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Journal Club:Journal Club:
The ED Management of The ED Management of Intracerebral Hemorrhage Intracerebral Hemorrhage
PatientsPatients
Nils G. Wahlgren, MD, PhD
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Nils G. WahlgrenNils G. Wahlgren, MD, PhD, MD, PhD
AssociateAssociate ProfessorProfessor
Clinical NeuroscienceClinical NeuroscienceKarolinska InstitutetKarolinska InstitutetStockholm, SwedenStockholm, Sweden
Nils G. Wahlgren, MD, PhD
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Head of Clinical Stroke ProgrammeHead of Clinical Stroke Programmeand Stroke Research Unitand Stroke Research Unit
Department of NeurologyDepartment of NeurologyKarolinska University HospitalKarolinska University Hospital
Stockholm, SwedenStockholm, Sweden
Nils G. Wahlgren, MD, PhD
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Nils G. Wahlgren, MD, PhD
Objectives for this presentationObjectives for this presentation
• Present a professional reaction to recent publications on management of haemorrhagic stroke
• Present a method for broad implementation of acute stroke treatments
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Nils G. Wahlgren, MD, PhD
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Nils G. Wahlgren, MD, PhD
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Nils G. Wahlgren, MD, PhD
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Nils G. Wahlgren, MD, PhD
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Nils G. Wahlgren, MD, PhD
1. Suspected victims of hemorrhagic stroke should be transported without delay to the nearest hospital providing acute stroke care. Neurointensive care, neuroradiology and neurosurgery services should be available in such hospital (grade C).
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Nils G. Wahlgren, MD, PhD
2. CT scan of the head is the most important diagnostic procedure in the initial evaluation of patients with suspected ICH (grade C). MRI is as accurate as CT examination for the detection of acute ICH (grade A), and it may be better for the detection of chronic ICH.
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Nils G. Wahlgren, MD, PhD
5. Specific treatment of ICH is still controversial. As yet, an advantage of neurosurgical intervention over medical treatment has not been established. In the past, there has not been any RCT on medical treatment for spontaneous ICH. Recently, three RCTs evaluating new strategies for the treatment of the ICH have been completed.
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Nils G. Wahlgren, MD, PhD
5. Three ICH RCTs:a. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial ICH (The International STICH trial);b. Stereotactic aspiration combined with instillation of fibrynolitic agent (The SICHPA trial);c. Ultra-early haemostatic therapy by using the recombinant activated factor VIIa (The Novo-7 trial)
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Nils G. Wahlgren, MD, PhD
5.1. Main results of STICH trial
There is no evidence of an overall benefit of early surgery when compared to initial conservative treatment. One finding in a predefined subgroup, that patients with superficial hematomas might benefit from surgery (craniotomy), needs further exploration.
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Nils G. Wahlgren, MD, PhD
5.2. The result of SICHPA trial
The trial was prematurely stopped because of low recruitment. A cautious conclusion could be made that stereotactic aspiration of supratentorial hematoma after instillation of a plasminogen activator can be performed safely. It may reduce the hematoma volume significantly.
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Nils G. Wahlgren, MD, PhD
5.3. Main results of Novo-7 trial
This was a phase IIb trial which included 400 patients with acute ICH.
Treatment with rFVIIa within 4 hours reduced hematoma expansion, decreased mortality, and improved clinical outcome significantly, despite slight increase in the risk of thromboembolic events. A phase III trial is needed to confirm the beneficial effect of rFVIIa in acute ICH.
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Nils G. Wahlgren, MD, PhD
6. Further statements regarding surgical evacuation (all grade C):
a. In cerebellar hemorrhage > 3cm in diameter with hydrocephalus, neurological deterioration or brainstem compression, surgical evacuation should be performed urgently.
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Nils G. Wahlgren, MD, PhD
6. Further statements regarding surgical evacuation (all grade C):
b. Intraventricular ICH plus hydrocephalus should be treated with ventricular drainage.
c. In supratentorial hemorrhages consider removal of clots if there is deterioration from GCS 9–12, or if ICP rises
by craniotomy if superficial (within 1 cm of cortical surface)
by aspiration if deep (need more trials)
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Nils G. Wahlgren, MD, PhD
European dilemma:
1,000,000 strokes/year
500,000 ’independent’after 12 months
200,000 die < 12 months
300,000 ’dependent’after 1 year55 billi
on Euro
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Nils G. Wahlgren, MD, PhD
Strategies to reduce acute lesion
Stroke Units
Thrombolysis
Hemostasis
Hemicraniectomy
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Nils G. Wahlgren, MD, PhD
Several interventions are proven efficacious, but:
What good is that the results from Randomised Controlled Trials are forgotten in the Archives?
Stroke Units UNDERUSED
Thrombolysis
Anticoagulationin AF
Carotid surgery
UNDERUSED
UNDERUSED
UNDERUSED
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Nils G. Wahlgren, MD, PhD
The appropriateness of randomised controlled trials or quality The appropriateness of randomised controlled trials or quality monitoring registers depend on level of evidence for a treatmentmonitoring registers depend on level of evidence for a treatment
Evidence for effect and safety of treatment
Unclear
Clear
• Inherent risks with treatment, e.g. bleedings
• Potential for continuous improvement
• Treatment new to many
• None of above
Randomised controlled trials
Safety/ quality monitoring
No monitoring needed
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Nils G. Wahlgren, MD, PhD
Maps courtesy of www.theodora.com/maps used with permission
324 active centres in 24 countriesplus >60 centres, 2 countries pending
5442 patients (June 29, 2005)
Scientific CommitteeBrain Imaging CommitteeNational CommitteesNational & Local Coordinators
>1000 users of the SITS database
Safe Implementation of Thrombolysis in Stroke (SITS)
• International network of medical professionals dedicated to safe implementation of thrombolysis using the International Stroke Thrombolysis Register (SITS-ISTR) as a tool
• Conducts a safety monitoring study (SITS-MOST) to ensure safe broad implementation and permanent licence in European Union
SITS is an academic initiative to support implementation of stroke SITS is an academic initiative to support implementation of stroke treatment – so far within thrombolysis but big overlap with haemorrhage treatment – so far within thrombolysis but big overlap with haemorrhage
managementmanagement
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Nils G. Wahlgren, MD, PhD
Maps courtesy of www.theodora.com/maps used with permission
SITS is an academic initiative to support implementation of stroke SITS is an academic initiative to support implementation of stroke treatment – thrombolysis and haemostasistreatment – thrombolysis and haemostasis
Baseline + results data for rt-PA treatedpatients
Immediatestatistical report • Centre• Country• Total
FeedbackImproved effectImproved safety
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Nils G. Wahlgren, MD, PhD
Recruitment in SITS is now (Aug 05) >6000 patients Recruitment in SITS is now (Aug 05) >6000 patients in 324 active centers – great potential for rapid treatment in 324 active centers – great potential for rapid treatment
implementationimplementation
Patients recruited Centers recruited
2003 2004 2005
0
1000
2000
3000
4000
5000
6000
0
50
100
150
200
250
300
350
Centres
Patients
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Nils G. Wahlgren, MD, PhD
SITS International
Broad implementation
Am
plificatio
n
The purpose of SITS is two-dimensional
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Nils G. Wahlgren, MD, PhD
The proportion of SITS-MOST centres with no previous experience of The proportion of SITS-MOST centres with no previous experience of thrombolysis is growingthrombolysis is growing
Number of centers
1. Experienced center: Participated in ECASS I/II or treated at least 5 patients before joining SITS. New Center: No such experience
17%
37%
51%
100%=6 100%=139 100%=311
Experienced centers1
New centers1
Jan 2003 Dec 2003 Dec 2004
SITS-MOST reaches non-expert centers that might not otherwise dare to start
“Without the support and scientific approach from SITS we would not have dared to start thrombolysis treatment here”
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Nils G. Wahlgren, MD, PhD
ConclusionsConclusions
• Karolinska Stroke Update: NovoSeven is very promising for treatment of haemorrhagic stroke
• SITS International – professional network is an effective instrument for broad imlementation of management of haemorrhagic stroke
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Nils G. Wahlgren, MD, PhD
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Questions??Questions??
www.strokeupdate.orgwww.strokeupdate.orgwww.acutestroke.orgwww.acutestroke.org
Nils WahlgrenNils Wahlgren, MD, PhD, MD, [email protected]
ferne_aaem_france_2005_wahlgren_ich_jclub.ppt 04/21/23 01:49 Nils Wahlgren, MD, PhD