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04 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of intracranial pressure (ICP) (www.RESCUEicp.com) |
| ISRCTN | ISRCTN66202560 |
| ClinicalTrials.gov identifier | |
| Public title | Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of intracranial pressure (ICP) (www.RESCUEicp.com) |
| Scientific title | An international prospective multi-centre randomised controlled trial comparing the efficacy of decompressive craniectomy versus optimal medical management for the treatment of refractory intracranial hypertension following brain trauma (www.RESCUEicp.com) |
| Acronym | RESCUEicp Trial |
| Serial number at source | N/A |
| Study hypothesis |
The application of decompressive craniectomy 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 |
| Lay summary | |
| Ethics approval | Added 06/02/2009: Eastern MREC gave approval on the 22nd October 2003 (ref: 03/5/059) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada, China, Czech Republic, Germany, Greece, Italy, Latvia, Malaysia, Russian Federation, Saudi Arabia, Singapore, Spain, Turkey, United Kingdom, United States of America |
| Disease/condition/study domain | Severe traumatic brain injury |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2004 |
| Anticipated end date | 01/01/2010 |
| Status of trial | Completed |
| Patient information material | Information leaflet for relatives of patients at: http://www.rescueicp.com/Information%20sheet.pdf |
| Target number of participants | 200 + 200 (400 total) |
| Interventions | Decompressive craniectomy (surgical procedure) versus maximal medical management (including barbiturates). |
| Primary outcome measure(s) | The primary endpoint will be assessment of outcome at discharge (Glasgow Outcome Score) and 6 months (Extended Glasgow Outcome Score). |
| Secondary outcome measure(s) |
Secondary endpoints will be:
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 |
| Sources of funding |
1. Academy of Medical Sciences (UK)
2. The Health Foundation (UK) |
| Trial website | http://www.RESCUEicp.com |
| Publications | 2005 editorial in http://www.ncbi.nlm.nih.gov/pubmed/15614466 |
| Contact name | Mr Peter Hutchinson |
| Address |
Box 167
Academic Neurosurgery Unit Addenbrooke's Hospital |
| City/town | Cambridge |
| Zip/Postcode | CB2 2QQ |
| Country | United Kingdom |
| Tel | +44 (0)1223 336946 |
| Fax | +44 (0)1223 216926 |
| pjah2@cam.ac.uk | |
| Sponsor | Addenbrooke's Hospital (UK) |
| Address |
Dr Claudia Rizzini
R&D Office Box 146 Addenbrooke's Hospital |
| City/town | Cambridge |
| Zip/Postcode | CB2 2QQ |
| Country | United Kingdom |
| Tel | +44 (0)1223 274 486 |
| rdenquiries@addenbrookes.nhs.uk | |
| Sponsor website: | http://www.addenbrookes.nhs.uk/research/rd_office.html |
| Date applied | 12/09/2005 |
| Last edited | 09/02/2009 |
| Date ISRCTN assigned | 21/11/2005 |
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