"Restrictive versus Liberal Transfusion Strategy in Patients with Acute Upper Gastrointestinal Bleeding".The New England Journal of Medicine. 2013. 368:11-21.PubMed•ClinicalTrials.gov number, NCT00414713•PDF

Clinical Question

In patients with acute upper gastrointestinal bleeding, is a restrictive transfusion strategy (transfusion at Hb <7 g/dL) more effective and safer than a liberal transfusion strategy (transfusion at Hb <9 g/dL)?

Bottom Line

Among patients with acute upper gastrointestinal bleeding, a restrictive transfusion strategy (Hb threshold for transfusion, <7 g/dL) improved survival rates and other clinical outcomes compared with a liberal transfusion strategy (Hb threshold for transfusion, <9 g/dL).

Major Points

A restrictive transfusion strategy (transfusing when Hb <7 g/dL) led to higher survival rates at 6 weeks (95% vs. 91%) and decreased rates of repeat bleeding and adverse events compared with a liberal transfusion strategy (transfusing when Hb <9 g/dL) in patients with upper gastrointestinal bleeding.

Guidelines

Following the results of this trial, international guidelines suggest lowering the Hb threshold for transfusion in patients with gastrointestinal bleeding from 10 g/dL to 7 g/dL.

Design

- Multicenter, randomized, controlled trial
- N=921 patients with acute upper gastrointestinal bleeding
- Restrictive strategy (n=461), liberal strategy (n=460)
- Setting: Single center in Barcelona, Spain
- Enrollment: 2003-2009
- Follow up: 45 days
- Analysis: Intention-to-treat
- Primary outcome: All-cause mortality at 45 days

Population

Inclusion Criteria:
- Patients ≥18 years old with hematemesis, melena, or both
- Hospital staff confirmation of bleeding

Exclusion Criteria:
- Refusal of blood transfusion
- Massive exsanguinating bleeding, recent acute coronary syndrome, symptomatic peripheral vasculopathy, stroke, recent trauma or surgery, lower GI bleeding, recent transfusion, clinical Rockall score of 0 with Hb >12 g/dL

Baseline Characteristics
- Similar between groups
- 31% had cirrhosis
- Bleeding source: peptic ulcer (49%), esophageal varices (21%)

Interventions

- Restrictive strategy: Transfuse if Hb <7 g/dL
- Liberal strategy: Transfuse if Hb <9 g/dL
- Followed until discharge or death
- Protocol deviations allowed for clinically significant anemia, massive rebleeding, or need for surgical intervention

Outcomes

Primary Outcomes
- 45-day all-cause mortality: Restrictive group 5% vs. Liberal group 9% (P=0.02)

Secondary Outcomes
- Further bleeding: Restrictive group 10% vs. Liberal group 16% (P=0.01)
- In-hospital complications: Restrictive group 40% vs. Liberal group 48% (P=0.02)

Criticisms

- Not generalizable to all patients with gastrointestinal bleeding, such as those with low-risk or massive exsanguinating hemorrhage
- Potential bias due to non-blinded design

Funding

- Fundació Investigació Sant Pau

Further Reading

Updates to the article and related letters can be found at NEJM.org.