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Systematic review of current randomised control trials in chronic subdural haematoma and proposal for an international collaborative approach

Abstract

Background

Chronic subdural haematoma (CSDH) is a pathology that is frequently encountered by neurosurgeons. Nevertheless, there is a lack of guidelines based on solid evidence. There has been a recent and considerable increase in the interest on management and outcomes for CSDH. Therefore, we systematically reviewed all currently running randomised controlled trials (RCTs) in chronic subdural haematoma to understand the areas under investigation and plan future collaborative trials.

Methods

Clinical trials databases (Cochrane Controlled Register of Trials, WHO ICTRP and clinical trials.gov) were searched for trials relevant to chronic subdural haematoma. It was then established which trials were currently running and fulfilled robust research methodology for a RCT.

Results

There are 26 currently running RCTs in CSDH, with the most common topics covering application of steroids (7), surgical techniques (5) and tranexamic acid (5). Further to this, there are trials running on other pharmacological agents (4), middle meningeal artery (MMA) embolisation (2) and peri-operative management (3).

Conclusions

Pharmacological agents are a particular focus of CSDH management currently, and a wealth of studies on steroids will hopefully lead to more harmonised, evidence-based practice regarding this in the near future. Surgical techniques and new procedures such as MMA embolisation are also important focuses for improving patient outcomes. There is an on-going need for future RCTs and evidence-based guidelines in CSDH, particularly including low- and middle-income countries, and it is hoped that the establishment of the iCORIC (International COllaborative Research Initiative on Chronic Subdural Haematoma) will help address this.

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Abbreviations

CODE:

Core outcomes and common data elements

CSDH:

Chronic subdural haematoma

CT:

Computed tomography

iCORIC:

International COllaborative Research Initiative on CSDH

Dex/DXM:

Dexamethasone

EANS:

European Association of Neurological Societies

LMIC:

Low- and middle-income countries

MMA:

Middle meningeal artery

RCT:

Randomised controlled trial

TDC:

Twist drill craniostomy

TXA:

Tranexamic acid

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Acknowledgements

International Collaborative Research Initiative on Chronic Subdural Haematoma (iCORIC) study group

E Edlmann (University Hospitals Plymouth NHS Trust, UK & University of Cambridge, UK)

DC Holl (Erasmus Medical Centre, The Netherlands)

HF Lingsma (Erasmus Medical Centre, The Netherlands)

J Bartek Jr (Karolinska University Hospital, Sweden, and Copenhagen University Hospital Rigshospitalet, Denmark)

A Bartley (Sahlgrenska University Hospital, Sweden)

J Duerinck (University Hospital Brussels, Belgium)

TSR Jensen (Copenhagen University Hospital, Denmark)

J Soleman (University Hospital of Basel and University of Basel, Switzerland)

NC Shanbhag (National Institute of Mental Health and Neurosciences, India)

B Indira Devi (National Institute of Mental Health and Neurosciences, India)

T Laeke (Addis Ababa University, Ethiopia)

AM Rubiano (El Bosque University, Colombia)

K Fugleholm (Copenhagen University Hospital, Denmark)

J van der Veken (University Hospital Brussels, Belgium)

M Tisell (Sahlgrenska University Hospital, Sweden)

R Dammers (Erasmus Medical Centre, The Netherlands)

PJ Hutchinson (University of Cambridge, UK)

AG Kolias (University of Cambridge, UK)

C Iorio-Morin (University of Sherbrooke, Canada)

L Marshman (James Cook University, Australia)

W Poon (The Chinese University of Hong Kong, China)

V Smita (Sree Chitra Tirunal Institute for Medical Sciences and Technology, India)

S Sousa (University of Porto, Portugal)

MN Stienen (University of Zurich, Switzerland)

Y Tian (Tianjin Medical University, China)

NA van der Gaag (Leiden University Medical Centre, The Netherlands)

D Verbaan (Amsterdam University Medical Centre, The Netherlands)

Funding

No funding was received for this work, but individual funding acknowledgements include the following: P Hutchinson, AG Kolias and AM Rubiano are supported by the National Institute for Health Research (NIHR) Global Health Research Group on Neurotrauma. The Group was commissioned by the NIHR using Official Development Assistance funding (project 16/137/105). P Hutchinson is also supported by an NIHR Research Professorship, the NIHR Cambridge Biomedical Research Centre, a European Union Seventh Framework Program grant (CENTER-TBI; grant no. 602150), and the Royal College of Surgeons of England.

Author information

Correspondence to E. Edlmann.

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Conflict of interest

Authors E Edlmann, P Hutchinson and A Kolias are involved as investigators with the Dex-CSDH trial (http://www.dexcsdh.org/; accessed 12 Feb. 19). The Dex-CSDH project is funded by the funded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA), project number 13/15/02.

Authors D Holl, R Dammers and H Lingsma are involved as investigators with the DECSA-trial. The DECSA-trial is funded by The Netherlands Organisation for Health Research and Development (ZonMw project number 843002824). The DECSA-trial is part of the Dutch Chronic Subdural Hematoma Research group (DSHR).

Author J Soleman is involved as investigator with the SECA-trial. The SECA-trial is funded by The Swiss National Foundation, the Gottfried und Julia Bangerter-Rhyner-Stiftung, and the Research Foundation University Hospital of Basel.

Collaborator C Iorio-Morin is involved as investigator with the TRACS and EMMACS trials. The TRACS trial is funded by the Fondation NeuroTrauma Marie-Robert (project 2015/11/TRACS).

Authors J Bartek Jr., A Bartley, J Duerinck, TSR Jensen, NC Shanbhag, B Indira Devi, T Laeke, AM Rubiano, K Fugleholm, J van der Veken and M Tisell declare that they have no conflicts of interest.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Edlmann, E., Holl, D.C., Lingsma, H.F. et al. Systematic review of current randomised control trials in chronic subdural haematoma and proposal for an international collaborative approach. Acta Neurochir (2020). https://doi.org/10.1007/s00701-020-04218-8

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Keywords

  • Chronic subdural haematoma
  • Head injury
  • Elderly
  • Collaboration
  • Trials