Combination of Hypothermia and Thrombectomy in Acute Stroke

ConditionsIschemic Stroke Large Vessel Occlusion Endovascular Treatment

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Freiburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre-stroke modified Rankin Scale (mRS) 0-2 [7-point scale rating from 0 (no symptoms) to 6 (dead)]

Acute ischemic stroke with NIHSS >5

Last seen normal to groin puncture < 6h: native CT or MRI-DWI with ASPECTS >5

Last seen normal to groin puncture 6-24h or unknown time window: significant mismatch imaging according to the eligibility criteria of the DEFUSE-3 trial

Disqualifiers

Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system.

Known severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/μl)

Brain trauma or neurovascular surgery/intervention <3 months

Severe infection

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: EVT groupNo intervention 0 interventions

Group B: EVT group plus hypothermia groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

functional outcome

The presence of patients with good neurological outcome after 3 months as defined by modified Rankin Scale (mRS; on which scores range from 0 to 6, with 0 means no symptoms and 6 means death) of 0-2 or back to baseline before stroke

Time frame

3 months

Secondary outcomes

infarction volume

Infarction volume assessed in the standard CT 24 hours after thrombectomy

Time frame

24 hours

increase in infarction

increase of the infarct core based on imaging at the time of admission (DWI-MRI or CBF\<30% of contralateral side at CT-Perfusion) and CT after 24 hours

Time frame

24 hours

recanalization result

Recanalization result (by mTICI score: successful recanalization mTICI 2b-3) after thrombectomy (based on angiography during/after thrombectomy) and 24 hours after thrombectomy (based on ultrasound of the cerebral vessels)

Time frame

after thrombectomy and 24 hours

neurological improvement

Change of at least 8 points on the National Institutes of Health Stroke Scale (NIHSS; on which scores range from 0 to 42, with higher scores indicating a greater deficit) at 48 hours after thrombectomy

Time frame

48 hours

Other outcomes

Occurrence of intracerebral haemorrhage (ICH)

* Any ICH (subarachnoid, intraparenchymal, intraventricular) on the CT after 24 hours * Symptomatic ICH (defined according to SITS-MOST criteria): Hematoma \>30% of initial infarction volume associated with a clinical deterioration in NIHSS score of at least 4 points within 24 hours after thrombectomy

Time frame

24 hours

Complications associated with hypothermia

* Nosebleed and pailing of the nose * Periorbital emphysema * Pneumocephalus (in 24-hour control CT) * Blood pressure, heart rate, oxygen saturation SO2 * Episodes with severe hypotension with systolic blood pressure \<110mmHg * Incidence of pneumonia (defined as: any new pulmonary infiltrate on radiographic imaging occurring \<48hrs after admission combined with at least one of the subsequent findings: fever \>38°C, leukopenia/leucocytosis, purulent secretions with positive cultures) * Disturbances in electrolytes, renal function, coagulation (potassium, sodium, chloride, creatinine, INR, pTT, thrombocytes measured on admission before hypothermia and at 24 hours)

Time frame

24hours