Journal Club:Journal Club:

The ED Management of The ED Management of Intracerebral Hemorrhage Intracerebral Hemorrhage

PatientsPatients

Nils G. Wahlgren, MD, PhD

Nils G. WahlgrenNils G. Wahlgren, MD, PhD, MD, PhD

AssociateAssociate ProfessorProfessor

Clinical NeuroscienceClinical NeuroscienceKarolinska InstitutetKarolinska InstitutetStockholm, SwedenStockholm, Sweden

Nils G. Wahlgren, MD, PhD

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

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

Nils G. Wahlgren, MD, PhD

Nils G. Wahlgren, MD, PhD

Nils G. Wahlgren, MD, PhD

Nils G. Wahlgren, MD, PhD

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).

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.

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.

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)

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.

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.

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.

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.

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)

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

Nils G. Wahlgren, MD, PhD

Strategies to reduce acute lesion

Stroke Units

Thrombolysis

Hemostasis

Hemicraniectomy

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

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

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

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

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

Nils G. Wahlgren, MD, PhD

SITS International

Broad implementation

Am

plificatio

n

The purpose of SITS is two-dimensional

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”

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

Nils G. Wahlgren, MD, PhD

Questions??Questions??

www.strokeupdate.orgwww.strokeupdate.orgwww.acutestroke.orgwww.acutestroke.org

Nils WahlgrenNils Wahlgren, MD, PhD, MD, PhDnils.wahlgren@karolinska.se

ferne_aaem_france_2005_wahlgren_ich_jclub.ppt 04/21/23 01:49 Nils Wahlgren, MD, PhD