Acute ischemic stroke (AIS) has been one of the major causes of global mortality and morbidity. The superiority of endovascular therapy (EVT) over standard medical therapy in treating AIS due to large vessel occlusion (LVO) in the anterior circulation has been widely accepted. However, a critical concern is that even with an extremely high rate of successful recanalization (the modified thrombolysis in cerebral infarction \[mTICI\] score 2b-3) around 90%, nearly half of the patients failed to benefit from EVT. So, adjunctive therapy of EVT for neuroprotection is required. From the previous domestic and foreign literatures, hypothermia can prevent and treat secondary injury caused by ischemia-reperfusion injury and cerebral edema of acute cerebral ischemia, so as to achieve the role of neuroprotection. In this study, intravascular cooling was performed as soon as possible with careful temperature control in patients receiving thrombectomy. The temperature was controlled at 33° C for 48-72 hours. This parallel controlled study is to systematically evaluate the feasibility and safety of adjunctive therapy using early intravascular hypothermia in AIS patients receiving mechanical thrombectomy. The results will clarify a potential modality for neuroprotection and hopefully provide new evidence in improving patient prognosis.
In this study, the target subjects were AIS patients with successful recanalization (mTICI 2b-3). Early intravascular hypothermia neuroprotection therapy was given to patients after thrombectomy to evaluate its safety and effectiveness. The neuroprotection effect of endovascular hypothermia therapy is explored regarding several aspects, such as hemorrhagic conversion rate, cerebral edema, and neurological function recovery, with specific evaluation criteria described in detail in the following experimental design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
ZOLL Intravascular Temperature Management system, Quattro catheter
Standard Treatment for Ischemic Strokre
Xuanwu Hospital
Beijing, China
RECRUITINGIntracranial hemorrhage conversion rate
ICH
Time frame: 7 days after thrombectomy operation or discharge
Modified Rankin scale (mRS)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Time frame: 90 days
The rate of functional independency (mRS 0-2)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Time frame: 90 days
The rate of mortality (mRS 6)
The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death)
Time frame: 90 days
NIHSS
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
Time frame: 24 hours, 7 days or discharge
Rate of symptomatic intracranial hemorrhage (sICH)
The diagnosis of sICH was based on the association of ICH with any of the following. conditions: (1) Increase in NIHSS score \> 4 points compared to the score before ICH; (2) Increase in NIHSS score by \>2 points in one category; (3) deterioration leading to intubation, hemicraniectomy, external ventricular drain placement, or any other major interventions.
Time frame: 7 days after thrombectomy operation or discharge
Rate of malignant cerebral edema
Development of signs of herniation (including decrease in consciousness and/or anisocoria), accompanied by midline shift \>= 5 mm on follow-up imaging.
Time frame: 7 days after thrombectomy operation or discharge
Infarct volume
measured on 5-7 days CT (or MRI if available)
Time frame: 5-7 days after thrombectomy operation or discharge
Xin Qu,MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.