BACKGROUND
Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious, even fatal, adverse events. Patients undergoingcardiac surgery may be especially vulnerable to the adverse effects of transfusion.
METHODS
We conducted a randomized trial at multiple sites from 2010 to 2014. Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less (shorter-term storage group) or for 21 days or more (longer-term storage group) for all intraoperative and postoperative transfusions. The primary outcome was the change in Multiple Organ Dysfunction Score (MODS; range, 0 to 24, with higher scores indicating more severe organ dysfunction) from the preoperative score to the highest composite score through day 7 or the time of death or discharge.
RESULTS
The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group. The mean change in MODS was an increase of 8.5 and 8.7 points, respectively (95% confidence interval for the difference, −0.6 to 0.3; P = 0.44). The 7-day mortality was 2.8% in the shorter-term storage group and 2.0% in the longer-term storage group (P = 0.43); 28-day mortality was 4.4% and 5.3%, respectively (P = 0.57). Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group.
CONCLUSIONS
The duration of red-cell storage was not associated with significant differences in the change in MODS. We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery. (Funded by the National Heart, Lung, and Blood Institute; RECESS ClinicalTrials.gov number, NCT00991341.)
The proposed UDPB in adult cardiac surgery provides a precise classification of bleeding that is useful in everyday practice as well as in clinical research. Once fully validated, the UDPB may be useful as an institutional quality measure and serve as an important end point in future cardiac surgical research.
BACKGROUND
The efficacy of surgical stabilization of rib fracture (SSRF) in patients without flail chest has not been studied specifically. We hypothesized that SSRF improves outcomes among patients with displaced rib fractures in the absence of flail chest.
METHODS
Multicenter, prospective, controlled, clinical trial (12 centers) comparing SSRF within 72 hours to medical management. Inclusion criteria were three or more ipsilateral, severely displaced rib fractures without flail chest. The trial involved both randomized and observational arms at patient discretion. The primary outcome was the numeric pain score (NPS) at 2-week follow-up. Narcotic consumption, spirometry, pulmonary function tests, pleural space complications (tube thoracostomy or surgery for retained hemothorax or empyema >24 hours from admission) and both overall and respiratory disability-related quality of life (RD-QoL) were also compared.
RESULTS
One hundred ten subjects were enrolled. There were no significant differences between subjects who selected randomization (n = 23) versus observation (n = 87); these groups were combined for all analyses. Of the 110 subjects, 51 (46.4%) underwent SSRF. There were no significant baseline differences between the operative and nonoperative groups. At 2-week follow-up, the NPS was significantly lower in the operative, as compared with the nonoperative group (2.9 vs. 4.5, p < 0.01), and RD-QoL was significantly improved (disability score, 21 vs. 25, p = 0.03). Narcotic consumption also trended toward being lower in the operative, as compared with the nonoperative group (0.5 vs. 1.2 narcotic equivalents, p = 0.05). During the index admission, pleural space complications were significantly lower in the operative, as compared with the nonoperative group (0% vs. 10.2%, p = 0.02).
CONCLUSION
In this clinical trial, SSRF performed within 72 hours improved the primary outcome of NPS at 2-week follow-up among patients with three or more displaced fractures in the absence of flail chest. These data support the role of SSRF in patients without flail chest.
LEVEL OF EVIDENCE
Therapeutic, level II.
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