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Reference Library HomeThe Premature Infants in Need of Transfusion (Pint) Study: A Randomized, Controlled Trial of a Restrictive (LOW) Versus Liberal (HIGH) Transfusion Threshold for Extremely Low Birth Weight Infants
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Date Posted: Monday, October 2nd, 2006
| Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, Lacorte M, Connelly R, Barrington K, Roberts RS; PINT Investigators. J Pediatr. 2006 Sep;149(3):301-307.e3 | |
| Abstract Here | |
| Summary | |
| This multicenter randomized controlled trial found no indication of harm from a restrictive transfusion threshold in acutely ill extremely low birth weigh infants. 10 international centers participated in this trial comparing clinical outcomes in 451 extremely low birth weight infants (<1000 g) randomly assigned during the first two days of life to either a restrictive (low) or a liberal (high) transfusion threshold algorithm. Hemoglobin level transfusion thresholds varied according to age and level of respiratory support needed. Clinicians were permitted to administer “clinically driven” transfusions outside the algorithm. The primary outcome was a composite of death or survival with morbidities (retinopathy, bronchopulmonary dysplasia or brain injury [as measured by ultrasound]). Secondary outcomes included hemoglobin level, number of red blood cell (RBC) transfusions, number of donor exposures, rate of growth, necrotizing enterocolitis, apnea, infections, time on oxygen, time to extubation, and hospital length of stay. Result: 11% of the restrictive group avoided transfusions altogether compared with 5% in the liberal group (P=.037). There was a non-significant decrease in the number or RBC transfusions in the restrictive group compared with the liberal group (mean 4.9 units vs 5.7 units respectively). The restrictive group had significantly less RBC donor exposures compared with the liberal group (P=.035). When all blood products transfused were considered (including platelets and plasma), there was no statistically significant reduction in donor exposures. The investigators found no significant differences in primary or secondary outcome morbidities. The accompanying editorial (Bell EF) is by the lead author of an earlier, smaller randomized controlled trial (Bell et al) that found an indication of some harm associated with a restrictive transfusion threshold. In that trial, infants in the restrictive transfusion group were more likely to suffer parenchymal brain hemorrhage, periventricular leukomacia and more frequent apnea than infants in the liberal transfusion group. The current trial, however, found no such differences. | |
| Expert Summary
Kirpalanai and colleagues recently published the above study which sought to determine whether extremely low birth weight infants (ELBW) transfused at lower hemoglobin thresholds versus higher thresholds have different rates of survival or morbidity at discharge. This large, multicenter randomized clinical trial was designed to examine the impact of transfusion strategy on the incidence of a composite outcome—death, retinopathy of prematurity, bronchopulmonary dysplasia, or abnormal brain ultrasound—in ELBW infants. 451 ELBW infants were randomized to one of two transfusion strategies defined by the hemoglobin thresholds for RBC transfusion. The thresholds varied with age and with the level of respiratory support needed. There were no baseline differences between the 223 infants randomized to the low transfusion threshold and the 228 infants randomized to the high transfusion threshold. The average birth weight of study participants was 770 grams. Differences in hematocrit between groups were achieved by the first week of study. The composite primary outcome was similar for both groups: 74% in the low group, 70% in the high group (p=0.25). In particular, the incidence of brain injury determined by ultrasound was 12.6% in the low group and 16% in the high group (p=0.53). The authors concluded that, “In ELBW infants, maintaining a higher hemoglobin results in more infants receiving transfusions but confers little evidence of benefit.” The PINT study investigators are to be commended for their insightful, well designed study. Because the study by Bell et al was published prior to the PINT study, controversy still exists regarding the benefits and risks of restrictive transfusion guidelines. Both of these studies measured what infants received, rather than what they actually needed. Neonatal transfusion practices would greatly benefit from studies that generate transfusion guidelines based on need, by identifying a useful transfusion marker. This work remains to be accomplished. Robin Ohls, MD |
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