Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial (original) (raw)
Related papers
Alimentary Pharmacology & Therapeutics, 2010
Aliment Pharmacol Ther 2010; 32: 215–224Aliment Pharmacol Ther 2010; 32: 215–224SummaryBackground Acute upper gastrointestinal bleeding (AUGIB) accounts for 14% of RBC units transfused in the UK. In exsanguinating AUGIB the value of RBC transfusion is self evident, but in less severe bleeding its value is less obvious.Aim To examine the relationship between early RBC transfusion, re-bleeding and mortality following AUGIB, which is one of the most common indications for red blood cell (RBC) transfusion.Method Data were collected on 4441 AUGIB patients presenting to UK hospitals. The relationship between early RBC transfusion, re-bleeding and death was examined using logistic regression.Results 44% were transfused RBCs within 12 hours of admission. In patients transfused with an initial haemoglobin of <8 g/dl, re-bleeding occurred in 23% and mortality was 13% compared with a re-bleeding rate of 15%, and mortality of 13% in those not transfused. In patients transfused with haemoglobin >8 g/dl, re-bleeding occurred in 24% and mortality was 11% compared with a re-bleeding rate of 6.7%, and mortality of 4.3% in those not transfused. After adjusting for Rockall score and initial haemoglobin, early transfusion was associated with a two-fold increased risk of re-bleeding (Odds ratio 2.26, 95% CI 1.76–2.90) and a 28% increase in mortality (Odds ratio 1.28, 95% CI 0.94–1.74).Conclusions Early RBC transfusion in AUGIB was associated with a two-fold increased risk of re-bleeding and an increase in mortality, although the latter was not statistically significant. Although these findings could be due to residual confounding, they indicate that a randomized comparison of restrictive and liberal transfusion policies in AUGIB is urgently required.Background Acute upper gastrointestinal bleeding (AUGIB) accounts for 14% of RBC units transfused in the UK. In exsanguinating AUGIB the value of RBC transfusion is self evident, but in less severe bleeding its value is less obvious.Aim To examine the relationship between early RBC transfusion, re-bleeding and mortality following AUGIB, which is one of the most common indications for red blood cell (RBC) transfusion.Method Data were collected on 4441 AUGIB patients presenting to UK hospitals. The relationship between early RBC transfusion, re-bleeding and death was examined using logistic regression.Results 44% were transfused RBCs within 12 hours of admission. In patients transfused with an initial haemoglobin of <8 g/dl, re-bleeding occurred in 23% and mortality was 13% compared with a re-bleeding rate of 15%, and mortality of 13% in those not transfused. In patients transfused with haemoglobin >8 g/dl, re-bleeding occurred in 24% and mortality was 11% compared with a re-bleeding rate of 6.7%, and mortality of 4.3% in those not transfused. After adjusting for Rockall score and initial haemoglobin, early transfusion was associated with a two-fold increased risk of re-bleeding (Odds ratio 2.26, 95% CI 1.76–2.90) and a 28% increase in mortality (Odds ratio 1.28, 95% CI 0.94–1.74).Conclusions Early RBC transfusion in AUGIB was associated with a two-fold increased risk of re-bleeding and an increase in mortality, although the latter was not statistically significant. Although these findings could be due to residual confounding, they indicate that a randomized comparison of restrictive and liberal transfusion policies in AUGIB is urgently required.
Blood transfusion for upper gastrointestinal bleeding: is less more again?
Critical Care, 2013
Background: The hemoglobin threshold for transfusion of red blood cells in patients with acute gastrointestinal (GI) bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. Methods: Objective: The objective was to prove that the restrictive threshold for red blood cell transfusion in patients with acute upper GI bleeding (UGIB) was safer and more effective than a liberal transfusion strategy. Design: A single-center, randomized controlled trial was conducted. Setting: Patients with GI bleeding were admitted to the de la Santa Creu i Sant Pau hospital in Barcelona, Spain. Subjects: The subjects were adult intensive care unit patients admitted with high clinical suspicion of UGIB (hematomemesis, melena, or both). Patients were excluded if they had massive exsanguinating bleeding, acute coronary syndrome, symptomatic peripheral vascular disease, stroke/transient ischemic attack, transfusion within the previous 90 days, recent trauma or surgery, lower GI bleeding, or a clinical Rockall score of 0 with hemoglobin higher than 12 g/dL. Intervention: A total of 921 patients with severe acute UGIB were enrolled. Of these, 461 were randomly assigned to a restrictive strategy (transfusion when the hemoglobin level fell to below 7 g/dL) and 460 to a liberal strategy (transfusion when the hemoglobin fell to below 9 g/dL). Random assignment was stratified according to the presence or absence of liver cirrhosis. Outcomes: The primary outcome was rate of death from any cause within the first 45 days. Secondary outcomes were further bleeding, defined as hematemesis or melena with hemodynamic instability or hemoglobin decrease of 2 g/dL or more, and in-hospital complications. Results: In total, 225 patients assigned to the restrictive strategy (51%) and 65 assigned to the liberal strategy (15%) 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% versus 91%; hazard ratio (HR) 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 and in 16% of the patients in the liberal-strategy group (P = 0.01), and adverse events occurred in 40% and 48%, respectively (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 (HR 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 (HR 0.30, 95% CI 0.11 to 0.85) but not in those with cirrhosis and Child-Pugh class C disease (HR 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: Compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute UGIB.
Transfusion, 2015
Blood products are commonly transfused for patients with nonvariceal upper gastrointestinal bleeding (NVUGIB). While concerns exist about further bleeding and mortality in subsets of patients receiving red blood cell (RBC) transfusion, the impact of non-RBC blood products has not previously been systematically investigated. The aim of the study was to investigate the associations between blood products transfusion, further bleeding, and mortality after acute NVUGIB. A retrospective cohort study examined further bleeding and 30-day and 1-year mortality in adult patients who underwent gastroscopy for suspected acute NVUGIB between 2008 and 2010 in three tertiary hospitals in Western Australia. Survival analysis was performed. A total of 2228 adults (63% male) with 2360 hospital admissions for NVUGIB met the inclusion criteria. Median age at presentation was 70 years (range, 19-99 years). Thirty-day mortality was 4.9% and 1-year mortality was 13.9%. Transfusion of 4 or more units of RB...
BMJ open, 2013
To carry out a systematic review of recently published large-scale observational studies assessing the effects of red blood cell transfusion (RBCT) on mortality, with particular emphasis on the statistical methods used to adjust for confounding. Given the limited number of randomised trials of the efficacy of RBCT, clinicians often use evidence from observational studies. However, confounding factors, for example, individuals receiving blood generally being sicker than those who do not, make their interpretation challenging. Systematic review. We searched MEDLINE and EMBASE for studies published from 1 January 2006 to 31 December 2010. We included prospective cohort, case-control studies or retrospective analyses of databases or disease registers where the effect of risk factors for mortality or survival was examined. Studies must have included more than 1000 participants receiving RBCT for any cause. We assessed the effects of RBCT versus no RBCT and different volumes and age of RB...
Restrictive versus liberal blood transfusion policy for hepatectomies in cirrhotic patients
World Journal of Surgery, 1989
Background Acute upper gastrointestinal bleeding is a leading indication for red blood cell (RBC) transfusion worldwide, although optimal thresholds for transfusion are debated. Methods We searched MEDLINE, Embase, CENTRAL, CINAHL, and the Transfusion Evidence Library from inception to Oct 20, 2016, for randomised controlled trials comparing restrictive and liberal RBC transfusion strategies for acute upper gastrointestinal bleeding. Main outcomes were mortality, rebleeding, ischaemic events, and mean RBC transfusion. We computed pooled estimates for each outcome by random effects meta-analysis, and individual participant data for a cluster randomised trial were re-analysed to facilitate meta-analysis. We compared treatment effects between patient subgroups, including patients with liver cirrhosis, patients with non-variceal upper gastrointestinal bleeding, and patients with ischaemic heart disease at baseline. Findings We included four published and one unpublished randomised controlled trial, totalling 1965 participants. The number of RBC units transfused was lower in the restrictive transfusion group than in the liberal transfusion group (mean difference-1•73 units, 95% CI-2•36 to-1•11, p<0•0001). Restrictive transfusion was associated with lower risk of all-cause mortality (relative risk [RR] 0•65, 95% CI 0•44-0•97, p=0•03) and rebleeding overall (0•58, 0•40-0•84, p=0•004). We detected no difference in risk of ischaemic events. There were no statistically significant differences in the subgroups. Interpretation These results support more widespread implementation of restrictive transfusion policies for adults with acute upper gastrointestinal bleeding.
Transfusion, 2009
BACKGROUND: Red blood cell (RBC) use varies greatly between countries but the underlying reasons are not well understood. Some insight might be gained from blood utilization studies that provide a complete view of the clinical conditions that place individuals at risk of transfusion. This review considers the methodology of published studies that might provide such information and proposes requirements for future studies. STUDY DESIGN AND METHODS: A literature search was performed to identify quantitative studies of RBC use related to clinical data, for which the findings are representative of well-defined populations. Extraction and analysis of methodologic information and epidemiologic data were performed.