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

Primary Purpose

Brain Injuries, Subarachnoid Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Modified Lund concept
Cerebral perfusion pressure-targeted therapy
Sponsored by
University of Sarajevo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring traumatic brain injury, subarachnoid hemorrhage, secondary brain ischemia, microdialysis, modified Lund concept, cerebral perfusion pressure, intracranial pressure

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurosurgery, Clinical Centre University of Sarajevo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cerebral perfusion pressure-targeted

Intracranial pressure-targeted therapy

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2010
Last Updated
September 20, 2010
Sponsor
University of Sarajevo
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1. Study Identification

Unique Protocol Identification Number
NCT01206283
Brief Title
A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.
Official Title
Modified Lund Concept Versus Cerebral Perfusion Pressure-targeted Therapy: A Randomized Controlled Study in Patients With Secondary Brain Ischaemia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sarajevo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Subarachnoid Hemorrhage
Keywords
traumatic brain injury, subarachnoid hemorrhage, secondary brain ischemia, microdialysis, modified Lund concept, cerebral perfusion pressure, intracranial pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebral perfusion pressure-targeted
Arm Type
Active Comparator
Arm 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.
Arm Title
Intracranial pressure-targeted therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Modified Lund concept
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cerebral perfusion pressure-targeted therapy
Intervention Description
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]);
Primary Outcome Measure Information:
Title
Mortality rate
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemal Dizdarevic, MD, MSc, PhD
Organizational Affiliation
Department of Neurosurgery, Clinical Centre University of Sarajevo, Sarajevo, Bosnia and Herzegovina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Clinical Centre University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Learn more about this trial

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

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