause between groups (all serious adverse events: RR 1.46, 95% CI 0.98 to 2.16; 1 RCT, 190 participants; death from any cause: RR 1.42, 95% CI 0.88 to 2.28; 1 RCT, 190 participants; both moderate-certainty evidence). For PCC versus FFP for anticoagulant-associated ICH, the evidence was very uncertain about the effect on death/dependence by day 90, ICH expansion, all serious adverse events, and death from any cause between groups (death/dependence by day 90: RR 1.21, 95% CI 0.76 to 1.90; 1 RCT, 37 participants; ICH expansion: RR 0.54, 95% CI 0.23 to 1.22; 1 RCT, 36 participants; all serious adverse events: RR 0.27, 95% CI 0.02 to 3.74; 1 RCT, 5 participants; death from any cause: RR 0.49, 95% CI 0.16 to 1.56; 2 RCTs, 42 participants; all very low-certainty evidence).
AUTHORS' CONCLUSIONS
In this updated Cochrane Review including 20 RCTs involving 4652 participants, rFVIIa likely results in little to no difference in reducing death or dependence after spontaneous ICH with or without surgery; antifibrinolytic drugs result in little to no difference in reducing death or dependence after spontaneous ICH, but result in a slight reduction in ICH expansion within 24 hours; platelet transfusion likely increases death or dependence after antiplatelet-associated ICH; and the evidence is very uncertain about the effect of PCC compared to FFP on death or dependence after anticoagulant-associated ICH. Thirteen RCTs are ongoing and are likely to increase the certainty of the estimates of treatment effect.
Topics: Adult; Humans; Hemostatics; Antifibrinolytic Agents; Fibrinolytic Agents; Cerebral Hemorrhage; Stroke; Anticoagulants
PubMed: 37870112
DOI: 10.1002/14651858.CD005951.pub5 -
European Journal of Haematology Oct 2023This study aimed to describe the burden of thrombocytopenia, supportive care practices, bleeding complications and predictors of bleeding in MDS patients within a large...
OBJECTIVES
This study aimed to describe the burden of thrombocytopenia, supportive care practices, bleeding complications and predictors of bleeding in MDS patients within a large Australian hospital network, to better understand the use and effectiveness of platelet transfusions in MDS.
METHODS
A retrospective cohort study of patients aged ≥18 years with MDS, chronic myelomonocytic leukaemia or MDS/myeloproliferative overlap neoplasm admitted from 2016 to 2018 was conducted. Data were obtained from hospital medical records.
RESULTS
One hundred seventy-nine patients (median age 78 years, 61.5% male) were identified. The median platelet count at first admission was 90 × 10 /L. Twenty-eight (15.6%) patients had severe thrombocytopenia (platelet count <20 × 10 /L), of whom nine (32.1%) received prophylactic platelet transfusions, five (17.9%) received tranexamic acid (TXA), seven (25%) received both platelet transfusions and TXA, and seven (25%) received no treatment. Bleeding events requiring hospitalisation occurred in 20 (11.2%) patients. Bleeding was not predicted by presenting platelet count, TXA use, platelet transfusion or anticoagulant/antiplatelet therapies. Three patients died of bleeding, at varying platelet counts (18, 38 and 153 × 10 /L).
CONCLUSION
Thrombocytopenia is common in MDS. Although guidelines recommend otherwise, prophylactic platelet transfusions were commonly used for severe thrombocytopenia. Despite the majority of patients receiving platelet transfusions and/or TXA, 11% developed major bleeding occurring at a wide range of platelet counts.
Topics: Humans; Male; Adolescent; Adult; Aged; Female; Platelet Transfusion; Retrospective Studies; Australia; Hemorrhage; Myelodysplastic Syndromes; Thrombocytopenia; Tranexamic Acid
PubMed: 37452616
DOI: 10.1111/ejh.14049 -
Anesthesiology Sep 2023Centrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France)...
Combined Platelet and Red Blood Cell Recovery during On-pump Cardiac Surgery Using same™ by i-SEP Autotransfusion Device: A First-in-human Noncomparative Study (i-TRANSEP Study).
BACKGROUND
Centrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets. The authors tested the hypothesis that this new device could allow a red blood cell recovery exceeding 80% with a posttreatment hematocrit exceeding 40%, and would remove more than 90% of heparin and 75% of free hemoglobin.
METHODS
Adults undergoing on-pump elective cardiac surgery were included in a noncomparative multicenter trial. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. The primary outcome was a composite of cell recovery performance, assessed in the device by red blood cell recovery and posttreatment hematocrit, and of biologic safety assessed in the device by the washout of heparin and free hemoglobin expressed as removal ratios. Secondary outcomes included platelet recovery and function and adverse events (clinical and device-related adverse events) up to 30 days after surgery.
RESULTS
The study included 50 patients, of whom 18 (35%) underwent isolated coronary artery bypass graft, 26 (52%) valve surgery, and 6 (12%) aortic root surgery. The median red blood cell recovery per cycle was 86.1% (25th percentile to 75th percentile interquartile range, 80.8 to 91.6) with posttreatment hematocrit of 41.8% (39.7 to 44.2). Removal ratios for heparin and free hemoglobin were 98.9% (98.2 to 99.7) and 94.6% (92.7 to 96.6), respectively. No adverse device effect was reported. Median platelet recovery was 52.4% (44.2 to 60.1), with a posttreatment concentration of 116 (93 to 146) · 109/l. Platelet activation state and function, evaluated by flow cytometry, were found to be unaltered by the device.
CONCLUSIONS
In this first-in-human study, the same™ device was able to simultaneously recover and wash both platelets and red blood cells. Compared with preclinical evaluations, the device achieved a higher platelet recovery of 52% with minimal platelet activation while maintaining platelet ability to be activated in vitro.
Topics: Adult; Humans; Blood Transfusion, Autologous; Blood Platelets; Erythrocytes; Cardiac Surgical Procedures; Hemoglobins; Heparin
PubMed: 37294939
DOI: 10.1097/ALN.0000000000004642 -
Transfusion and Apheresis Science :... Aug 2023
Topics: Humans; Platelet Transfusion; Thrombocytopenia; Hemorrhage; Blood Platelets
PubMed: 37059653
DOI: 10.1016/j.transci.2023.103711 -
Journal of Cardiothoracic and Vascular... Dec 2023This is an annual review to cover highlights in transfusion and coagulation in patients undergoing cardiovascular surgery. The goal of this article is to provide readers...
This is an annual review to cover highlights in transfusion and coagulation in patients undergoing cardiovascular surgery. The goal of this article is to provide readers with a focused summary of the most important transfusion and coagulation topics published in 2022. This includes a discussion covering the management of anemia and red blood cell transfusion, the management of factor Xa inhibitors, updates in coagulation testing, updates in the use of factor concentrates, advances in platelet therapy, advances in anticoagulation management of patients on extracorporeal membrane oxygenation and other forms of mechanical circulatory support, and advances in the diagnosis and management of heparin-induced thrombocytopenia.
Topics: Humans; Blood Coagulation; Blood Transfusion; Blood Coagulation Tests; Thrombocytopenia; Blood Platelets; Heparin; Anticoagulants
PubMed: 37690951
DOI: 10.1053/j.jvca.2023.08.132 -
Platelets Dec 2023The hybrid-channel platelet counting method (PLT-H) is a new platelet counting technique proposed by Mindray of China. In this study, we aimed to evaluate the accuracy...
The hybrid-channel platelet counting method (PLT-H) is a new platelet counting technique proposed by Mindray of China. In this study, we aimed to evaluate the accuracy of this technique in various situations and its reliability in platelet transfusion decision-making. A total of 378 venous blood samples were tested. Using the immunological PLT counting method recommended by the International Council for Standardization in Hematology as the reference method (PLT-IRM), Passing-Bablok regression and Bland-Altman analysis were performed on the PLT-H results. The anti-interference performance of PLT-H under different interference levels was explored using intergroup comparisons, and confusion matrices were analyzed at various transfusion cutoff values. In the absence of interference, there was a strong correlation between PLT-H and PLT-IRM ( = 0.993, 95% CI: 0.990-0.996). Under various interference conditions, the correlation between PLT-H and PLT-IRM was between 0.963 and 0.992, with an average deviation of -14.56 to -2.02. The performance of PLT-H against interference did not change significantly with increasing levels of small RBCs, large PLTs, and RBC fragments ( = .5704, 0.0832, 0.9893). In low-value samples (PLT <100 × 10/L), the coefficient of variation (CV) for PLT-H was less than 7.6%, regardless of the presence or absence of interfering substances. In addition, there was a high agreement between PLT-H and PLT-IRM (ICC = 0.972). Confusion matrice analysis at each medical decision level showed similarity to methods using the fluorescence channel (PLT-O) and superiority to the impedance channel (PLT-I). Compared with PLT-I, PLT-H has higher accuracy in PLT counting, stronger anti-interference ability, better performance in low-value samples at no extra economic cost and can be more useful for platelet transfusion decision-making. PLT-H is a novel method for platelet counting that offers higher accuracy, providing physicians with the ability to make better medical decisions, particularly in cases where values are low, or interference is present. As it does not require additional reagents, it is highly likely to replace PLT-I and become the mainstream method for platelet counting in the future.
Topics: Humans; Platelet Transfusion; Reproducibility of Results; Blood Platelets; Platelet Count
PubMed: 38031975
DOI: 10.1080/09537104.2023.2287064 -
PharmacoEconomics - Open Sep 2023Evidence-based guidelines on platelet transfusion therapy assist clinicians to optimize patient care, but currently do not take into account costs associated with...
BACKGROUND AND OBJECTIVE
Evidence-based guidelines on platelet transfusion therapy assist clinicians to optimize patient care, but currently do not take into account costs associated with different methods used during the preparation, storage, selection and dosing of platelets for transfusion. This systematic review aimed to summarize the available literature regarding the cost effectiveness (CE) of these methods.
METHODS
Eight databases and registries, as well as 58 grey literature sources, were searched up to 29 October 2021 for full economic evaluations comparing the CE of methods for preparation, storage, selection and dosing of allogeneic platelets intended for transfusion in adults. Incremental CE ratios, expressed as standardized cost (in 2022 EUR) per quality-adjusted life-year (QALY) or per health outcome, were synthesized narratively. Studies were critically appraised using the Philips checklist.
RESULTS
Fifteen full economic evaluations were identified. Eight investigated the costs and health consequences (transfusion-related events, bacterial and viral infections or illnesses) of pathogen reduction. The estimated incremental cost per QALY varied widely from EUR 259,614 to EUR 36,688,323. For other methods, such as pathogen testing/culturing, use of apheresis instead of whole blood-derived platelets, and storage in platelet additive solution, evidence was sparse. Overall, the quality and applicability of the included studies was limited.
CONCLUSIONS
Our findings are of interest to decision makers who consider implementing pathogen reduction. For other preparation, storage, selection and dosing methods in platelet transfusion, CE remains unclear due to insufficient and outdated evaluations. Future high-quality research is needed to expand the evidence base and increase our confidence in the findings.
PubMed: 37365482
DOI: 10.1007/s41669-023-00427-w -
Journal of Clinical Oncology : Official... Aug 2023Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic... (Clinical Trial)
Clinical Trial
Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III Study.
PURPOSE
Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic transitional-cell carcinoma (TCC) of the urothelium.
PATIENTS AND METHODS
Patients with stage IV TCC and no prior systemic chemotherapy were randomized to GC (gemcitabine 1,000 mg/m days 1, 8, and 15; cisplatin 70 mg/m day 2) or standard MVAC every 28 days for a maximum of six cycles.
RESULTS
Four hundred five patients were randomized (GC, n = 203; MVAC, n = 202). The groups were well-balanced with respect to prognostic factors. Overall survival was similar on both arms (hazards ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; = .75), as were time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30), time to treatment failure (HR, 0.89; 95% CI, 0.72 to 1.10), and response rate (GC, 49%; MVAC, 46%). More GC patients completed six cycles of therapy, with fewer dose adjustments. The toxic death rate was 1% on the GC arm and 3% on the MVAC arm. More GC than MVAC patients had grade 3/4 anemia (27% 18%, respectively) and thrombocytopenia (57% 21%, respectively). On both arms, the RBC transfusion rate was 13 of 100 cycles and grade 3/4 hemorrhage or hematuria was 2%; the platelet transfusion rate was four patients per 100 cycles and two patients per 100 cycles on GC and MVAC, respectively. More MVAC patients, compared with GC patients, had grade 3/4 neutropenia (82% 71%, respectively), neutropenic fever (14% 2%, respectively), neutropenic sepsis (12% 1%, respectively), and grade 3/4 mucositis (22% 1%, respectively) and alopecia (55% 11%, respectively). Quality of life was maintained during treatment on both arms; however, more patients on GC fared better regarding weight, performance status, and fatigue.
CONCLUSION
GC provides a similar survival advantage to MVAC with a better safety profile and tolerability. This better-risk benefit ratio should change the standard of care for patients with locally advanced and metastatic TCC from MVAC to GC.
PubMed: 37549482
DOI: 10.1200/JCO.22.02763 -
Clinical Laboratory Aug 2023This study was to store the expression and clinical significance of circRNA changes in red blood cells during platelet transfusion in acute lymphoblastic leukemia (ALL).
BACKGROUND
This study was to store the expression and clinical significance of circRNA changes in red blood cells during platelet transfusion in acute lymphoblastic leukemia (ALL).
METHODS
Sixty patients with ALL who underwent platelet transfusion were enrolled. Post-transfusion symptoms, platelet count (PLT), 24-hour corrected platelet increase index (CCI), and 24-hour platelet recovery rate (PPR) were collected, and their correlation with age, gender, bleeding, infection, splenomegaly, antibiotic use and infusion times were analyzed. High-throughput sequencing was used to detect the expression levels of circRNAs in suspended red blood cells of the blood samples. Then, the circRNA expression profiles were constructed, the differentially expressed circRNAs were screened, and the circRNAs related to platelet transfusion in AML were mined.
RESULTS
PLT values of 60 ALL patients after platelet transfusion were significantly increased. Thirty-five patients were effective and 25 were ineffective after platelet transfusion, and the total effective rate was 58.33%. Patients with hemorrhage and splenomegaly, or antibiotic use, or increased blood transfusion frequency will show reduced efficacy of platelet transfusion. A total of 2,358 circRNAs were obtained from all samples, most of which were distributed in 200 - 3,000 nt. circRNAs can be divided into exonic circRNAs (58.74%), sense overlapping circRNAs (21.76%), intronic circRNAs (17.60%), antisense circRNAs (0.93%), and intergenic circRNAs (0.98%). A total of 257 differentially expressed circRNAs were obtained by volcano plot analysis, of which 126 were up-regulated and 131 were down-regulated. Differentially up-regulated and down-regulated circRNAs were mainly enriched in dif-ferent cellular processes.
CONCLUSIONS
ALL is improved after platelet transfusion. By constructing circRNA expression profiles and screening differentially expressed circRNAs, 257 circRNAs that may be related to ALL platelet transfusion were mined.
Topics: Humans; RNA, Circular; RNA; Platelet Transfusion; Clinical Relevance; Splenomegaly; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Ifosfamide; Etoposide; MicroRNAs
PubMed: 37560876
DOI: 10.7754/Clin.Lab.2023.221103 -
Transfusion and Apheresis Science :... Jun 2024While there are various aspects of platelet biology that can be studied in the lab (i.e. adhesion, degranulation, integrin activation), the master test for platelet... (Review)
Review
While there are various aspects of platelet biology that can be studied in the lab (i.e. adhesion, degranulation, integrin activation), the master test for platelet function is that which gives a measure of the platelet aggregation capacity upon stimulation with an agonist. Platelet function testing is necessary for the diagnosis of platelet disorders and the monitoring of patients receiving anti-platelet treatments. Furthermore, it becomes relevant in the quality control of platelet concentrates for transfusion purposes, especially considering the global concern about long term storage, other forms of storage (i.e. cryopreservation, lyophilization), and the impact of Pathogen Reduction Treatments (PRTs) on platelet performance upon transfusion. However, it has been acknowledged as technically difficult and demanding, since a fine platelet function test must be carried out under specific conditions. Still, there might be occasions that preclude the platelet function testing abiding to the gold standard requirements, thus, leaving us with the necessity to redefine which variables may condition or limit the analysis of platelet function testing. In the present manuscript, we test different variables (such as the anticoagulant used or the time elapsed since extraction) and the possibility to reconstitute blood prior to platelet function analysis. This study aims to provide windows of action at the diagnostics lab, especially when not all of the recommended procedures and conditions can be followed: for example, when a sample is sent from a long distance, when there is a limitation on blood extraction volume or when certain parameters (platelet count) preclude reliable test results.
Topics: Humans; Platelet Function Tests; Platelet Count; Blood Platelets
PubMed: 38644062
DOI: 10.1016/j.transci.2024.103930