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

Addenbrooke's Hospital (UK)0 个研究点目标入组 400 人开始时间: 2005年11月21日最近更新: 2022年6月20日

适应症

试验速览

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)

•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

•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

发起方

Addenbrooke's Hospital (UK)