Condition category
Nervous System Diseases
Date applied
31/07/2014
Date assigned
31/07/2014
Last edited
15/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Scientific

Primary contact

Dr Natalia Igosheva

ORCID ID

Contact details

Cambridge Clinical Trials Unit
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Box 401
Hills Road
Cambridge
CB2 0QQ
United Kingdom
natalia.igosheva@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17080

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 measures

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

30/06/2020

Reason abandoned

Eligibility

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

990; incorporates 10% drop out rate

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

30/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridge Clinical Trials Unit
Cambridge
CB2 0QQ
United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes