Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/09/2005
Date assigned
21/11/2005
Last edited
08/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

http://www.RESCUEicp.com

Contact information

Type

Scientific

Primary contact

Mr Peter Hutchinson

ORCID ID

Contact details

Box 167
Academic Neurosurgery Unit
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 746453
pjah2@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intra-Cranial Pressure trial

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

Eastern MREC, 22/10/2003, ref: 03/5/059

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Information leaflet for relatives of patients at: http://www.rescueicp.com/Information%20sheet.pdf

Condition

Severe traumatic brain injury

Intervention

Decompressive craniectomy (surgical procedure) versus maximal medical management (including barbiturates).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

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, Germany, Greece, Italy, Japan, Latvia, Malaysia, Peru, Russian Federation, Saudi Arabia, Singapore, Spain, Turkey, United Kingdom, United States of America

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Samantha Barker
R&D Office
Box 277
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 349 236
rdenquiries@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.addenbrookes.nhs.uk/research/rd_office.html

Funders

Funder type

Research organisation

Funder name

Academy of Medical Sciences (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

The Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

MRC managed by NIHR on behalf of the MRC-NIHR partnership (UK)

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

2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16671415
2016 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/26972805
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27602507

Publication citations

  1. Protocol

    Hutchinson PJ, Corteen E, Czosnyka M, Mendelow AD, Menon DK, Mitchell P, Murray G, Pickard JD, Rickels E, Sahuquillo J, Servadei F, Teasdale GM, Timofeev I, Unterberg A, Kirkpatrick PJ, Decompressive craniectomy in traumatic brain injury: the randomized multicenter RESCUEicp study (www.RESCUEicp.com)., Acta Neurochir. Suppl., 2006, 96, 17-20.

  2. Statistical analysis plan

    Kolias AG, Adams H, Timofeev I, Czosnyka M, Corteen EA, Pickard JD, Turner C, Gregson BA, Kirkpatrick PJ, Murray GD, Menon DK, Hutchinson PJ, Decompressive craniectomy following traumatic brain injury: developing the evidence base, Br J Neurosurg, 2016, 30, 2, 246-250, doi: 10.3109/02688697.2016.1159655.

Additional files

Editorial Notes

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.