Journal Club:The ED Management of Intracerebral Hemorrhage Patients Nils G. Wahlgren, MD, PhD
Nils G. Wahlgren, MD, PhDAssociateProfessorClinical NeuroscienceKarolinska InstitutetStockholm, Sweden Nils G. Wahlgren, MD, PhD
Head of Clinical Stroke Programmeand Stroke Research UnitDepartment of NeurologyKarolinska University HospitalStockholm, Sweden Nils G. Wahlgren, MD, PhD
Objectives 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
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).
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.
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.
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)
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.
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.
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.
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.
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)
European dilemma: 1,000,000 strokes/year 500,000 ’independent’ after 12 months 200,000 die < 12 months 300,000 ’dependent’ after 1 year 55 billion Euro
Strategies to reduce acute lesion Stroke Units Thrombolysis Hemostasis Hemicraniectomy
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 UNDERUSED Anticoagulation in AF UNDERUSED UNDERUSED Carotid surgery
The appropriateness of randomised controlled trials or quality monitoring registers depend on level of evidence for a treatment Randomised controlled trials Unclear Evidence for effect and safety of treatment • Inherent risks with treatment, e.g. bleedings • Potential for continuous improvement • Treatment new to many Safety/ quality monitoring Clear No monitoring needed • None of above
SITS is an academic initiative to support implementation of stroke treatment – so far within thrombolysis but big overlap with haemorrhage management 324 active centres in 24 countries plus >60 centres, 2 countries pending 5442 patients (June 29, 2005) Scientific Committee Brain Imaging Committee National Committees National & 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 Maps courtesy of www.theodora.com/maps used with permission
SITS is an academic initiative to support implementation of stroke treatment – thrombolysis and haemostasis Baseline + results data for rt-PA treated patients • Immediate • statistical report • Centre • Country • Total Feedback Improved effect Improved safety Maps courtesy of www.theodora.com/maps used with permission
Recruitment in SITS is now (Aug 05) >6000 patients in 324 active centers – great potential for rapid treatment implementation Patients recruited Centers recruited 2003 2004 2005
The purpose of SITS is two-dimensional SITS International Amplification Broad implementation
The proportion of SITS-MOST centres with no previous experience of thrombolysis is growing Experienced centers1 Number of centers New centers1 100%=311 100%=139 100%=6 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” 51% 37% 17% Jan 2003 Dec 2003 Dec 2004 • Experienced center: Participated in ECASS I/II or treated at least 5 patients before joining SITS. New Center: No such experience
Conclusions • 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
Questions??www.strokeupdate.orgwww.acutestroke.orgNils Wahlgren, MD, PhDnils.email@example.com Nils Wahlgren, MD, PhD ferne_aaem_france_2005_wahlgren_ich_jclub.ppt 6/5/2014 9:33 AM