Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)

Plain English Summary

Plain English summary as of 04/12/2018:
Background and study aims
It is estimated that 4,000 head-injured patients have emergency brain surgery each year in the NHS. Two-thirds of head-injured patients requiring emergency surgery have a blood clot between the outer lining of the brain and the brain itself. This is called an acute subdural haematoma (ASDH). The pressure this clot puts on the brain can be life threatening, so an urgent operation is needed to remove it. When an ASDH is surgically removed, a piece of skull can be left out or replaced before closing the skin. When a piece of skull is replaced before closing the skin, the operation is named craniotomy. On the other hand, when a piece of skull is left out, the operation is named decompressive craniectomy (DC). The advantage of a DC is that it is more effective in controlling brain swelling, which is often a problem in the days after the operation. After a few months, the patient has another operation to rebuild the skull (with the patient's own bone or an artificial material). The advantage of a craniotomy is that the patient will not need a later operation to rebuild the skull. However, craniotomy may fail to control the brain swelling in some patients. All neurosurgeons are capable of performing both types of operation. Currently, there is no high-quality evidence showing if one operation is better than the other. This study aims to provide this much needed evidence.

Who can participate?
Adult patients with head injuries and acute subdural haematoma can take part.

What does the study involve?
Patients will be randomly allocated to one of the two above mentioned treatments. Participants of the study will fill in a short questionnaire at 6 months and 12 months after the initial injury – this is the only additional thing they will be asked to do. This questionnaire will help us find out about their recovery.

What are the possible benefits and risks of participating?
There are no direct benefits for study participants. However, the study may help doctors in the future decide which operation to use for patients who sustain severe brain injury with an acute subdural haematoma. Both types of operation are currently carried out routinely for patients with ASDH. The risks to participants are minimal. If there is a significant brain swelling preventing safe replacement of the bone flap, the patient will not be allocated but will have the bone flap left out as per standard clinical practice. Moreover, patients allocated to undergo craniotomy who go on to develop brain swelling due to their underlying injury will be allowed to return to the operating theatre to have the bone flap removed if this is deemed necessary by the clinical team.

Where is the study run from?
The lead site is Addenbrookes Hospital, Cambridge. Recruitment will be taking place across UK and international sites.

When is the study starting and how long is it expected to run for?
The study will start in October 2014 and will run until April 2020.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Miss Tapiwa Tungamirai
tapiwa.tungamirai@addenbrookes.nhs.uk


Previous plain English summary:
Background and study aims
It is estimated that 4,000 head-injured patients have emergency brain surgery each year in the NHS. Two-thirds of head-injured patients requiring emergency surgery have a blood clot between the outer lining of the brain and the brain itself. This is called an acute subdural haematoma (ASDH). The pressure this clot puts on the brain can be life threatening, so an urgent operation is needed to remove it. When an ASDH is surgically removed, a piece of skull can be left out or replaced before closing the skin. When a piece of skull is replaced before closing the skin, the operation is named craniotomy. On the other hand, when a piece of skull is left out, the operation is named decompressive craniectomy (DC). The advantage of a DC is that it is more effective in controlling brain swelling, which is often a problem in the days after the operation. After a few months, the patient has another operation to rebuild the skull (with the patient's own bone or an artificial material). The advantage of a craniotomy is that the patient will not need a later operation to rebuild the skull. However, craniotomy may fail to control the brain swelling in some patients. All neurosurgeons are capable of performing both types of operation. Currently, there is no high-quality evidence showing if one operation is better than the other. This study aims to provide this much needed evidence.

Who can participate?
Adult patients with head injuries and acute subdural haematoma can take part.

What does the study involve?
Patients will be randomly allocated to one of the two above mentioned treatments. Participants of the study will fill in a short questionnaire at 6 months and 12 months after the initial injury – this is the only additional thing they will be asked to do. This questionnaire will help us find out about their recovery.

What are the possible benefits and risks of participating?
There are no direct benefits for study participants. However, the study may help doctors in the future decide which operation to use for patients who sustain severe brain injury with an acute subdural haematoma. Both types of operation are currently carried out routinely for patients with ASDH. The risks to participants are minimal. If there is a significant brain swelling preventing safe replacement of the bone flap, the patient will not be allocated but will have the bone flap left out as per standard clinical practice. Moreover, patients allocated to undergo craniotomy who go on to develop brain swelling due to their underlying injury will be allowed to return to the operating theatre to have the bone flap removed if this is deemed necessary by the clinical team.

Where is the study run from?
The list will be updated later once more sites join the study. Following are the study sites in the UK:
1. Addenbrooke’s Hospital, Cambridge
2. Derriford Hospital, Plymouth
3. John Radcliffe Hospital, Oxford
4. King's College Hospital, London
5. Leeds General Infirmary, Leeds
6. Queen Elizabeth Hospital, Birmingham
7. Royal Hallamshire Hospital, Sheffield
8. Salford Royal Hospital, Manchester
9. Southampton General Hospital, Southampton
10. St George's Hospital, London
11. St Mary’s Hospital, London
12. The Walton Centre, Liverpool

When is the study starting and how long is it expected to run for?
The study will start in October 2014 and will run until June 2020.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Carol Davis-Wilkie, carol.daviswilkie@addenbrookes.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Australia
• Canada
• England
• Germany
• Greece
• Hungary
• India
• Italy
• Malaysia
• Pakistan
• Scotland
• Singapore
• Spain
• United Kingdom
• United States of America
• Wales

Study participating centres

Sponsor information

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)
Hospital/treatment centre

Research Services Department
Box 277
Addenbrooke’s Hospital Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN87370545_ResultsPlainEnglish.pdf

Editorial Notes

25/06/2024: Publication reference added.
20/11/2023: The following changes have been made:
1. A lay summary of results has been uploaded.
2. The IRAS number has been added.
25/04/2023: Publication reference added.
24/09/2019: The trial contact has been changed from Tapiwa Tungamirai to Carol Davis-Wilkie.
21/05/2019: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was added.
3. Pakistan and Italy were added to countries of recruitment.
4. 5 trial participating centres were added.
03/04/2019: The condition has been changed from "Topic: Injuries and emergencies, Neurological disorders, Surgery; Subtopic: Injuries and Emergencies (all Subtopics), Neurological (all Subtopics), Surgery; Disease: Injuries and Emergencies, Nervous system disorders, All Surgery" to "Acute subdural haematoma" following a request from the NIHR.
04/12/2018: The following changes were made:
1. The plain English summary was updated.
2. The protocol/serial number was updated from 17080 to RESCUE-ASDH14.
3. The overall trial end date was changed from 30/06/2020 to 30/04/2020.
4. The participant inclusion criteria was updated.
5. The target number of participants was changed from 990 to 440.
6. The participant exclusion criteria was updated.
7. The recruitment end date was changed from 30/06/2020 to 30/04/2019.
8. The countries of recruitment were updated.
9. The trial participating centres were updated.
19/04/2017: The contact has been updated from Natalia Igosheva to Tapiwa Tungamirai.