Hosseinali Khalili1, Rebecka Ahl2,3, Shahram Paydar4,5, Gabriel Sjolin6,3, Yang Cao7, Hossein Abdolrahimzadeh Fard2,4, Amin Niakan1, Kamil Hanna8, Bellal Joseph8, Shahin Mohseni9,10. 1. Department of Neurosurgery, Trauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. 2. Department of Surgery, Karolinska University Hospital, Stockholm, Sweden. 3. School of Medical Sciences, Orebro University, 702 81, Örebro, Sweden. 4. Trauma Research Center, Rajaee (Emtiaz) Trauma Hospital, Shiraz University of Medical Sciences, Shiraz, Iran. 5. Department of Surgery, Shiraz University of Medical Sciences, Shiraz, Iran. 6. Department of Surgery, Orebro University Hospital, 701 85, Örebro, Sweden. 7. Clinical Epidemiology and Biostatistics, School of Medical Sciences, Orebro University, 701 82, Örebro, Sweden. 8. Department of Surgery, University of Arizona College of Medicine, Tucson, AZ, USA. 9. School of Medical Sciences, Orebro University, 702 81, Örebro, Sweden. mohsenishahin@yahoo.com. 10. Division of Trauma and Emergency Surgery, Department of Surgery, Orebro University Hospital, 701 85, Örebro, Sweden. mohsenishahin@yahoo.com.
Abstract
BACKGROUND: Observational studies have demonstrated improved outcomes in TBI patients receiving in-hospital beta-blockers. The aim of this study is to conduct a randomized controlled trial examining the effect of beta-blockers on outcomes in TBI patients. METHODS:Adult patients with severe TBI (intracranial AIS ≥ 3) were included in the study. Hemodynamically stable patients at 24 h after injury were randomized to receive either 20 mg propranolol orally every 12 h up to 10 days or until discharge (BB+) or no propranolol (BB-). Outcomes of interest were in-hospital mortality and Glasgow Outcome Scale-Extended (GOS-E) score on discharge and at 6-month follow-up. Subgroup analysis including only isolated severe TBI (intracranial AIS ≥ 3 with extracranial AIS ≤ 2) was carried out. Poisson regression models were used. RESULTS:Two hundred nineteen randomized patients of whom 45% received BB were analyzed. There were no significant demographic or clinical differences between BB+ and BB- cohorts. No significant difference in in-hospital mortality (adj. IRR 0.6 [95% CI 0.3-1.4], p = 0.2) or long-term functional outcome was measured between the cohorts (p = 0.3). One hundred fifty-four patients suffered isolated severe TBI of whom 44% received BB. The BB+ group had significantly lower mortality relative to the BB- group (18.6% vs. 4.4%, p = 0.012). On regression analysis, propranolol had a significant protective effect on in-hospital mortality (adj. IRR 0.32, p = 0.04) and functional outcome at 6-month follow-up (GOS-E ≥ 5 adj. IRR 1.2, p = 0.02). CONCLUSION:Propranolol decreases in-hospital mortality and improves long-term functional outcome in isolated severe TBI. This randomized trial speaks in favor of routine administration of beta-blocker therapy as part of a standardized neurointensive care protocol. LEVEL OF EVIDENCE: Level II; therapeutic. STUDY TYPE: Therapeutic study.
RCT Entities:
BACKGROUND: Observational studies have demonstrated improved outcomes in TBIpatients receiving in-hospital beta-blockers. The aim of this study is to conduct a randomized controlled trial examining the effect of beta-blockers on outcomes in TBIpatients. METHODS: Adult patients with severe TBI (intracranial AIS ≥ 3) were included in the study. Hemodynamically stable patients at 24 h after injury were randomized to receive either 20 mg propranolol orally every 12 h up to 10 days or until discharge (BB+) or no propranolol (BB-). Outcomes of interest were in-hospital mortality and Glasgow Outcome Scale-Extended (GOS-E) score on discharge and at 6-month follow-up. Subgroup analysis including only isolated severe TBI (intracranial AIS ≥ 3 with extracranial AIS ≤ 2) was carried out. Poisson regression models were used. RESULTS: Two hundred nineteen randomized patients of whom 45% received BB were analyzed. There were no significant demographic or clinical differences between BB+ and BB- cohorts. No significant difference in in-hospital mortality (adj. IRR 0.6 [95% CI 0.3-1.4], p = 0.2) or long-term functional outcome was measured between the cohorts (p = 0.3). One hundred fifty-four patients suffered isolated severe TBI of whom 44% received BB. The BB+ group had significantly lower mortality relative to the BB- group (18.6% vs. 4.4%, p = 0.012). On regression analysis, propranolol had a significant protective effect on in-hospital mortality (adj. IRR 0.32, p = 0.04) and functional outcome at 6-month follow-up (GOS-E ≥ 5 adj. IRR 1.2, p = 0.02). CONCLUSION:Propranolol decreases in-hospital mortality and improves long-term functional outcome in isolated severe TBI. This randomized trial speaks in favor of routine administration of beta-blocker therapy as part of a standardized neurointensive care protocol. LEVEL OF EVIDENCE: Level II; therapeutic. STUDY TYPE: Therapeutic study.
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Authors: Ahmad Mohammad Ismail; Tomas Borg; Gabriel Sjolin; Arvid Pourlotfi; Sebastian Holm; Yang Cao; Per Wretenberg; Rebecka Ahl; Shahin Mohseni Journal: Trauma Surg Acute Care Open Date: 2020-07-29
Authors: Alfonso J Lopez; Mohamed ElSaadani; Christina L Jacovides; Anastasia Georges; Matthew C Culkin; Syed Ahmed; Monisha A Kumar; Lewis J Kaplan; Douglas H Smith; Jose L Pascual Journal: J Trauma Acute Care Surg Date: 2022-01-18 Impact factor: 3.697