A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (P<0.001). The probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [CI], 0.33 to 0.92; P = 0.02). Further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (P = 0.01), and adverse events occurred in 40% as compared with 48% (P = 0.02). The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% CI, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and Child–Pugh class A or B disease (hazard ratio, 0.30; 95% CI, 0.11 to 0.85), but not in those with cirrhosis and Child–Pugh class C disease (hazard ratio, 1.04; 95% CI, 0.45 to 2.37). Within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (P = 0.03) but not in those assigned to the restrictive strategy. Conclusions As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (Funded by Fundacio Investigacio Sant Pau; ClinicalTrials.gov number, NCT00414713.)

/pdf/transfusion-strategies-for-acute-upper-gastrointestinal-4cve0qnwwf.pdf

Transfusion strategies for acute upper gastrointestinal bleeding.

Objective To describe the patient characteristics, diagnoses and clinical outcomes of patients presenting with acute upper gastrointestinal bleeding (AUGIB) in the 2007 UK Audit. Design Multi-centre survey. Setting All UK hospitals admitting patients with AUGIB. Participants All adults (>16 years) presenting in or to UK hospitals with AUGIB between 1 May and 30 June 2007. Results Data on 6750 patients (median age 68 years) was collected from 208 participating hospitals. New admissions (n=5550) were younger (median age 65 years) than inpatients (n=1107, median age 71 years), with less co-morbidity (any co-morbidity 46% vs 71%, respectively). At presentation 9% (599/6750) had known cirrhosis, 26% a history of alcohol excess, 11% were taking non-steroidal anti-inflammatory drugs and 28% aspirin. Peptic ulcer disease accounted for 36% of AUGIB and bleeding varices 11%. In 13% there was evidence of further bleeding after the first endoscopy. 1.9% underwent surgery and 1.2% interventional radiology for AUGIB. Median length of stay was 5 days. Overall mortality in hospital was 10% (675/6750, 95% CI 9.3 to 10.7), 7% in new admissions and 26% among inpatients. Mortality was highest in those with variceal bleeding (15%) and with malignancy (17%). Conclusions AUGIB continues to result in substantial mortality although it appears to be lower than in 1993. Mortality is particularly high among inpatients and those bleeding from varices or upper gastrointestinal malignancy. Surgical or radiological interventions are little used currently.

https://gut.bmj.com/content/gutjnl/60/10/1327.full.pdf

Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit

In patients with significant gastrointestinal haemorrhage, the use of a transfusion trigger of a haemoglobin level of 7 g/dL instead of 9 g/dL demonstrated a significant survival benefit (NNT 25) together with a significant reduction in rates of rebleeding, adverse events and use of blood products.Level of evidence: 2B (non-blind, single centre RCT with a risk of bias)

http://inc.sagepub.com/content/14/4/357.full.pdf

Transfusion Strategies for Acute Upper Gastrointestinal Bleeding

https://www.westicu.cn/UpFile/201506/2015061972819561.pdf

Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial

Cluster randomised trials (CRTs) are commonly analysed using mixed-effects models or generalised estimating equations (GEEs). However, these analyses do not always perform well with the small number of clusters typical of most CRTs. They can lead to increased risk of a type I error (finding a statistically significant treatment effect when it does not exist) if appropriate corrections are not used. We conducted a small simulation study to evaluate the impact of using small-sample corrections for mixed-effects models or GEEs in CRTs with a small number of clusters. We then reanalysed data from TRIGGER, a CRT with six clusters, to determine the effect of using an inappropriate analysis method in practice. Finally, we reviewed 100 CRTs previously identified by a search on PubMed in order to assess whether trials were using appropriate methods of analysis. Trials were classified as at risk of an increased type I error rate if they did not report using an analysis method which accounted for clustering, or if they had fewer than 40 clusters and performed an individual-level analysis without reporting the use of an appropriate small-sample correction. Our simulation study found that using mixed-effects models or GEEs without an appropriate correction led to inflated type I error rates, even for as many as 70 clusters. Conversely, using small-sample corrections provided correct type I error rates across all scenarios. Reanalysis of the TRIGGER trial found that inappropriate methods of analysis gave much smaller P values (P ≤ 0.01) than appropriate methods (P = 0.04–0.15). In our review, of the 99 trials that reported the number of clusters, 64 (65 %) were at risk of an increased type I error rate; 14 trials did not report using an analysis method which accounted for clustering, and 50 trials with fewer than 40 clusters performed an individual-level analysis without reporting the use of an appropriate correction. CRTs with a small or medium number of clusters are at risk of an inflated type I error rate unless appropriate analysis methods are used. Investigators should consider using small-sample corrections with mixed-effects models or GEEs to ensure valid results.

/pdf/increased-risk-of-type-i-errors-in-cluster-randomised-trials-3uqxcfxhw8.pdf

Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study.

Aliment Pharmacol Ther 2010; 32: 215–224

Outcomes following early red blood cell transfusion in acute upper gastrointestinal bleeding

Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

Early coagulopathy is associated with increased mortality and re-bleeding in non-cirrhotics with acute upper gastrointestinal bleeding

We thank Chakrabaty and colleagues for their letter.1 As they mention, the full Rockall score was designed (and has been validated) for use in identifying patients at risk of death from acute upper gastrointestinal bleeding (AUGIB),2 ,3 and we believe this is the best use of the score. It has also recently been shown to be comparable with the Glasgow Blatchford Score …

https://gut.bmj.com/content/gutjnl/early/2012/03/01/gutjnl-2012-302162.full.pdf

Acute upper gastrointestinal bleeding: identifying low risk patients

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Papers

Outcomes following early red blood cell transfusion in acute upper gastrointestinal bleeding

Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

Early coagulopathy is associated with increased mortality and re-bleeding in non-cirrhotics with acute upper gastrointestinal bleeding

Acute upper gastrointestinal bleeding: identifying low risk patients