Randomised evaluation of surgery with craniectomy for uncontrollable elevation of intracranial pressure

Not Applicable

Completed

• Conditions: Severe traumatic brain injury; Injury, Occupational Diseases, Poisoning; Brain injury

• Registration Number: ISRCTN66202560
• Lead Sponsor: Addenbrooke's Hospital (UK)

Brief Summary

2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/16671415 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27602507 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35666526/ secondary analysis (added 07/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-21
• Study Completion: 2016-03-31
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified