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

University of Sarajevo

Status: Completed

Conditions: Subarachnoid Hemorrhage; Brain Injuries

Treatments: Procedure: Cerebral perfusion pressure-targeted therapy; Procedure: Modified Lund concept

Study type: Interventional

Funder types: Other

Identifiers

NCT01206283

030531674

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Cerebral perfusion pressure-targeted

Active Comparator group

Description:

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.

Treatment:

Procedure: Cerebral perfusion pressure-targeted therapy

Intracranial pressure-targeted therapy

Active Comparator group

Treatment:

Procedure: Modified Lund concept