Hypothermia, Ischemic Stroke, Thrombolysis
Conditions
Keywords
hypothermia, induction of hypothermia, non invasive cooling, external cooling, surface cooling, endovascular cooling, cooling catheter, stroke, shivering, neuro monitoring, coagulation
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.
Interventions
DEVICEZOLL Thermogard XP
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis.
DEVICEBARD/Medivance Arctic Sun 5000
Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
Sponsors
ZOLL Circulation, Inc., USA
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body core temperature | 0 to 48h | Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 0 to 48h | Secondary efficacy outcome measures include the amount of patients reaching the primary target body core temperature (34°C), the time-frame until reaching 35°C body core temperature, temperature stability during maintenance and rewarming. |
| Tolerability | 0 to 48h | Tolerability outcome measures include a specific Hypothermia Participant Experience Questionnaire (HPEQ) and the Bedside Shivering Assessment Scale (BSAS) plus correlation with skin temperature, EMG and sNIRS. |
| Practicability | 0 to 48h | Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ). |
| Safety | 0 to d90 | Safety outcome measures include the analysis of (severe) adverse events (e.g. bleeding complications, pneumonia). 0 to 48h: Dose needed of anti-shivering medication, level of sedation (RASS, GCS and BIS), safety laboratory including specific coagulation parameters and monitoring of cerebral auto-regulation including cNIRS and BIS. |
Countries
Germany
Outcome results
None listed