Decompressive Surgery Plus Hypothermia for Space occupying Stroke (Depth-SOS)

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00000623
• Date of registration: 21/03/2011
• Prospective Registration: Yes
• Primary sponsor: Ostalb-Klinikum Aalen
• Public title: Decompressive Surgery Plus Hypothermia for Space occupying Stroke (Depth-SOS)
• Scientific title: Decompressive Surgery Plus Hypothermia for Space occupying Stroke (Depth-SOS) - DEPTH-SOS DEcompressive Surgery Plus Hypothermia in Space Occupying Stroke
• Date of first enrolment: 10/08/2011
• Target sample size: 50
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00000623
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: other
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Hermann Neugebauer
• Affiliation: Universitäts- und Rehabilitationskliniken Ulm, RKU, Klinik für Neurologie

• Name: Eric Jüttler
• Affiliation: Ostalb-Klinikum Aalen

Key inclusion & exclusion 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: 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)

Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

I63

Cerebral infarction

Intervention(s)

Group 1: decompressive hemicraniectomy
Group 2: decompressive hemicraniectomy plus induced mild hypothermia (32-34°C)

Primary Outcome(s)

The primary endpoint is mortality at discharge (day 14).

Secondary Outcome(s)

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

Secondary ID(s)

U1111-1119-9481

Source(s) of Monetary Support

Centrum für Schlaganfallforschung Berlin (CSB) Charite - Universitätsmedizin Berlin Campus Virchow-Klinikum

Ethics review

Status: Approved
Approval date: 24/02/2011
Contact:

[e-mail]

Ethik-Kommission der Medizinischen Fakultät der Universität Erlangen-Nürnberg

[phone]

[e-mail]

Results

• Date Completed: 08/09/2016
• URL: http://drks.de/search/en/trial/DRKS00000623#studyResults