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Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death.

ABSTRACT: The Platelets for Neonatal Thrombocytopenia (PlaNeT-2) trial reported an unexpected overall benefit of a prophylactic platelet transfusion threshold of 25 × 109/L compared with 50 × 109/L for major bleeding and/or mortality in preterm neonates (7% absolute-risk reduction). However, some neonates in the trial may have experienced little benefit or even harm from the 25 × 109/L threshold. We wanted to assess this heterogeneity of treatment effect in the PlaNet-2 trial, to investigate whether all preterm neonates benefit from the low threshold. We developed a multivariate logistic regression model in the PlaNet-2 data to predict baseline risk of major bleeding and/or mortality for all 653 neonates. We then ranked the neonates based on their predicted baseline risk and categorized them into 4 risk quartiles. Within these quartiles, we assessed absolute-risk difference between the 50 × 109/L- and 25 × 109/L-threshold groups. A total of 146 neonates died or developed major bleeding. The internally validated C-statistic of the model was 0.63 (95% confidence interval, 0.58-0.68). The 25 × 109/L threshold was associated with absolute-risk reduction in all risk groups, varying from 4.9% in the lowest risk group to 12.3% in the highest risk group. These results suggest that a 25 × 109/L prophylactic platelet count threshold can be adopted in all preterm neonates, irrespective of predicted baseline outcome risk. Future studies are needed to improve the predictive accuracy of the baseline risk model. This trial was registered at www.isrctn.com as #ISRCTN87736839.

SUBMITTER: Fustolo-Gunnink SF

PROVIDER: S-EPMC6933290 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death.

Fustolo-Gunnink Susanna F SF Fijnvandraat Karin K van Klaveren David D Stanworth Simon J SJ Curley Anna A Onland Wes W Steyerberg Ewout W EW de Kort Ellen E d'Haens Esther J EJ Hulzebos Christian V CV Huisman Elise J EJ de Boode Willem P WP Lopriore Enrico E van der Bom Johanna G JG

Blood 20191201 26

The Platelets for Neonatal Thrombocytopenia (PlaNeT-2) trial reported an unexpected overall benefit of a prophylactic platelet transfusion threshold of 25 × 109/L compared with 50 × 109/L for major bleeding and/or mortality in preterm neonates (7% absolute-risk reduction). However, some neonates in the trial may have experienced little benefit or even harm from the 25 × 109/L threshold. We wanted to assess this heterogeneity of treatment effect in the PlaNet-2 trial, to investigate whether all p ...[more]

PMID: 31697817

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Project description:IntroductionThrombocytopaenia is one of the most common haemostatic abnormalities among neonates. It affects approximately one-quarter of neonates admitted into neonatal intensive care units and may lead to a high risk of bleeding and mortality, which are substantial causes for concern by neonatologists. Platelet transfusion (PT) is a specific treatment for thrombocytopaenia. To date, PT thresholds are diverse since the associations between low platelet count and negative outcomes are not clear. We propose this protocol for a systematic review to collect and assess evidence concerning the best PT threshold to reduce mortality, bleeding and major morbidity among neonates with thrombocytopaenia.Methods and analysisThe systematic review will be performed according to the Cochrane Handbook for Systematic Review of Interventions, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, and the Grading of Recommendations Assessment, Development and Evaluation system. Two independent researchers will perform the study selection, data extraction/coding, quality assessment and further analyses of the included studies, with disagreements being resolved by a third researcher. A systematic search of the literature will be conducted in the PubMed, Cochrane Library and Embase databases from database inception through 13 October 2020. All randomised controlled trials, cohort studies and case-control studies will be included without any restrictions regarding publication date or language. The primary outcomes will comprise in-hospital mortality and bleeding episodes. Endnote X9 and Review Manager V.5.3 software will be used to manage the selection process and statistical analysis, respectively. If the included studies are sufficient and homogeneous for any of the outcomes, a quantitative synthesis (meta-analysis) may be performed. Otherwise, we will conduct a narrative systematic review of the results.Ethics and disseminationEthical approval is not required for this study because the data will be obtained from published studies and will not include individual patient data. The results of this study are anticipated to be published in a peer-reviewed journal.Prospero registration numberCRD42020169262.

Project description:To determine the association between prophylactic plasma transfusion and periprocedural red blood cell (RBC) transfusion rates in patients with elevated international normalized ratio (INR) values undergoing interventional radiology procedures.In this retrospective cohort study, adult patients undergoing interventional radiology procedures with a preprocedural INR available within 30 days of the procedure during a study period of January 1, 2009, to December 31, 2013, were eligible for inclusion. Baseline characteristics, coagulation parameters, transfusion requirements, and procedural details were extracted. Univariate and multivariable propensity-matched analyses were used to assess the relationships between prophylactic plasma transfusion and the outcomes of interest, with a primary outcome assessed a priori of RBC transfusion occurring during the procedure or within the first 24 hours postprocedurally.A total of 18,204 study participants met inclusion criteria for this study, and 1803 (9.9%) had an INR of 1.5 or greater before their procedure. Of these 1803 patients, 196 patients (10.9%) received prophylactic plasma transfusion with a median time of 1.9 hours (interquartile range [IQR], 1.1-3.2 hours) between plasma transfusion initiation and procedure initiation. In multivariable propensity-matched analysis, plasma administration was associated with increased periprocedural RBC transfusions (odds ratio, 2.20; 95% CI, 1.38-3.50; P<.001) and postprocedural intensive care unit admission rates (odds ratio, 2.11; 95% CI, 1.41-3.14; P<.001) as compared with those who were not transfused preprocedurally. Similar relationships were seen at higher INR thresholds for plasma transfusion.In patients undergoing interventional radiology procedures, preprocedural plasma transfusions given in the setting of elevated INR values were associated with increased periprocedural RBC transfusions. Additional research is needed to clarify this potential association between preprocedural plasma transfusion and periprocedural RBC transfusion.

Project description:Systematic review and meta-analyses of randomized controlled trials (RCTs) show that probiotics reduce the risk of necrotizing enterocolitis (NEC ≥ Stage II), late onset sepsis (LOS), all-cause mortality, and feeding intolerance in preterm neonates. Data from observational studies is important to confirm probiotic effects in clinical practice. We aimed to compare outcomes before and after implementing routine probiotic supplementation (RPS) in preterm neonates (<37 weeks of gestation) by performing a systematic review of non-RCTs using Cochrane methodology. Databases including PubMed, The Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Cochrane Central library, and Google Scholar were searched in May 2020. A meta-analysis was performed using a random effects model. Categorical measure of effect size was expressed as OR and 95% CI. Statistical heterogeneity was assessed by the chi-squared test, I2 statistic. The level of evidence (LOE) was summarized using GRADE (Grading of Recommendations Assessment, Development, and Evaluation) guidelines. Primary outcomes were NEC ≥ Stage II, LOS, and all-cause mortality. Secondary outcomes included probiotic sepsis. Thirty good-quality non-RCTs (n = 77,018) from 18 countries were included. The meta-analysis showed RPS was associated with significantly reduced: 1) NEC ≥ Stage II (30 studies, n = 77,018; OR: 0.60; 95% CI: 0.50, 0.73; P <0.00001, I2: 65%; LOE: Moderate), 2) LOS: (21 studies, n = 65,858; OR: 0.85; 95% CI: 0.74, 0.97; P = 0.02, I2: 74%; LOE: Low), and 3) all-cause mortality (27 non-RCTs, n = 70,977; OR: 0.77; 95% CI: 0.68, 0.88; P = 0.0001, I2: 49%; LOE: Low). Subgroups: 1) extremely low birth weight (ELBW: birth weight <1000 g) neonates: RPS was associated with significantly reduced NEC ≥ Stage II (4.5% compared with 7.9%). However, there was no difference in LOS and mortality. 2) Multistrain RPS was more effective than single strain. One study reported 3 nonfatal cases of probiotic sepsis. In summary, moderate- to low-quality evidence indicates that RPS was associated with significantly reduced NEC ≥ Stage II, LOS, and all-cause mortality in neonates <37 weeks of gestation and NEC ≥ Stage II in ELBW neonates.

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Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death.

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Preterm neonates benefit from low prophylactic platelet transfusion threshold despite varying risk of bleeding or death.

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