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| Name | Class |
|---|---|
| ZOLL Circulation, Inc., USA | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular cooling | Active Comparator | Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter |
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| Surface cooling | Active Comparator | Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads |
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| Control group | No Intervention | Best medical treatment following international stroke guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOLL Thermogard XP | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body core temperature | Primary endpoint: Time to primary target body core temperature (34°C) after hypothermia-induction. | 0 to 48h |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 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. | 0 to 48h |
| Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Poli, Dr. med. | University Hospital Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stroke Unit, Dept. of Neurology, University Hospital Heidelberg | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D007035 | Hypothermia |
| D020521 | Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| BARD/Medivance Arctic Sun 5000 | Device | Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling. |
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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. |
| 0 to 48h |
| Practicability | Practicability outcome measures include a specific Hypothermia Nursing Staff Experience Questionnaire (HNEQ). | 0 to 48h |
| Safety | 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. | 0 to d90 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |