Combination of Hypothermia and Thrombectomy in Acute Stroke

Sponsor
University of Freiburg
Study ID
NCT06301412
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hypothermia — DEVICE
    hypothermia is started after intubation for endovascular treatment and induced by transnasal cooling (RhinoChill) to a target temperature of 35°C and hypothermia is then maintained at 35°C for 6 hours after recanalisation by surface cooling followed by slow rewarming by 0.2°C per hour to 36.5°C

Study Details

The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.

Key Dates

Start date
Jul 7, 2024
Status verified
Jan 2025
Primary completion
Mar 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: EVT group
    standard endovascular treatment (EVT) for large vessel occlusion (LVO) without hypothermia
  • Active Comparator: EVT group plus hypothermia group
    standard endovascular treatment (EVT) for large vessel occlusion (LVO) combined with hypothermia

Primary Outcome Measure

functional outcome [ Time Frame: 3 months ]

Central Contacts

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