Low vs high hemoglobin trigger for transfusion in vascular surgery: a randomized clinical feasibility trial

• Published in: Blood Vol. 133; no. 25; pp. 2639 - 2650
• Main Authors: Møller, Anders, Nielsen, Henning B., Wetterslev, Jørn, Pedersen, Ole B., Hellemann, Dorthe, Winkel, Per, Marcussen, Klaus V., Ramsing, Benedicte G.U., Mortensen, Anette, Jakobsen, Janus C., Shahidi, Saeid
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 20.06.2019
• Subjects: Adult; Clinical Protocols; Erythrocyte Transfusion - methods; Feasibility Studies; Female; Hemoglobins - analysis; Humans; Male; Middle Aged; Vascular Surgical Procedures - methods
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2018-10-877530

Current guidelines advocate to limit red blood cell (RBC) transfusion during surgery, but the feasibility and safety of such a strategy remain unclear, as the majority of evidence is based on postoperatively stable patients. We assessed the effects of a protocol aiming to restrict RBC transfusion throughout hospitalization for vascular surgery. Fifty-eight patients scheduled for lower limb bypass or open abdominal aortic aneurysm repair were randomly assigned, on hemoglobin drop below 9.7 g/dL, to either a low-trigger (hemoglobin < 8.0 g/dL) or a high-trigger (hemoglobin < 9.7 g/dL) group for RBC transfusion. Near-infrared spectroscopy assessed intraoperative oxygen desaturation in brain and muscle. Explorative outcomes included nationwide registry data on death and major vascular complications. The primary outcome, mean hemoglobin within 15 days of surgery, was significantly lower in the low-trigger group, at 9.46 vs 10.33 g/dL in the high-trigger group (mean difference, −0.87 g/dL; P = .022), as were units of RBCs transfused (median [interquartile range (IQR)], 1 [0-2] vs 3 [2-6]; P = .0015). Although the duration and magnitude of cerebral oxygen desaturation increased in the low-trigger group (median [IQR], 421 [42-888] vs 127 [11-331] minutes × %; P = .0036), muscle oxygenation was unaffected. The low-trigger group associated to a higher rate of death or major vascular complications (19/29 vs 8/29; hazard ratio, 3.20; P = .006) and fewer days alive outside the hospital within 90 days (median [IQR], 76 [67-82] vs 82 [76-84] days; P = .049). In conclusion, a perioperative protocol restricting RBC transfusion successfully separated hemoglobin levels and RBC units transfused. Exploratory outcomes suggested potential harm with the low-trigger group and warrant further trials before such a strategy is universally adopted. This trial was registered at www.clinicaltrials.gov as #NCT02465125. •Perioperative restriction of red cells significantly lowered hemoglobin levels, red cell units transfused, and cerebral tissue oxygenation.•Explorative outcomes indicated harm with the low transfusion trigger and warrants further trials to establish whether such strategy is safe. [Display omitted]