Hypothermia in Acute Ischemic Stroke - Surface Versus Endovascular Cooling (HAIS-SE) "HAIS-SE"

Active, not recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • ZOLL Thermogard XP Device
    Other Names: ZOLL Thermogard XP cooling device, ZOLL Circulation, Inc., USA; ZOLL Quattro cooling catheter, ZOLL Circulation, Inc., USA
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Endovascular cooling
    Description: Endovascular cooling using the cooling device ZOLL Thermogard XP with ZOLL Quattro cooling catheter
  • BARD/Medivance Arctic Sun 5000 Device
    Other Names: BARD/Medivance Arctic Sun 5000, C. R. Bard, Inc., USA; BARD/Medivance Arctic Gel Pads, C. R. Bard, Inc., USA
    Intervention Desc: Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
    ARM 1: Kind: Experimental
    Label: Surface cooling
    Description: Surface cooling using the cooling device BARD/Medivance Arctic Sun 5000 with BARD/Medivance Arctic Gel Pads

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Body core temperature 0 to 48h No
Secondary Efficacy 0 to 48h Yes
Secondary Tolerability 0 to 48h No
Secondary Practicability 0 to 48h No
Secondary Safety 0 to d90 Yes

Sponsors