Clinical trial NCT01665885: Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE)
Official title: HAIS-SE (Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling): A Randomized Trial Comparing Surface Versus Endovascular Cooling in Awake Stroke Patients Treated With Thrombolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Stroke
Thrombolysis
Hypothermia
Keywords: hypothermia
induction of hypothermia
non invasive cooling
external cooling
surface cooling
endovascular cooling
cooling catheter
stroke
shivering
neuro monitoring
coagulation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: ZOLL Circulation, Inc., USA
First posted: 2012-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Detailed description: Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Via animal models hypothermia has been identified as the most promising neuroprotective therapy in focal cerebral ischemia as well. But the prove of clinical benefit in patients with acute ischemic stroke is still missing: Most likely due to the prolonged time window until hypothermia-induction (14 h) in previous studies. In addition, feasibility of the method through which hypothermia is applied is crucial for a broad implementation of hypothermia in stroke therapy. Surface versus endovascular cooling have never been compared in a prospective trial in awake stroke patients.

HAIS-SE is evaluating for the first time ever in a randomized controlled trial efficacy, tolerability, practicability and safety of endovascular versus surface cooling in awake stroke patients.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke
* Intravenous thrombolysis within 4.5h from symptom onset
* Informed consent of the patient
* NIHSS score ≥ 2 and ≤ 20
* Age ≥ 18 and ≤ 90 years
* Placement of cooling catheter / cooling pads within 6h from symptom onset

Exclusion Criteria:

* (Expected) intubation (e.g. for interventional treatment)
* Pregnancy
* Body weight \> 120kg
* Body height \< 150cm
* Life-expectancy \< 3 months
* Fever \> 38.5°C at screening
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Possible compression of the inferior vena cava (e.g. due to tumor) or vena cava filter
* Acute pulmonary embolism
* Acute myocardial infarction
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* QTc-interval \> 450ms
* Bradycardia \< 50/min
* Sick-Sinus-Syndrom
* AV-block \> I°
* Severe infection with bacteremia or sepsis ≤ 72h
* Severe renal (GFR \< 30ml/min) or liver insufficiency (Child-Pugh C)
* Myopathy
* Known intolerance or allergy against acetaminophen, buspirone, clonidine, magnesium sulphate or pethidine.
* Treatment with MAO-inhibitors ≤ 14 days
* Acute closed-angle glaucoma

Primary outcomes:
measure: Body core temperature
timeFrame: 0 to 48h
Secondary outcomes:
measure: Efficacy
timeFrame: 0 to 48h
measure: Tolerability
timeFrame: 0 to 48h
measure: Practicability
timeFrame: 0 to 48h
measure: Safety
timeFrame: 0 to d90
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Stroke Unit, Dept. of Neurology, University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Sven Poli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: