Randomised evaluation of surgery with craniectomy for uncontrollable elevation of intracranial pressure
| ISRCTN | ISRCTN66202560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66202560 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/09/2005
- Registration date
- 21/11/2005
- Last edited
- 07/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Following injury to the head, the brain, just like any other part of the body, becomes bruised and swollen. This swelling occurs in the confines of the rigid skull and results in an increase in pressure and reduction in blood and oxygen supply to the brain.
Treatment in the intensive care unit is directed at controlling swelling and pressure and maintaining a good blood and oxygen supply to the brain. There are a number of conventional treatments that are used to achieve this, including the ventilator to support breathing and various drugs to support blood pressure and reduce swelling directly. Whilst these treatments are effective in some patients, others with more severe swelling are at an increased risk. Currently there are two advanced methods to control brain swelling. The first is the use of an operation called a decompressive craniectomy. In this operation a part of the skull bone is removed (front or side) leaving the brain protected by the membranes and scalp. This creates an opening for the brain, helping to control swelling and high pressure. The opening is later repaired using the original bone or a synthetic plate. The second available method is to use strong drugs to control the activity in the brain. The benefit of each of these treatments, and which method is more effective for a particular type of patient, are currently unclear. This study is being conducted to try to find out which is the best method of treatment. We to enrol approximately 400 participants around the world (200 in the group receiving the operation to control the swelling and 200 in the group receiving medical treatment with stronger drugs).
Who can participate?
Participants must have sustained a head injury, be between the ages of 10 and 65 years, with an abnormal CT scan requiring intra-cranial pressure (ICP) monitoring and raised ICP that has not been successfully managed by the initial medical treatment.
What does the study involve?
If the patient requires these more advanced measures to control pressure and swelling, they will be randomly allocated to one of two groups: either the operation to control the swelling or advanced medical treatment. If either treatment is not effective, then the alternative treatment can be provided. A computerised tomography (CT) scan, which uses x-rays and a computer to create detailed images of the inside of your body, will be taken on admission to hospital and before random allocation to one of the two groups (randomisation). These scans are considered routine for this type of injury and pose no additional risk. At 6, 12 and 24 months following the head injury, you will be contacted in order to complete a questionnaire to assess your recovery. This will be done either by post, a telephone call or in the out patient clinic. The questionnaire takes approximately 30 minutes to complete.
What are the possible benefits and risks of participating?
If you chose to participate in the study, or allow your relative to, there may or may not be any direct benefit. Both treatments are considered to be standard treatments for this condition and are used routinely. It is hoped that the information gained from this study can be used in the future to benefit other people with similar conditions.
Where is the study run from?
Cambridge University and Cambridge University Hospitals Foundation Trust, UK.
See participating centres on the study website http://www.rescueicp.com/frameset4.html
When is the study starting and how long is it expected to run for?
The study recruited its first patient in January 2004 and has a projected completion date of December 2014.
Who is funding the study?
National Institute of Health Research (NIHR) and the Medical Research Council (MRC), UK.
Who is the main contact?
Mr Peter Hutchinson
pjah2@cam.ac.uk
Contact information
Scientific
Box 167
Academic Neurosurgery Unit
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 746453 |
|---|---|
| pjah2@cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Information leaflet for relatives of patients at: http://www.rescueicp.com/Information%20sheet.pdf |
| Scientific title | Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intra-Cranial Pressure trial |
| Study acronym | RESCUEicp |
| Study hypothesis | The application of decompressive craniectomy (as a last-tier therapy) to head-injured patients with raised intracranial pressure (ICP) refractory to medical treatment results in improvement in outcome: 1. Decompressive craniectomy results in an improvement in the Extended Glasgow Outcome Score compared to optimal medical treatment 2. Decompressive craniectomy results in an improvement in surrogate endpoint measures (including specific outcome measures [36-item Short Form questionnaire], control of ICP, time in intensive care and time to discharge from the neurosurgical unit) compared to optimal medical treatment More detailed information on the protocol can be found at http://www.rescueicp.com/downloads.html |
| Ethics approval(s) | Eastern MREC, 22/10/2003, ref: 03/5/059 |
| Condition | Severe traumatic brain injury |
| Intervention | Decompressive craniectomy (surgical procedure) versus maximal medical management (including barbiturates). |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 23/05/2016: Extended Glasgow Outcome Scale (GOSE) at 6 months after randomisation Previous primary outcome measures: Assessment of outcome at discharge (Glasgow Outcome Score) and 6 months (Extended Glasgow Outcome Score) |
| Secondary outcome measures | Current secondary outcome measures as of 23/05/2016: 1. GOSE at 12 and 24 months after randomisation 2. Mortality at 6, 12 and 24 months after randomisation 3. SF-36 and SF-10 (below 16 years) questionnaires at 6, 12 and 24 months after randomisation 4. Glasgow Coma Scale (GCS) at discharge from neurosciences hospital 5. Assessment of ICP control 6. Time in intensive care 7. Time to discharge from the neurosciences hospital 8. Detailed health-economic analysis Adverse events will also be reported. Secondary outcome measures from 18/10/2012 to 23/05/2016: 1. EGOS at 12, 24 and 36 months 2. SF 36 at 6, 12 and 24 months with a health economic analysis Original secondary outcome measures until 18/10/2012: 1. Assessment of outcome using the 36-item short form (SF-36) questionnaire 2. Assessment of ICP control 3. Time in intensive care 4. Time to discharge from the neurosurgical unit |
| Overall study start date | 01/01/2004 |
| Overall study end date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | Current inclusion criteria as of 23/05/2016: 1. Patients with head injury 2. Age 10-65 years 3. Abnormal CT scan requiring ICP monitoring with raised ICP (>25mmHg >1 – 12 hours) refractory to initial medical treatment measures 4. Patients may have had an immediate operation for a mass lesion but not a 'decompressive' craniectomy Previous inclusion criteria: 1. Patients aged 10 - 65 years, either sex 2. An abnormal computed tomography (CT) scan of the head 3. Requiring ICP monitoring with raised ICP (greater than 25 mmHg greater than 1 - 12 hours), refractory to initial medical measures 4. Patients may have an immediate operation for a mass lesion but not a decompressive craniectomy 5. Patients who are immunologically, hepatically or renally compromised can be included, but type and extent of their impairment are noted |
| Participant exclusion criteria | Current exclusion criteria as of 23/05/2016: 1. Bilateral fixed and dilated pupils 2. Bleeding diathesis 3. Devastating injury not expected to survive for 24 hours and follow up not possible 4. Patients treated by the Lund protocol are also not eligible Previous exclusion criteria: 1. Bilateral fixed and dilated pupils 2. Bleeding diathesis 3. A devastating injury not expected to survive for 24 hours 4. Follow-up not possible 5. Unable to monitor ICP 6. Patients treated on the Lund protocol 7. Primary decompression 8. Have received barbiturates pre-randomisation 9. Brainstem involvement |
| Recruitment start date | 01/01/2004 |
| Recruitment end date | 31/03/2014 |
Locations
Countries of recruitment
- Brazil
- Canada
- China
- Czech Republic
- England
- Germany
- Greece
- Italy
- Japan
- Latvia
- Malaysia
- Peru
- Russian Federation
- Saudi Arabia
- Singapore
- Spain
- Türkiye
- United Kingdom
- United States of America
Study participating centre
CB2 2QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Samantha Barker
R&D Office
Box 277
Addenbrooke's Hospital
Cambridge
CB2 2QQ
England
United Kingdom
| Phone | +44 (0)1223 349 236 |
|---|---|
| rdenquiries@addenbrookes.nhs.uk | |
| Website | http://www.addenbrookes.nhs.uk/research/rd_office.html |
"ROR" |
https://ror.org/055vbxf86 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Academy of Medical Sciences
- Location
- United Kingdom
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2006 | Yes | No | |
| Results article | results | 22/09/2016 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 01/10/2016 | No | No | |
| Results article | secondary analysis | 06/06/2022 | 07/06/2022 | Yes | No |
Editorial Notes
07/06/2022: Publication reference added.
08/09/2016: Publication reference added.
23/05/2016: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2014 to 31/03/2016.
18/10/2012: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/01/2010 to 31/12/2014.
2. Japan, Brazil and Peru were added to the countries of recruitment.
