Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01206283
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2010-09-20
Brief Title:
A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia
Sponsor:
University of Sarajevo
Organization:
University of Sarajevo
Study Overview
Official Title:
Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy A Randomized Controlled Study in Patients With Secondary Brain Ischaemia
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Secondary brain ischaemia SBI usually develops after aneurysmal subarachnoid haemorrhage SAH and severe traumatic brain injury TBI The current management strategies are based on intracranial pressure-targeted therapy ICP-targeted with cerebral microdialysis monitoring modified Lund concept or cerebral perfusion pressure-targeted therapy CPP-targeted We present a randomised controlled study to compare the two management strategies
The hypotheses of the study were
SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology
ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI
Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis Outcome for cerebral microdialysis was measured as poor outcome Glasgow Outcome Scale score 1 2 and 3 or good outcome Glasgow Outcome Scale score 4 and 5
The hypotheses of the study were
SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology
ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI
Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis Outcome for cerebral microdialysis was measured as poor outcome Glasgow Outcome Scale score 1 2 and 3 or good outcome Glasgow Outcome Scale score 4 and 5
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None