Abstract
BACKGROUND: The study aimed at comparing restrictive and liberal transfusion strategy in reducing mortality in patients with upper gastrointestinal bleeding (UGIB). METHODS: This was a single-center, prospective, open-label, non-inferiority, randomized controlled trial conducted over two years. Patients presenting with UGIB were randomized into restrictive (hemoglobin (Hb) <7 g/dl) or liberal (Hb <8 g/dl) transfusion strategy groups. Transfusion was given till patients achieved target Hb of 9 g/dl in restrictive and 10 g/dl in the liberal arms. Patients with exsanguinating bleeding, transfusion within 90 days, recent history of trauma or surgery were excluded. Primary outcome was mortality rate and the secondary outcomes were morbidity, re-bleeding episodes and the need for intervention. RESULTS: A total of 224 patients were randomized to 112 patients in each group. Demographic characteristics were comparable. 45-day mortality was similar between the two groups (restrictive vs. liberal; 10/112 vs. 12/112; P = 0.65). The number of in-hospital bleeding episodes (12 vs. 9; P = 0.25), incidence of re-bleeding during the 45-day follow-up (13 vs. 14; P = 0.84), need for endoscopic banding for varices (37/112 vs. 39/112, P = 0.99), mean hospital stay (days) (3.21 ± 2.78 vs. 2.73 ± 1.29; P = 0.10) were similar between the two groups. CONCLUSION: Restrictive transfusion strategy is non-inferior to liberal transfusion strategy in patients with UGIB.