Surgery versus conservative treatment for traumatic acute subdural haematoma: a prospective, multicentre, observational, comparative effectiveness study

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  • Thomas A. van Essen
  • Hester F. Lingsma
  • Dana Pisică
  • Ranjit D. Singh
  • Victor Volovici
  • Hugo F. den Boogert
  • Alexander Younsi
  • Lianne D. Peppel
  • Majanka H. Heijenbrok-Kal
  • Gerard M. Ribbers
  • Robert Walchenbach
  • David K. Menon
  • Peter Hutchinson
  • Bart Depreitere
  • Ewout W. Steyerberg
  • Andrew I.R. Maas
  • Godard C.W. de Ruiter
  • Wilco C. Peul
  • Cecilia Åkerlund
  • Krisztina Amrein
  • Nada Andelic
  • Lasse Andreassen
  • Audny Anke
  • Anna Antoni
  • Gérard Audibert
  • Philippe Azouvi
  • Maria Luisa Azzolini
  • Ronald Bartels
  • Pál Barzó
  • Romuald Beauvais
  • Ronny Beer
  • Bo Michael Bellander
  • Antonio Belli
  • Habib Benali
  • Maurizio Berardino
  • Luigi Beretta
  • Morten Blaabjerg
  • Peter Bragge
  • Alexandra Brazinova
  • Vibeke Brinck
  • Joanne Brooker
  • Camilla Brorsson
  • Andras Buki
  • Monika Bullinger
  • Manuel Cabeleira
  • Alessio Caccioppola
  • Emiliana Calappi
  • Maria Rosa Calvi
  • Fabricius, Martin Ejler
  • Kondziella, Daniel
  • CENTER-TBI Collaboration Group

Background: Despite being well established, acute surgery in traumatic acute subdural haematoma is based on low-grade evidence. We aimed to compare the effectiveness of a strategy preferring acute surgical evacuation with one preferring initial conservative treatment in acute subdural haematoma. Methods: We did a prospective, observational, comparative effectiveness study using data from participants enrolled in the Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) cohort. We included patients with no pre-existing severe neurological disorders who presented with acute subdural haematoma within 24 h of traumatic brain injury. Using an instrumental variable analysis, we compared outcomes between centres according to treatment preference for acute subdural haematoma (acute surgical evacuation or initial conservative treatment), measured by the case-mix-adjusted percentage of acute surgery per centre. The primary endpoint was functional outcome at 6 months as rated with the Glasgow Outcome Scale Extended, which was estimated with ordinal regression as a common odds ratio (OR) and adjusted for prespecified confounders. Variation in centre preference was quantified with the median OR (MOR). CENTER-TBI is registered with ClinicalTrials.gov, number NCT02210221, and the Resource Identification Portal (Research Resource Identifier SCR_015582). Findings: Between Dec 19, 2014 and Dec 17, 2017, 4559 patients with traumatic brain injury were enrolled in CENTER-TBI, of whom 1407 (31%) presented with acute subdural haematoma and were included in our study. Acute surgical evacuation was done in 336 (24%) patients, by craniotomy in 245 (73%) of those patients and by decompressive craniectomy in 91 (27%). Delayed decompressive craniectomy or craniotomy after initial conservative treatment (n=982) occurred in 107 (11%) patients. The percentage of patients who underwent acute surgery ranged from 5·6% to 51·5% (IQR 12·3–35·9) between centres, with a two-times higher probability of receiving acute surgery for an identical patient in one centre versus another centre at random (adjusted MOR for acute surgery 1·8; p<0·0001]). Centre preference for acute surgery over initial conservative treatment was not associated with improvements in functional outcome (common OR per 23·6% [IQR increase] more acute surgery in a centre 0·92, 95% CI 0·77–1·09). Interpretation: Our findings show that treatment for patients with acute subdural haematoma with similar characteristics differed depending on the treating centre, because of variation in the preferred approach. A treatment strategy preferring an aggressive approach of acute surgical evacuation over initial conservative treatment was not associated with better functional outcome. Therefore, in a patient with acute subdural haematoma for whom a neurosurgeon sees no clear superiority for acute surgery over conservative treatment, initial conservative treatment might be considered. Funding: The Hersenstichting Nederland (also known as the Dutch Brain Foundation), the European Commission Seventh Framework Programme, the Hannelore Kohl Stiftung (Germany), OneMind (USA), Integra LifeSciences Corporation (USA), and NeuroTrauma Sciences (USA).

OriginalsprogEngelsk
TidsskriftThe Lancet Neurology
Vol/bind21
Udgave nummer7
Sider (fra-til)620-631
Antal sider12
ISSN1474-4422
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
The authors' work on this study is funded by the Hersenstichting Nederland (the Dutch Brain Foundation, grant number ps2014.06) for the Dutch Neurotraumatology Quality Registry 19 and the EU seventh Framework Programme (grant 602150) for CENTER-TBI. Additional support for CENTER-TBI was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from NeuroTrauma Sciences (USA). We thank all patients for their participation in the CENTER-TBI study; and all principal investigators and researchers for their collaboration and support.

Funding Information:
The authors' work on this study is funded by the Hersenstichting Nederland (the Dutch Brain Foundation, grant number ps2014.06) for the Dutch Neurotraumatology Quality Registry 19 and the EU seventh Framework Programme (grant 602150) for CENTER-TBI. Additional support for CENTER-TBI was obtained from the Hannelore Kohl Stiftung (Germany), from OneMind (USA), from Integra LifeSciences Corporation (USA), and from NeuroTrauma Sciences (USA). We thank all patients for their participation in the CENTER-TBI study; and all principal investigators and researchers for their collaboration and support.

Funding Information:
AIRM declares consulting fees from PresSura Neuro, Integra Life Sciences, and NeuroTrauma Sciences. DKM reports grants from the UK National Institute for Health Research, during the conduct of the study; grants, personal fees, and non-financial support from GlaxoSmithKline; and personal fees from Neurotrauma Sciences, Lantmaanen AB, Pressura, and Pfizer, outside of the submitted work. EWS reports personal fees from Springer during the conduct of the study. All other authors declare no competing interests.

Publisher Copyright:
© 2022 Elsevier Ltd

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