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Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.
In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.
Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.
These results suggest a need for a large, randomized trial, according to investigators.
“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.
He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.
The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.
The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.
Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.
Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.
The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.
In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.
All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.
At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.
At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.
At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.
By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.
Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB. 
Photo by Elise Amendola
Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.
In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.
Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.
These results suggest a need for a large, randomized trial, according to investigators.
“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.
He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.
The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.
The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.
Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.
Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.
The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.
In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.
All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.
At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.
At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.
At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.
By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.
Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB.
Photo by Elise Amendola
Results of a pilot study suggest a restrictive transfusion strategy may be safe for patients with acute upper gastrointestinal bleeding (AUGIB), but investigators say more research is needed.
In this study, known as TRIGGER, use of a restrictive transfusion strategy led to a 13% reduction in red blood cell (RBC) transfusions compared to the liberal strategy, but this difference was not statistically significant.
Likewise, there was no significant difference in clinical outcomes whether AUGIB patients received transfusions according to the restrictive strategy or the liberal one.
These results suggest a need for a large, randomized trial, according to investigators.
“If restrictive practice is proven to be safe in a large study, it could potentially safely reduce the use of red blood cell transfusions and produce cost savings . . . ,” said Vipul Jairath, MBChB, DPhil, of Oxford University Hospitals in the UK.
He and his colleagues conducted the TRIGGER trial and reported the results in The Lancet.
The study included 6 hospitals that had more than 20 AUGIB admissions monthly, more than 400 adult beds, 24-hour endoscopy, and onsite intensive care and surgery. Patients were eligible if they presented with new AUGIB (defined by hematemesis or melena) and were 18 or older. The only exclusion criterion was exsanguinating hemorrhage.
The investigators enrolled 936 patients—403 on the restrictive transfusion arm and 533 on the liberal arm. Patients in the restrictive arm were eligible to receive RBCs when their hemoglobin concentration fell below 80 g/L, with a post-transfusion target of 81-100 g/L.
Patients in the liberal arm were eligible for transfusion when their hemoglobin concentration fell below 100 g/L, with a post-transfusion target of 101-120 g/L. These thresholds were informed by UK transfusion practices.
Protocol adherence was 96% in the restrictive arm and 83% in the liberal arm. The mean last recorded hemoglobin concentration was 116 g/L for the restrictive arm and 118 g/L for the liberal arm.
The investigators noted that there was a 13% absolute reduction in the proportion of patients transfused in the restrictive arm, a reduction in the amount of RBCs transfused between the arms, and a separation in hemoglobin concentration between the arms, but none of these differences were significant.
In addition, there was no significant difference in clinical outcomes between the arms, although the trial was not powered to assess these outcomes.
All-cause mortality at day 28 was 7% in the liberal transfusion arm and 5% in the restrictive arm. The rate of serious adverse events at day 28 was 22% and 18%, respectively.
At hospital discharge, further bleeding had occurred in 6% of patients in the liberal arm and 4% in the restrictive arm. At day 28, further bleeding had occurred in 9% and 5%, respectively.
At discharge, thromboembolic or ischemic events had occurred in 5% of patients in the liberal arm and 3% in the restrictive arm. At day 28, these events had occurred in 7% and 4%, respectively.
At discharge, acute transfusion reactions had occurred in 2% of patients in the liberal arm and 1% in the restrictive arm, and infections had occurred in 24% and 26%, respectively.
By discharge, 38% of patients in the liberal arm and 32% in the restrictive arm had required some therapeutic intervention. Surgical or radiological intervention was required in 3% and 4%, respectively.
Considering these results, the investigators said the TRIGGER trial has paved the way for a phase 3 trial that could provide evidence to inform transfusion guidelines for patients with AUGIB.