Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06301412

Combination of Hypothermia and Thrombectomy in Acute Stroke

Led by University of Freiburg · Updated on 2025-01-06

400

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

U

University of Freiburg

Lead Sponsor

E

European Union

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combination of Hypothermia and Thrombectomy in Acute Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pre-stroke modified Rankin Scale (mRS) 0-2
  • Acute ischemic stroke with NIHSS greater than 5
  • Intracranial occlusion of the M1 or M2 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) or tandem occlusion confirmed by CT-angiography or MR-angiography
  • Time window 0-24 hours from last seen normal to groin puncture:
    • If less than 6 hours: native CT or MRI-DWI with ASPECTS greater than 5
    • If 6-24 hours or unknown time window: significant mismatch on imaging per DEFUSE-3 criteria
      • Infarct core less than 70 ml
      • Penumbra greater than 15 ml
      • Ratio of penumbra to core greater than 1.8
  • With or without intravenous thrombolysis with rtPA
Not Eligible

You will not qualify if you...

  • Intranasal obstruction preventing complete insertion of nasal cannula for RhinoChill system
  • Known severe hemorrhagic diathesis (INR greater than 3.0, PTT greater than 70 seconds, platelet count less than 50,000/µl)
  • Brain trauma or neurovascular surgery/intervention within last 3 months
  • Severe infection
  • Pregnant women or women of childbearing potential (except those with negative pregnancy test)
  • Known cerebral vasculitis
  • Evidence of bleeding on cerebral CT or MRI (except cerebral microbleeds related to hypertension or amyloid angiopathy)
  • Known life expectancy less than 6 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Freiburg, Department of Neurology

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

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Research Team

J

Juergen Bardutzky, Prof.

CONTACT

W

Wolf-Dirk Niesen, PD Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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