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

NCT01206283 | Completed DMC

• 1 other identifier: 030531674
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Injuries; Subarachnoid Hemorrhage

Keywords

traumatic brain injury; subarachnoid hemorrhage; secondary brain ischemia; microdialysis; modified Lund concept; cerebral perfusion pressure; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  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.

  18 months

Study Arms (2)

Cerebral perfusion pressure-targeted

ACTIVE COMPARATOR

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

Intracranial pressure-targeted therapy

ACTIVE COMPARATOR

Procedure: Modified Lund concept

Interventions

Modified Lund concept PROCEDURE

After surgical evacuation of intracranial mass lesion and clipping of aneurysm the objectives were achieved: * Reduction of cerebral energy metabolism with fentanyl (2-5 µg/kg/h) and thiopenthal (0.5-3 mg/kg/h); * Maintenance of colloid osmotic pressure with administration of red cell and albumin/plasma transfusions to maintain Hb/s 125-140 g/L and Alb/s ≈40 g/L; * Reduction of capillary hydrostatic pressure with α2-agonist clonidine (0.4-0.8 µg/kg, 1 x 4-6 iv.) and maintaining normovolaemia; * Reduction of mean arterial pressure and neuroprotection with Nimodipine infusion 5 ml per hour for 21 days and Urapidil 200 mg /200 ml, 7-10 ml/h. * Control of ICP, which can be in majority of patients, kept at values below 15 mmHg.

Intracranial pressure-targeted therapy

Cerebral perfusion pressure-targeted therapy PROCEDURE

* ICP monitoring using an external ventricular drain and CSF drainage as a first measure if ICP was increased (over 15-20 mmHg); * Maintenance of CPP over 70-80 mmHg (Triple 'H' therapy = 3L/24 hours including 1L of colloids - 5% albumin; drugs = dopamine, dobutamine); * No hyperventilation if ICP was under 20-25 mmHg and hyperventilation as a third measure if ICP was increased; * Osmotherapy (20% manitol, bolus 150-350 ml or 10% manitol, 50 ml/h for 10 hours and standard electrolytes \[Na, Cl and K\]);

Cerebral perfusion pressure-targeted

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sarajevo: lead

Study Sites (1)

Department of Neurosurgery, Clinical Centre University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

MeSH Terms

Conditions

Brain Injuries; Subarachnoid Hemorrhage; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kemal Dizdarevic, MD, MSc, PhD

  Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 21, 2010
• Study Start: January 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

BO (1)