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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV): a randomized clinical feasibility trial

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Current guidelines advocate to limit red-cell transfusion during surgery, but the feasibility and safety of such strategy remains unclear as the majority of evidence is based on postoperative stable patients. We assessed the effects of a protocol aiming to restrict red-cell transfusion throughout hospitalization for vascular surgery. Fifty-eight patients scheduled for lower limb-bypass or open abdominal aortic aneurysm repair were randomized upon hemoglobin drop below 9.7g/dL to a low-trigger (hemoglobin<8.0 g/dL) vs. high-trigger (hemoglobin<9.7 g/dL) for red-cell transfusion. Intraoperative oxygen desaturation in cerebral- and muscle tissue was assessed by near-infrared spectroscopy. An explorative outcome included data on death and major vascular complications from a nationwide registry. The primary outcome, mean hemoglobin within 15 days of surgery, was significantly lower in the low-trigger group: 9.46 g/dL vs. 10.33 g/dL in the high-trigger group (mean difference, 0.87g/dL; P=0.022; longitudinal analysis) as were units of red-cells transfused (median [interquartile range(IQR)], 1 [0-2] vs. 3 [2-6]; P=0.0015). While the duration and magnitude of cerebral oxygen desaturation from baseline increased in the low-trigger group (median [IQR], 421 minutes*% [42-888] vs. 127 [11-331]; P=0.0036), muscle oxygenation was unaffected. The low-trigger associated to a higher rate of death or major vascular complications: 19/29 vs. 8/29 (hazard ratio, 3.20; P=0.006) and fewer days alive outside hospital within 90 days (median [IQR], 76 [67-82] vs. 82 [76-84] days; P=0.049). In conclusion, a perioperative protocol restricting red-cell transfusion successfully separated hemoglobin levels and red-cell units transfused. Exploratory outcomes suggested potential harm with the low-trigger and warrants further trials in vascular surgery before such strategy is universally adopted. (ClinicalTrials.gov identifier NCT02465125).

Original languageEnglish
JournalBlood
Volume133
Issue number25
Pages (from-to)2639-2650
ISSN0006-4971
DOIs
Publication statusPublished - 11 Mar 2019

ID: 56914766