A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.
|ClinicalTrials.gov Identifier: NCT01206283|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : September 21, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries Subarachnoid Hemorrhage||Procedure: Modified Lund concept Procedure: Cerebral perfusion pressure-targeted therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||July 2008|
Active Comparator: Cerebral perfusion pressure-targeted
15 comatose operated patients after aneurysmal subarachnoid haemorrhage and severe traumatic brain injury respectively were managed postoperatively using cerebral perfusion pressure-targeted therapy according to the American Associations of Neurological Surgeons. Results were categorised into different Glasgow Outcome Scores.
Procedure: Cerebral perfusion pressure-targeted therapy
|Active Comparator: Intracranial pressure-targeted therapy||
Procedure: Modified Lund concept
After surgical evacuation of intracranial mass lesion and clipping of aneurysm the objectives were achieved:
- Mortality rate [ Time Frame: 18 months ]Measurement of outcome was done using the Glasgow Outcome Scale (GOS) after each specific intervention in all the patients. GOS 1 - dead, 2- vegetative, 3- severe disabled, 4- moderate disabled, 5- independent.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206283
|Bosnia and Herzegovina|
|Department of Neurosurgery, Clinical Centre University of Sarajevo|
|Sarajevo, Bosnia and Herzegovina, 71000|
|Principal Investigator:||Kemal Dizdarevic, MD, MSc, PhD||Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina|