A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.

Not Applicable

Completed

• Conditions: Brain Injuries; Subarachnoid Hemorrhage
• Interventions: Procedure: Cerebral perfusion pressure-targeted therapy; Procedure: Modified Lund concept

• Registration Number: NCT01206283
• Lead Sponsor: University of Sarajevo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Last Update Submitted: 2010-09-20
• Study First Posted: 2010-09-21
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with subarachnoid haemorrhage who had anterior circulation aneurysm rupture only
• multiple anterior aneurysm rupture
• severe traumatic brain injury with isolated head injury and intradural focal lesions only

Exclusion Criteria

• Glasgow Outcome Score of 3 with or without brainstem reflexes
• Significant co-morbidities
• posterior circulation aneurysm
• multisystem injuries
• diffuse axonal injuries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebral perfusion pressure-targeted	Cerebral perfusion pressure-targeted therapy	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.
Intracranial pressure-targeted therapy	Modified Lund concept	-

Primary Outcome Measures

Name	Time	Method
Mortality rate	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.

Trial Locations

Locations (1)

Department of Neurosurgery, Clinical Centre University of Sarajevo; 🇧🇦 Sarajevo, Bosnia and Herzegovina