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

This study has been completed.
Sponsor:
Information provided by:
University of Sarajevo
ClinicalTrials.gov Identifier:
NCT01206283
First received: September 20, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention
Brain Injuries
Subarachnoid Hemorrhage
Procedure: Modified Lund concept
Procedure: Cerebral perfusion pressure-targeted therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.

Resource links provided by NLM:


Further study details as provided by University of Sarajevo:

Primary Outcome Measures:
  • Mortality rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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]);
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:

  • 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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206283

Locations
Bosnia and Herzegovina
Department of Neurosurgery, Clinical Centre University of Sarajevo
Sarajevo, Bosnia and Herzegovina, 71000
Sponsors and Collaborators
University of Sarajevo
Investigators
Principal Investigator: Kemal Dizdarevic, MD, MSc, PhD Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina
  More Information

No publications provided

Responsible Party: Kemal Dizdarevic, Clinical Center University of Sarajevo, Bosnia and Herzegovina
ClinicalTrials.gov Identifier: NCT01206283     History of Changes
Other Study ID Numbers: 030531674
Study First Received: September 20, 2010
Last Updated: September 20, 2010
Health Authority: Bosnia: Federal Ministry of Health

Keywords provided by University of Sarajevo:
traumatic brain injury
subarachnoid hemorrhage
secondary brain ischemia
microdialysis
modified Lund concept
cerebral perfusion pressure
intracranial pressure

Additional relevant MeSH terms:
Brain Ischemia
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Brain Injuries
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 14, 2014