I63
Conditions
Interventions
Group 1: decompressive hemicraniectomy
Group 2: decompressive hemicraniectomy plus induced mild hypothermia (32-34°C)
Sponsors
Ostalb-Klinikum Aalen
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Clinical signs of infarction in the territory of the MCA 2. Score on the National Institutes of Health stroke scale (NIHSS) >14 (in non-dominant hemispheric infarctions) or >19 (in dominant hemispheric infarctions). * 3. Score in the level of consciousness (item 1a of the NIHSS) of 1 or more. * 4. Definite infarction on CT or MRI of at least 2/3 of the MCA territory, with involvement of the basal ganglia, with or without additional infarction of the territory of the anterior or posterior cerebral artery on the same side, or infarct volume >145 cm3 as shown on diffusion-weighted MRI. Imaging related inclusion and exclusion criteria may be obtained at initial presentation or at follow-up imaging before randomization and within 48h from symptom onset to operation. 5. Decision for hemicraniectomie has been made by the treating physician(s). 6. Hemicraniectomy within 48h after symptom onset. 7. Induced Hypothermia within 12h after hemicraniectomy 8. Informed consent by either the patient, the legal representative, a judge, or by an independet physician. 9. *Inclusion criteria 2 and 3 do not apply for in intubated, ventilated, sedated and/or relaxated patients and are therefore not considered in these patients.
Exclusion criteria
Exclusion criteria: 1. age =61 years. 2. prestroke mRS =2 or Barthel-index < 95. 3. concomittant additional brain damage in (e.g. traumatic brain injury, contralateral ischaemia) that could confound the treatmnt effect on outcome. 4. bilateral fixed dilated pupils. 5. GCS <6. 6. space-occupying haemorrhagic. transformation of the infarct (=parenchymal haemorrhage grade 2). 7. known coagulopathy or systemic bleeding disorder. 8. life expectancy <3 years. 9. contraindication for hypothermia. 10. known contraindication haematological diseases (kryoglobulinemia, cold agglutination, sikcle cell anemia). 11. known vasopastic vascular disease (M. Raynaud, endangiitis obliterans). 12. pregnancy. 13. advanced malignancy with poor prognosis. 14. severe inflammatory response syndrome or sepsis. 15. local conditions which make catheters placement impossible (maceration or severe infection of the skin, arterial aneurysm on both femoral arteries). 16. Known indication for hypothermia (e.g. cardiopulmonal resuscitation) 17. Participation in other interventional trial (participation in observational trials is possible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is mortality at discharge (day 14). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time from symptom onset to death or time from symptom onset to discharge 2. Disability according to the modified Rankin Scale after 6 months 3. Disability (Barthel index) after 6 months 4. Neurological status (NIHSS) after 6 months 5. Complications related to surgery 6. Complications realted to hypothermia 7. Rate of pneumonia 8. Sepsis 9. Use of katecholamines 10. Duration of ventilation 11. Duration of hypothermia 12. Time to target temperature 13. Rate of major bleedings 14. Rate of deep venous thromboses 15. Rate of pulmonary embolism | — |
Countries
Germany
Contacts
Public ContactHermann Neugebauer
Universitäts- und Rehabilitationskliniken Ulm, RKU, Klinik für Neurologie
Outcome results
None listed