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Randomized Controlled Trial
. 2022 Jul 1;79(7):664-671.
doi: 10.1001/jamaneurol.2022.1070.

Evaluation of Outcomes Among Patients With Traumatic Intracranial Hypertension Treated With Decompressive Craniectomy vs Standard Medical Care at 24 Months: A Secondary Analysis of the RESCUEicp Randomized Clinical Trial

Angelos G Kolias  1   2 , Hadie Adams  1   2 , Ivan S Timofeev  1   2 , Elizabeth A Corteen  1   2 , Iftakher Hossain  1   2 , Marek Czosnyka  2 , Jake Timothy  3 , Ian Anderson  3 , Diederik O Bulters  4 , Antonio Belli  5 , C Andrew Eynon  4 , John Wadley  6 , A David Mendelow  7 , Patrick M Mitchell  7 , Mark H Wilson  8 , Giles Critchley  9 , Juan Sahuquillo  10 , Andreas Unterberg  11 , Jussi P Posti  12 , Franco Servadei  13   14 , Graham M Teasdale  15 , John D Pickard  1   2 , David K Menon  1   2 , Gordon D Murray  16 , Peter J Kirkpatrick  1 , Peter J Hutchinson  2 ; RESCUEicp Trial Collaborators
Collaborators, Affiliations
Randomized Controlled Trial

Evaluation of Outcomes Among Patients With Traumatic Intracranial Hypertension Treated With Decompressive Craniectomy vs Standard Medical Care at 24 Months: A Secondary Analysis of the RESCUEicp Randomized Clinical Trial

Angelos G Kolias et al. JAMA Neurol. .

Abstract

Importance: Trials often assess primary outcomes of traumatic brain injury at 6 months. Longer-term data are needed to assess outcomes for patients receiving surgical vs medical treatment for traumatic intracranial hypertension.

Objective: To evaluate 24-month outcomes for patients with traumatic intracranial hypertension treated with decompressive craniectomy or standard medical care.

Design, setting, and participants: Prespecified secondary analysis of the Randomized Evaluation of Surgery With Craniectomy for Uncontrollable Elevation of Intracranial Pressure (RESCUEicp) randomized clinical trial data was performed for patients with traumatic intracranial hypertension (>25 mm Hg) from 52 centers in 20 countries. Enrollment occurred between January 2004 and March 2014. Data were analyzed between 2018 and 2021. Eligibility criteria were age 10 to 65 years, traumatic brain injury (confirmed via computed tomography), intracranial pressure monitoring, and sustained and refractory elevated intracranial pressure for 1 to 12 hours despite pressure-controlling measures. Exclusion criteria were bilateral fixed and dilated pupils, bleeding diathesis, or unsurvivable injury.

Interventions: Patients were randomly assigned 1:1 to receive a decompressive craniectomy with standard care (surgical group) or to ongoing medical treatment with the option to add barbiturate infusion (medical group).

Main outcomes and measures: The primary outcome was measured with the 8-point Extended Glasgow Outcome Scale (1 indicates death and 8 denotes upper good recovery), and the 6- to 24-month outcome trajectory was examined.

Results: This study enrolled 408 patients: 206 in the surgical group and 202 in the medical group. The mean (SD) age was 32.3 (13.2) and 34.8 (13.7) years, respectively, and the study population was predominantly male (165 [81.7%] and 156 [80.0%], respectively). At 24 months, patients in the surgical group had reduced mortality (61 [33.5%] vs 94 [54.0%]; absolute difference, -20.5 [95% CI, -30.8 to -10.2]) and higher rates of vegetative state (absolute difference, 4.3 [95% CI, 0.0 to 8.6]), lower or upper moderate disability (4.7 [-0.9 to 10.3] vs 2.8 [-4.2 to 9.8]), and lower or upper severe disability (2.2 [-5.4 to 9.8] vs 6.5 [1.8 to 11.2]; χ27 = 24.20, P = .001). For every 100 individuals treated surgically, 21 additional patients survived at 24 months; 4 were in a vegetative state, 2 had lower and 7 had upper severe disability, and 5 had lower and 3 had upper moderate disability, respectively. Rates of lower and upper good recovery were similar for the surgical and medical groups (20 [11.0%] vs 19 [10.9%]), and significant differences in net improvement (≥1 grade) were observed between 6 and 24 months (55 [30.0%] vs 25 [14.0%]; χ22 = 13.27, P = .001).

Conclusions and relevance: At 24 months, patients with surgically treated posttraumatic refractory intracranial hypertension had a sustained reduction in mortality and higher rates of vegetative state, severe disability, and moderate disability. Patients in the surgical group were more likely to improve over time vs patients in the medical group.

Trial registration: ISRCTN Identifier: 66202560.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Kolias reported receiving grants from the Medical Research Council during the conduct of the study. Dr Hossain reported receiving the Integra EANS grant from the European Association of Neurosurgical Societies and a research grant from the Finnish Medical Foundation during the conduct of the study. Dr Belli reported receiving grants from the UK National Institute for Health and Care Research (NIHR) during the conduct of the study. Dr Mendelow reported serving as the director of Newcastle Neurosurgery Foundation Ltd outside the submitted work. Dr Posti reported receiving grants from the Academy of Finland and the Maire Taponen Foundation during the conduct of the study. Dr Pickard reported receiving grants from the University of Cambridge during the conduct of the study. Dr Menon reported receiving grants from NIHR during the conduct of the study as well as grants from PressuraNeuro and GlaxoSmithKline and personal fees from Lantmannen AB, NeuroTrauma Sciences, Calico, and Integra Neurosciences (for educational activities) outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram of RESCUEicp Participants
CONSORT indicates Consolidated Standards of Reporting Trials; RESCUEicp, Randomized Evaluation of Surgery With Craniectomy for Uncontrollable Elevation of Intracranial Pressure.
Figure 2.
Figure 2.. Outcome Classifications at 6, 12, and 24 Months for Patients With Traumatic Intracranial Hypertension Treated With Surgery or Standard Medical Care
Patients with severe traumatic brain injury and sustained and refractory intracranial hypertension were randomly assigned 1:1 to decompressive craniectomy with standard care (surgical group) or to ongoing medical treatment with the option to add barbiturate infusion (medical group). Outcomes were assessed using the 8-point Extended Glasgow Outcome Scale (GOS-E), with 1 indicating death and 8 denoting upper good recovery.
See this image and copyright information in PMC

References

    1. Kolias AG, Kirkpatrick PJ, Hutchinson PJ. Decompressive craniectomy: past, present and future. Nat Rev Neurol. 2013;9(7):405-415. doi:10.1038/nrneurol.2013.106 - DOI - PubMed
    1. Kolias AG, Viaroli E, Rubiano AM, et al. . The current status of decompressive craniectomy in traumatic brain injury. Curr Trauma Rep. 2018;4(4):326-332. doi:10.1007/s40719-018-0147-x - DOI - PMC - PubMed
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    1. Hutchinson PJ, Kolias AG, Timofeev IS, et al. ; RESCUEicp Trial Collaborators . Trial of decompressive craniectomy for traumatic intracranial hypertension. N Engl J Med. 2016;375(12):1119-1130. doi:10.1056/NEJMoa1605215 - DOI - PubMed

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