Dataset Information

Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.

ABSTRACT:

Background

Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia.

Methods

We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity.

Results

A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively.

Conclusions

In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).

SUBMITTER: Kirpalani H

PROVIDER: S-EPMC8487591 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.

Kirpalani Haresh H Bell Edward F EF Hintz Susan R SR Tan Sylvia S Schmidt Barbara B Chaudhary Aasma S AS Johnson Karen J KJ Crawford Margaret M MM Newman Jamie E JE Vohr Betty R BR Carlo Waldemar A WA D'Angio Carl T CT Kennedy Kathleen A KA Ohls Robin K RK Poindexter Brenda B BB Schibler Kurt K Whyte Robin K RK Widness John A JA Zupancic John A F JAF Wyckoff Myra H MH Truog William E WE Walsh Michele C MC Chock Valerie Y VY Laptook Abbot R AR Sokol Gregory M GM Yoder Bradley A BA Patel Ravi M RM Cotten C Michael CM Carmen Melissa F MF Devaskar Uday U Chawla Sanjay S Seabrook Ruth R Higgins Rosemary D RD Das Abhik A

The New England journal of medicine 20201201 27

<h4>Background</h4>Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia.<h4>Methods</h4>We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds unt ...[more]

PMID: 33382931

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Project description:BackgroundEfficacy and safety of different hemoglobin thresholds for transfusion of red blood cells (RBCs) in adults with an acute respiratory distress syndrome (ARDS) are unknown. We therefore assessed the effect of two transfusion thresholds on short-term outcome in patients with ARDS.MethodsPatients who received transfusions of RBCs were identified from a cohort of 1044 ARDS patients. After propensity score matching, patients transfused at a hemoglobin concentration of 8 g/dl or less (lower-threshold) were compared to patients transfused at a hemoglobin concentration of 10 g/dl or less (higher-threshold). The primary endpoint was 28-day mortality. Secondary endpoints included ECMO-free, ventilator-free, sedation-free, and organ dysfunction-free composites.Measurements and main resultsOne hundred ninety-two patients were eligible for analysis of the matched cohort. Patients in the lower-threshold group had similar baseline characteristics and hemoglobin levels at ARDS onset but received fewer RBC units and had lower hemoglobin levels compared with the higher-threshold group during the course on the ICU (9.1 [IQR, 8.7-9.7] vs. 10.4 [10-11] g/dl, P < 0.001). There was no difference in 28-day mortality between the lower-threshold group compared with the higher-threshold group (hazard ratio, 0.94 [95%-CI, 0.59-1.48], P = 0.78). Within 28 days, 36.5% (95%-CI, 27.0-46.9) of the patients in the lower-threshold group compared with 39.5% (29.9-50.1) of the patients in the higher-threshold group had died. While there were no differences in ECMO-free, sedation-free, and organ dysfunction-free composites, the chance for successful weaning from mechanical ventilation within 28 days after ARDS onset was lower in the lower-threshold group (subdistribution hazard ratio, 0.36 [95%-CI, 0.15-0.86], P = 0.02).ConclusionsTransfusion at a hemoglobin concentration of 8 g/dl, as compared with a hemoglobin concentration of 10 g/dl, was not associated with an increase in 28-day mortality in adults with ARDS. However, a transfusion at a hemoglobin concentration of 8 g/dl was associated with a lower chance for successful weaning from the ventilator during the first 28 days after ARDS onset.Trial registrationClinicalTrials.gov NCT03871166.

Project description:OBJECT There is limited literature available to guide transfusion practices for patients with severe traumatic brain injury (TBI). Recent studies have shown that maintaining a higher hemoglobin threshold after severe TBI offers no clinical benefit. The present study aimed to determine if a higher transfusion threshold was independently associated with an increased risk of progressive hemorrhagic injury (PHI), thereby contributing to higher rates of morbidity and mortality. METHODS The authors performed a secondary analysis of data obtained from a recently performed randomized clinical trial studying the effects of erythropoietin and blood transfusions on neurological recovery after severe TBI. Assigned hemoglobin thresholds (10 g/dl vs 7 g/dl) were maintained with packed red blood cell transfusions during the acute phase after injury. PHI was defined as the presence of new or enlarging intracranial hematomas on CT as long as 10 days after injury. A severe PHI was defined as an event that required an escalation of medical management or surgical intervention. Clinical and imaging parameters and transfusion thresholds were used in a multivariate Cox regression analysis to identify independent risk factors for PHI. RESULTS Among 200 patients enrolled in the trial, PHI was detected in 61 patients (30.5%). The majority of patients with PHI had a new, delayed contusion (n = 29) or an increase in contusion size (n = 15). The mean time interval between injury and identification of PHI was 17.2 ± 15.8 hours. The adjusted risk of severe PHI was 2.3 times higher for patients with a transfusion threshold of 10 g/dl (95% confidence interval 1.1-4.7; p = 0.02). Diffuse brain injury was associated with a lower risk of PHI events, whereas higher initial intracranial pressure increased the risk of PHI (p < 0.001). PHI was associated with a longer median length of stay in the intensive care unit (18.3 vs 14.4 days, respectively; p = 0.04) and poorer Glasgow Outcome Scale scores (42.9% vs 25.5%, respectively; p = 0.02) at 6 months. CONCLUSIONS A higher transfusion threshold of 10 g/dl after severe TBI increased the risk of severe PHI events. These results indicate the potential adverse effect of using a higher hemoglobin transfusion threshold after severe TBI.

Project description:The comparative efficacy and safety of restrictive with liberal transfusion thresholds remain controversial in anemic preterm infants. This meta-analysis aimed to compare the efficacy and safety of these two transfusion thresholds for anemic preterm infants. We searched PubMed, Embase, Cochrane Library, and China National Knowledge Infrastructure (CNKI) for relevant randomized controlled trials (RCTs) comparing restrictive with liberal transfusion thresholds in anemic preterm infants through April 30, 2022. Two independent investigators screened literature, extracted data, and appraised the methodological quality of eligible studies. Meta-analysis was conducted using RevMan version 5.3.5. Twelve RCTs with 4380 preterm infants were included. Liberal transfusion threshold significantly increased the level of hemoglobin after transfusion (mean difference (MD): -10.03; 95% confidence interval (CI): -15.98 to -4.08; p=0.001; I2=94%) and hematocrit (MD: -3.62; 95%CI: -6.78 to -0.46; p=0.02; I2=80%) compared with restrictive transfusion. Infants' age at first transfusion in restrictive transfusion group was higher than that of infants in liberal transfusion group (MD: 5.08; 95%CI: 2.27 to7.89; p=0.004; I2=54%); however, restrictive transfusion was associated with more time on supplemental oxygen (MD: 3.56; 95%CI: 1.93 to 5.18; p<0.001; I2=62%) and ventilator or CPAP (MD: 3.31; 95%CI: 1.42 to 5.20; p=0.006; I2=75%). For the remaining outcomes, two transfusion strategies were comparable. Furthermore, a series of sensitivity analyses confirmed the robustness of the level of hemoglobin after transfusion, age at first transfusion, time on ventilator or CPAP, and safety outcomes. Evidence with substantial heterogeneity indicates that liberal and restrictive transfusion thresholds are effective and safe blood cell transfusion strategies in anemic preterm infants, but the liberal strategy may be more effective in shortening the length of necessary respiratory support.

Project description:BackgroundIt is widely acceptable to involve parents in decision-making about the resuscitation of extremely preterm infants (EPIs) in the gray zone. However, there are different views about where the boundaries of the gray zone should lie. Our aim in this study was to compare the resuscitation thresholds for EPIs between neonatologists in the United Kingdom, Sweden, and the Netherlands.MethodsWe distributed an online survey to consultant neonatologists and neonatal registrars and fellows that included clinical scenarios in which parents requested resuscitation or nonresuscitation. Respondents were asked about the lowest gestational age and/or the worst prognosis at which they would provide resuscitation and the highest gestational age and/or the best prognosis at which they would withhold resuscitation. In additional scenarios, influence of the condition at birth or consideration of available health care resources was assessed.ResultsThe survey was completed by 162 neonatologists (30% response rate). There was a significant difference between countries; the gray zone for most UK respondents was 23 + 0/7 to 23 + 6/7 or 24 weeks' gestation, compared with 22 + 0/7 to 22 + 6/7 or 23 weeks' gestation in Sweden and 24 + 0/7 to 25 + 6/7 or 26 weeks' gestation in the Netherlands. Resuscitation thresholds were higher if an infant was born in poor condition. There was wide variation in the prognosis that warranted resuscitation or nonresuscitation. Consideration of resource scarcity did not alter responses.ConclusionsIn this survey, we found significant differences in approach to the resuscitation of EPIs, with a spectrum from most proactive (Sweden) to least proactive (Netherlands). Most survey respondents indicated shifts in decision-making that were associated with particular weeks' gestation. Despite the different approaches to decision-making in the 3 countries, there was relatively little difference between countries in neonatologists' prognostic thresholds for resuscitation.

Dataset Information

Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.

Background

Methods

Results

Conclusions

Publications

Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.

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