N Engl J Med ; Comments open through March 18, Whether a restrictive threshold for hemoglobin level in red-cell transfusions, as compared with a liberal threshold, reduces postoperative morbidity and health care costs after cardiac surgery is uncertain. Full Text of Background We conducted a multicenter, parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom.

The primary outcome was a serious infection sepsis or wound infection or an ischemic event permanent stroke [confirmation on brain imaging and deficit in motor, sensory, or coordination functions], myocardial infarction, infarction of the gut, or acute kidney injury within 3 months after randomization. Health care costs, excluding the index surgery, were estimated from the day of surgery to 3 months after surgery. Full Text of Methods A total of patients underwent randomization; 4 participants withdrew, leaving in the restrictive-threshold group and in the liberal-threshold group.

Transfusion rates after randomization were The primary outcome occurred in There were more deaths in the restrictive-threshold group than in the liberal-threshold group 4. Serious postoperative complications, excluding primary-outcome events, occurred in Total costs did not differ significantly between the groups.

Full Text of Results A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs. Funded by the National Institute for Health Research Health Technology Assessment program; Current Controlled Trials number, ISRCTN Full Text of Discussion Perioperative anemia is common after cardiac surgery and is associated with significant increases in morbidity and mortality.

Observational studies suggest that transfusion is harmful after cardiac surgery; associations have been reported between transfusion and infection, low cardiac output, acute kidney injury, and death. TITRe2 was a multicenter, parallel-group, randomized, controlled trial conducted at 17 cardiac surgery centers in the United Kingdom.

Details of the methods have been reported previously. A National Health Service research ethics committee approved the study, which was conducted in accordance with the principles of the International Conference on Harmonisation-Good Clinical Practice under the oversight of University Hospitals Bristol National Health Service Foundation Trust.

The last author vouches for the data and the analyses and for the fidelity of this report to the study protocol available with the full text of this article at NEJM. Patients older than 16 years of age who were undergoing nonemergency cardiac surgery were eligible to participate; exclusion criteria 23 are described in Table S1 in the Supplementary Appendixavailable at NEJM.

Participants provided written informed consent before surgery. Thresholds were expressed in terms of hemoglobin level or hematocrit; hereinafter, hemoglobin threshold should be interpreted as a reference to either hemoglobin level or hematocrit.

Patients were randomly assigned to either the liberal transfusion-threshold group threshold hemoglobin level, 9 g per deciliter or the restrictive transfusion-threshold group threshold hemoglobin level, 7.

Physicians and nurses were aware of the group assignments.

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We intended participants to be unaware of the group assignments and tested our success in keeping the study groups blinded by asking the patients if they were aware of the group they were in.

Participants in the liberal-threshold group received a transfusion of 1 unit of red cells immediately after randomization. In the restrictive-threshold group, 1 unit of red cells was transfused if the hemoglobin level dropped below 7.

Physicians could contravene the assigned threshold but had to document the reason for the contravention and record the hemoglobin level at the time of the contravention. Similarly, a physician could permanently discontinue adherence to the assigned treatment threshold. This discontinuation did not constitute withdrawal of the participant from the study, and we continued to collect outcome data in accordance with the protocol for all such participants and included them in the analysis population.

The primary outcome was a composite of a serious infection sepsis or wound infection or an ischemic event permanent stroke, myocardial infarction, infarction of the gut, or acute kidney injury 27 within 3 months after randomization.

Definitions and adjudication procedures are described in Table S2 in the Supplementary Appendix. Several secondary outcomes were prespecified, including the number of units of red cells and other blood components transfused after randomization; the occurrence of an infection either sepsis or wound infection, as for the primary outcome, but not including ischemic events ; the occurrence of an ischemic event permanent stroke, myocardial infarction, infarction of the gut, or acute kidney injury, as for the primary outcome, but not including infections ; the duration of stay in the intensive care unit ICUa high-dependency unit in which care is less intensive than in an ICU but more intensive than in a hospital wardor the hospital; and all-cause mortality.

The presence of a clinically significant pulmonary complication defined according to the need for noninvasive ventilation, reintubation, or ventilation or a tracheostomy was added as a secondary outcome in an amendment to the protocol dated December 2, All serious adverse events that occurred during follow-up were documented and coded in accordance with the Medical Dictionary for Regulatory Activitiesversion General health status was assessed at 6 weeks and 3 months after surgery with the use of the EuroQol Group 5-Dimension Self-Report Questionnaire EQ-5D.

For both the index score and the score on a visual-analogue scale, higher scores indicate better quality of life. Multiple instances of nonadherence could occur for one patient. An instance of nonadherence was considered to be severe when it changed the classification of a patient with respect to receipt of any transfusion i. We performed a cost analysis in accordance with guidelines established in the United Kingdom by the National Institute for Health and Care Excellence.

Resources included blood products and any resources associated with complications including diagnostic testslength of hospital stay, and various levels of care up to 3 months after surgery; the costs of the index surgery were not included.

Further details of the cost analysis are provided in the Supplementary Appendix. The target sample size was increased to to account for uncertainty regarding the rate of nonadherence, since higher-than-expected rates of nonadherence would reduce the power. All the analyses were performed on an intention-to-treat basis according to a prespecified analysis plan.

All the analyses were based on mixed-effects methods, with adjustment for the type of surgery as a fixed effect and center as a random effect described as shared-frailty terms in time-to-event models. Binary outcomes were analyzed with the use of logistic regression. EQ-5D scores were analyzed with the use of mixed-effects, mixed-distribution models. We compared the frequency of the primary outcome in prespecified subgroups by estimating the interaction between group assignment and subgroup variable.

Sensitivity analyses were performed for the primary outcome as described in the Supplementary Appendix and for mortality. Likelihood-ratio tests were performed. No formal adjustment was made for multiple testing or for an interim analysis. Patients were screened for eligibility between July and February ; a total of consented to take part in the study Fig.

S1 in the Supplementary Appendixof whom underwent randomization between July 15,and February 18, Four participants withdrew and requested that their data be excluded from the study. Therefore, the analysis population consisted of participants — in the restrictive-threshold group and in the liberal-threshold group.

The baseline characteristics were similar in the two groups Table 1 Table 1 Preoperative and Intraoperative Characteristics. The median age was Most patients had undergone coronary-artery bypass grafting A total of The baseline characteristics of patients who consented to participate but did not undergo randomization are shown in Table S4 in the Supplementary Appendix.

At 3 months after surgery, a greater number of patients After randomization, the mean nadir in the hemoglobin level was approximately 1 g per deciliter lower in the group assigned to the restrictive threshold than in the group assigned to the liberal threshold Figure 1 Figure 1 Mean Daily Nadir in Hemoglobin Level.

I bars indicate standard deviations, which were calculated independently at each time point. S2A in the Supplementary Appendix. A median of 1 unit of red cells interquartile range, 0 to 2 was transfused in the restrictive-threshold group, and a median of 2 units interquartile range, 1 to 3 were transfused in the liberal-threshold group. During the entire index admission, The use of other blood products was similar in the two groups Table 2and Table S5 and Fig.

S2B in the Supplementary Appendix. The rate of severe nonadherence was 9. Outcome data at 3 months after randomization were not obtained for 25 participants 1. S1 in the Supplementary Appendix. The numbers of patients with data for each outcome analysis are shown in Table S6 in the Supplementary Appendix ; for the primary outcome analysis overall, data were missing for 97 of participants 4. The primary outcome was observed in S3 in the Supplementary Appendix.

The majority of primary outcome events in each group occurred before hospital discharge Table S7 in the Supplementary Appendix. The Supplementary Appendix includes additional details regarding the primary outcome, including the reasons for missing data Table S6the distribution of primary-outcome events before and after hospital discharge Table S7and a Kaplan—Meier plot of the time from randomization to the primary outcome Fig.

The duration of patient stay in the ICU or high-dependency unit did not differ significantly between the two groups, and the rates of clinically significant pulmonary complications were also similar Table 3. There were significantly more deaths in the restrictive-threshold group than in the liberal-threshold group 4. Table S8 in the Supplementary Appendix shows the causes of death. Mortality at 30 days was 2. Kaplan—Meier curves are shown in Figure S4 in the Supplementary Appendix.

EQ-5D scores were similar in the two groups Table S9 in the Supplementary Appendix. The rate of serious postoperative complications excluding primary-outcome events was When additional acute kidney injury events, identified by means of routinely collected data on creatinine level, were included in the primary outcome, there was a trend toward higher risk in the restrictive-threshold group than in the liberal-threshold group odds ratio, 1. A similar trend was seen when patients who received a transfusion before randomization were excluded from the primary-outcome analysis odds ratio, 1.

When the primary outcome was restricted to serious events, there was no significant difference between the two groups odds ratio, 0. S5 in the Supplementary Appendix.

There was no indication of significant heterogeneity with respect to the primary outcome according to subgroup Figure 2 Figure 2 Subgroup Analyses. The sizes of the circles designating the point estimates reflect the sizes of the subgroups. The restrictive transfusion threshold for hemoglobin was less than 7. CABG denotes coronary-artery bypass grafting, COPD chronic obstructive pulmonary disease, GFR glomerular filtration rate, and LV left ventricular.

In the TITRe2 trial, we tested the hypothesis that the use of a restrictive threshold, as compared with a liberal threshold, for the transfusion of red cells after cardiac surgery in adults would reduce postoperative morbidity and costs.

We observed no significant between-group difference with respect to the primary composite outcome. This finding cannot be explained by the possibility that the study did not have adequate power, since the power of the study was greater than that planned because of the higher-than-expected frequency of the outcome.

More patients in the restrictive-threshold group than in the liberal-threshold group died 4. There were no significant differences in other secondary outcomes, including total costs, between the two strategies. Our results differ from those of observational analyses of transfusion in patients undergoing cardiac surgery, 36 which have uniformly showed that red-cell transfusion is associated with an increased risk of death and other serious adverse outcomes.

The difference is probably due to the fact that observational analyses are confounded by prognostic factors that influence the decision to transfuse red cells. In contrast, our results are consistent with findings of a Cochrane review of randomized, controlled trials involving surgical patients and critically ill patients, 9 in which the clinical outcomes in patients who received transfusions with restrictive thresholds for hemoglobin level were similar to those in patients who received transfusion with liberal thresholds.

A restrictive threshold for transfusion is likely to be favored because it requires the use of fewer units of allogeneic red cells. However, the results of our secondary analyses create new uncertainty regarding the use of a restrictive threshold for transfusion after cardiac surgery.

It is challenging to interpret the results of secondary analyses when several statistical tests are performed, 37 but the higher frequency of death in the restrictive-threshold group, which persisted in sensitivity analyses Table S11 in the Supplementary Appendixis a cause for concern.

It is not clear in what way anemia that was attributable to the restrictive threshold may have resulted in an increased number of deaths. The difference in hemoglobin level between the groups was modest 1 g per deciliterand an assessment of causes of death or of severe adverse events that preceded death did not suggest a cause-and-effect relationship, although establishing a cause-and-effect relationship may have been an unrealistic expectation given the small number of deaths that occurred and given a medical setting cardiac surgery in which death typically occurs after a sequence of adverse events.

A benefit from transfusion with a more liberal hemoglobin threshold was also suggested in two sensitivity analyses of the primary outcome, one in which patients who had received a transfusion before randomization were excluded and one in which additional acute kidney injury events, as determined on the basis of serial data on creatinine levels, were included.

These findings seem to support a hypothesis that the use of a more liberal hemoglobin threshold may be beneficial in patients with a hemoglobin level of less than 9 g per deciliter after cardiac surgery.

This hypothesis is clinically plausible. The TITRe2 trial differs from previous large trials of transfusion thresholds in that all the participants had cardiovascular disease 38,39 ; stock brokers in edmonton addition, a substantial proportion of participants are likely to have been dependent on oxygen supplementation in the immediate postoperative period.

Such patients were excluded from the only contemporary trial we could find that showed restrictive transfusion to be beneficial, a trial that assessed transfusion thresholds in patients with acute upper gastrointestinal bleeding. This hypothesis should be tested in future pragmatic trials. The main limitation of our trial was our inability to keep health care staff unaware of the group assignments. How to start trading stocks singapore, the use of objective end points and the adjudication of end points by personnel who were unaware of the group assignments protected against detection bias.

The nature of nonadherence to protocol differed according to group but affected the overall transfusion rate in only a small percentage of participants. This percentage was similar in the two groups. Another live trading room binary options was that prospective data collection failed to identify acute kidney injury events that were apparent on the basis of the routinely collected data on serial creatinine levels.

We attribute this binary options profitable trading system striker9 download to differences among centers in the baseline creatinine value used to define acute kidney injury.

In conclusion, the TITRe2 trial compared a restrictive transfusion threshold with a liberal transfusion threshold after cardiac surgery. The restrictive threshold was not superior to the liberal threshold with respect to postoperative morbidity or total costs. Supported by the NIHR Health Technology Assessment program ref: Reeves and the research nurse team in Bristol were supported in part by the NIHR Bristol Biomedical Research Unit in Binary option strategies of containment Disease, and Drs.

Murphy, Angelini, and Rogers were supported by the British Heart Foundation ref: Disclosure forms provided by the authors are available with the full text of this article at NEJM. The views and opinions expressed are those of the authors and do not necessarily reflect those of the National Institute for Health Research NIHR Health Technology Assessment program, the British Heart Foundation, the National Health Service, or the Department of Health.

From the British Heart Foundation, Department of Cardiovascular Sciences, University of Leicester, and Glenfield General Hospital, Leicester G. Address reprint requests to Dr.

Reeves at the Bristol Heart Institute, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom, or at barney. A complete list of investigators in the Transfusion Indication Threshold Reduction TITRe2 study is provided in the Supplementary Appendixavailable at NEJM.

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A Multicenter Randomized Controlled Trial. JMIR Research Protocols 4: See related Challenge and other articles in the series. Liberal or Restrictive Transfusion after Cardiac Surgery. The New England Journal of Medicine. The narration and closed captions in this video are in English.

Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. A Correction Has Been Published. Background Whether a restrictive threshold for hemoglobin level in red-cell transfusions, as compared with a liberal threshold, reduces postoperative morbidity and health care costs after cardiac surgery is uncertain. Methods We conducted a multicenter, parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom.

Results A total of patients underwent randomization; 4 participants withdrew, leaving in the restrictive-threshold group and in the liberal-threshold group. Conclusions A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs.

Media in This Article Figure 1 Mean Daily Nadir in Hemoglobin Level. Figure 2 Subgroup Analyses. Article Activity articles have cited this article. Methods Trial Design and Oversight TITRe2 was a multicenter, parallel-group, randomized, controlled trial conducted at 17 cardiac surgery centers in the United Kingdom. Participants Patients older than 16 years of age who were undergoing nonemergency cardiac surgery were eligible to participate; exclusion criteria 23 are described in Table S1 in the Supplementary Appendixavailable at NEJM.

Randomization Patients were randomly assigned to either the liberal transfusion-threshold group threshold hemoglobin level, 9 g per deciliter or the restrictive transfusion-threshold group threshold hemoglobin level, 7. Interventions Participants in the liberal-threshold group received a transfusion of 1 unit of red cells immediately after randomization. Outcomes The primary outcome was a composite of a serious infection sepsis or wound infection or an ischemic event permanent stroke, myocardial infarction, infarction of the gut, or acute kidney injury 27 within 3 months after randomization.

Cost Analysis We performed a cost analysis in accordance with guidelines established in the United Kingdom by the National Institute for Health and Care Excellence. Results Study Population Patients were screened for eligibility between July and February ; a total of consented to take part in the study Fig.

Hemoglobin Levels and Transfusions After randomization, the mean nadir in the hemoglobin level was approximately 1 g per deciliter lower in the group assigned to the restrictive threshold than in the group assigned to the liberal threshold Figure 1 Figure 1 Mean Daily Nadir in Hemoglobin Level.

Outcomes Outcome data at 3 months after randomization were not obtained for 25 participants 1. Sensitivity and Subgroup Analyses When additional acute kidney injury events, identified by means of routinely collected data on creatinine level, were included in the primary outcome, there was a trend toward higher risk in the restrictive-threshold group than in the liberal-threshold group odds ratio, 1. Discussion In the TITRe2 trial, we tested the hypothesis that the use of a restrictive threshold, as compared with a liberal threshold, for the transfusion of red cells after cardiac surgery in adults would reduce postoperative morbidity and costs.

No potential conflict of interest relevant to this article was reported. This article was last updated on May 22,at NEJM. Source Information From the British Heart Foundation, Department of Cardiovascular Sciences, University of Leicester, and Glenfield General Hospital, Leicester G. References 1 Habib RHZacharias ASchwann TAet al.

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