Condition category
Nervous System Diseases
Date applied
31/07/2014
Date assigned
31/07/2014
Last edited
04/12/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
Dr Natalia Igosheva
natalia.igosheva@addenbrookes.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Miss Tapiwa Tungamirai

ORCID ID

Contact details

Cambridge Clinical Trials Unit
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Coton House Level 6
Box 401
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 1223 256624
tapiwa.tungamirai@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RESCUE-ASDH14

Study information

Scientific title

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

Acronym

RESCUE-ASDH

Study hypothesis

Principal research question: does decompressive craniectomy lead to better functional outcomes in comparison to craniotomy for adult head-injured patients undergoing evacuation of an acute subdural haematoma?

Ethics approval

14/NW/1076; First MREC approval date 17/07/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

Following enrolment in the study, suitability for randomisation will be assessed in the operating room by the operating neurosurgeon. A secure web-based randomisation service will be used for the randomisation of suitable patients. The following information will be required in order to randomise a patient: age, best pre-intubation Glasgow Coma Scale (GCS), pre-operative pupillary reactivity, CT findings. Patients unsuitable for randomisation (e.g. when significant brain swelling prevents safe replacement of the piece of skull) will have the operation deemed to be in their best interests by the operating neurosurgeon.
Following discharge from the acute setting (neurosurgical unit), patients will be followed up at 6 and 12 months post-injury with the extended Glasgow Outcome Scale (GOSE) and the EQ-5D questionnaires. Follow-up will be undertaken by postal questionnaires. However, in some cases a structured telephone interview will need to be undertaken by a blinded assessor, for example, if there are practical difficulties with filling in or returning the form

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Extended Glasgow outcome scale; Timepoint(s): at 12 months post-injury

Secondary outcome measures

1. Extended Glasgow outcome scale at 6 months post-injury
2. Quality of life (EQ-5D) at discharge from neurosurgical unit (NSU), 6 and 12 months post-injury
3. Glasgow Coma Scale (GCS) on discharge from the intensive care unit (ICU) and from NSU
4. Length of stay in ICU, neurosurgical and rehabilitation unit
5. Therapy Intensity Level (IMPACT-TBI scale) in the ICU
6. Discharge destination from NSU
7. Mortality
8. Serious adverse events and surgical complications during index admission
9. Cranial surgery within 2 weeks after randomisation
10. Subsequent readmissions to the NSU within the 12 months follow-up period
11. Hydrocephalus requiring shunt insertion within the 12 months follow-up period
12. Healthcare services utilisation over 12 months
13. Detailed economic evaluation

Overall trial start date

01/10/2014

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Participant inclusion criteria as of 04/12/2018:
1. Adult head-injured patients (>16 years)
2. Acute subdural haematoma on CT*
3. The admitting neurosurgeon feels that the haematoma needs to beevacuated with a large bone flap (recommended size ≥11 cm anteroposterior diameter) either by a craniotomy or decompressive craniectomy
*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included

Previous participant inclusion criteria:
1. Adult head-injured patients (>16 years)
2. Acute subdural haematoma on CT*
3. The admitting neurosurgeon feels that the haematoma needs to be evacuated either by a craniotomy or decompressive craniectomy (bone flap at least 11 cm in both instances )*
*Patients with additional lesions (e.g. intracerebral haemorrhage, contusions) can be included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

440; incorporates 10% drop out rate

Participant exclusion criteria

Participant exclusion criteria as of 04/12/2018:
1. Bilateral acute subdural haematomas both requiring evacuation
2. Previous enrolment in the RESCUE-ASDH study
3. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury

Previous participant exclusion criteria:
1. Bilateral unresponsive dilated pupils of ≥5 mm and/or brainstem injuries on CT
2. Uncorrected coagulopathy
3. Bilateral acute subdural haematomas both requiring evacuation
4. Previous enrolment in the RESCUE-ASDH study
5. Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury

Recruitment start date

01/10/2014

Recruitment end date

30/04/2019

Locations

Countries of recruitment

Australia, Canada, Germany, Greece, Hungary, India, Malaysia, Singapore, Spain, United Kingdom, United States of America

Trial participating centre

Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Rd
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way, Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

King's College Hospital
Denmark Hill, Brixton
London
SE5 9RS
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Mindelsohn Way Edgbaston
Birmingham
B15 2TH
United Kingdom

Trial participating centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Salford Royal Hospital
Stott Lane
Manchester
M6 8HD
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Trial participating centre

St Mary's Hospital
Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

The Walton Centre
Lower Lane
Liverpool
L9 7LJ
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Barry Building, Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Queen's Hospital
Rom Valley Way
Romford
RM7 0AG
United Kingdom

Trial participating centre

Royal London Hospital
Whitechapel Road, Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road, Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

University Hospital Coventry
Clifford Bridge Road
Bristol
CV2 2DX
United Kingdom

Trial participating centre

Ninewells Hospital
James Arrott Drive
Dundee
DD2 1SY
United Kingdom

Trial participating centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Royal Preston Hospital
Sharoe Green Lane, Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Singapore General Hospital
Outram Road
Singapore
169608
Singapore

Trial participating centre

Tan Tock Seng Hospital
11 Jln Tan Tock Seng
Singapore
308433
Singapore

Trial participating centre

Beth Israel Deaconess Medical Center
330 Brookline Avenue
Boston
02215
United States of America

Trial participating centre

The University of Texas Southwestern Medical Center
5323 Harry Hines Blvd
Dallas
75390
United States of America

Trial participating centre

University of Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Trial participating centre

Foothills Medical Centre
1403 29 St NW
Calgary
T2N 2T9
Canada

Trial participating centre

Hamilton General Hospital
237 Barton St E
Hamilton
L8L 2X2
Canada

Trial participating centre

Sunnybrook Health Sciences Centre
2075 Bayview Ave
Toronto
M4N 3M5
Canada

Trial participating centre

MedStar Washington Hospital Center
110 Irving St NW
Washington, DC
20010
United States of America

Trial participating centre

University Hospital of Larissa
Mezourlo
Larissa
41110
Greece

Trial participating centre

National Institute of Mental Health and Neurosciences (NIMHANS)
Hosur Road
Bangalore
560029
India

Trial participating centre

Post Graduate Institute of Medical Education and Research (PGIMER)
Sector 12
Chandigarh
160012
India

Trial participating centre

All India Institute of Medical Sciences (AIIMS)
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East
New Delhi
110029
India

Trial participating centre

Technische Universität München
Arcisstraße 21
Munich
80333
Germany

Trial participating centre

Hospital Universitario La Paz
Paseo de la Castellana, 261
Madrid
28046
Spain

Trial participating centre

Littleton Adventist Hospital
7700 S Broadway
Littleton
80122
United States of America

Trial participating centre

The Alfred Hospital
55 Commercial Rd
Melbourne
3004
Australia

Trial participating centre

Hospital Universitario 12 de Octubre
Av. Cordoba
Madrid
28041
Spain

Trial participating centre

Jacobi Medical Center and Montefiore Medical Center
1400 Pelham Parkway, South Bronx
New York
10461
United States of America

Trial participating centre

Queen Elizabeth II Health Sciences Centre
1276 South Park Street
Halifax
B3H 2Y9
Canada

Trial participating centre

University of Pécs
Pécs
-
Hungary

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK); Grant Codes: 12/35/57

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.