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Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV): a randomized clinical feasibility trial

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Møller, A, Nielsen, HB, Wetterslev, J, Pedersen, OB, Hellemann, D, Winkel, P, Marcussen, KV, Ramsing, BGU, Mortensen, A, Jakobsen, JC & Shahidi, S 2019, 'Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV): a randomized clinical feasibility trial' Blood, bind 133, nr. 25, s. 2639-2650. https://doi.org/10.1182/blood-2018-10-877530

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Author

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. / Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV) : a randomized clinical feasibility trial. I: Blood. 2019 ; Bind 133, Nr. 25. s. 2639-2650.

Bibtex

@article{f70999188d8f43339cc6669fa1ffaf09,
title = "Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV): a randomized clinical feasibility trial",
abstract = "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).",
author = "Anders M{\o}ller and Nielsen, {Henning B} and J{\o}rn Wetterslev and Pedersen, {Ole B} and Dorthe Hellemann and Per Winkel and Marcussen, {Klaus V} and Ramsing, {Benedicte G U} and Anette Mortensen and Jakobsen, {Janus C} and Saeid Shahidi",
note = "Copyright {\circledC} 2019 American Society of Hematology.",
year = "2019",
month = "3",
day = "11",
doi = "10.1182/blood-2018-10-877530",
language = "English",
volume = "133",
pages = "2639--2650",
journal = "Blood",
issn = "0006-4971",
publisher = "American Society of Hematology",
number = "25",

}

RIS

TY - JOUR

T1 - Low vs. high hemoglobin trigger for Transfusion in Vascular surgery (TV)

T2 - a randomized clinical feasibility trial

AU - Møller, Anders

AU - Nielsen, Henning B

AU - Wetterslev, Jørn

AU - Pedersen, Ole B

AU - Hellemann, Dorthe

AU - Winkel, Per

AU - Marcussen, Klaus V

AU - Ramsing, Benedicte G U

AU - Mortensen, Anette

AU - Jakobsen, Janus C

AU - Shahidi, Saeid

N1 - Copyright © 2019 American Society of Hematology.

PY - 2019/3/11

Y1 - 2019/3/11

N2 - 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).

AB - 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).

U2 - 10.1182/blood-2018-10-877530

DO - 10.1182/blood-2018-10-877530

M3 - Journal article

VL - 133

SP - 2639

EP - 2650

JO - Blood

JF - Blood

SN - 0006-4971

IS - 25

ER -

ID: 56914766