RESCUE-HYPO: Reperfusion With Hypothermia in Acute Ischemic Stroke

Sponsor

Liping Liu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05676957

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine the feasibility and safety of receiving intravascular hypothermia treatment for patients experiencing endovascular treatment after acute ischemic stroke(AIS) due to a large vessel occlusion.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Revascularization Endovascular Treatment Reperfusion Injury	Device: Thermogard XP3	N/A

Detailed Description

Hypothermia has been confirmed and widely applied in the treatment of coma patients after resuscitation from cardiac arrest, but its effect on the prognosis of patients with AIS is still controversial. Previous basic research has confirmed that hypothermia can significantly reduce the infarct volume and improve the survival rate and behavioral defects of mice by protecting ischemic brain tissue and improving reperfusion injury through a variety of ways. Therefore, we hypothesized that hypothermia can improve the prognosis of patients with AIS after reperfusion by improving reperfusion injury. This is a phase II clinical trial to to verify the efficacy and safety of endovascular hypothermia in these patients,This study enrolled patients with massive cerebral infarction after endovascular treatment recanalization, patients are divided into study group and control group. The study group received endovascular hypothermia for 12 hours following endovascular treatment and recanalization, and the control group received only usual medical treatment following endovascular treatment and recanalization. We will preliminarily explore the mechanism of endovascular hypothermia in successful reperfusion of large vessel occlusion AIS, and to provide reference for the design of future clinical trials.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized-controlled Trial to Assess the Safety and Efficacy of Intravascular Hypothermia in Acute Ischemia Stroke Patients With Recanalization After Thrombectomy

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.	Device: Thermogard XP3 Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization. Other Names: intravascular hypothermia treatment
No Intervention: Control group The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.

Arm

Intervention/Treatment

Experimental: Study group

The subjects will be considered to be enrolled in the study group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the study group of the trial to allow endovascular therapy with the Thermogard XP3 Intravascular Temperature Management (IVTM) System after recanalization.

Device: Thermogard XP3

Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization.

Other Names:

intravascular hypothermia treatment

No Intervention: Control group

The subjects will be considered to be enrolled in the control group of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the control group of the trial.

Outcome Measures

Primary Outcome Measures

Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization. [2 hour after thrombectomy]
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
final infarct volume（FIV） [three to seven days after endovascular therapy]
Infarct volume was assessed according to the non-contrast Computed Tomography (NCCT) 3-7 days after surgery, and if several NCCT examinations were performed within 3-7 days, the last CT was used.

Secondary Outcome Measures

the rate of 90-day modified Rankin Scale (mRS)(0-2) [90 days]
Compare the rate of 90-day mRS (0-2) between study group and control group
The rate of early neurological deterioration [24 hours]
increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
The rate of mortality [90 days]
The rate of mortality
Systematic Intracranial Hemorrhagr(sICH) [24 ±3hours]
sICH with 24 ±3h post recanalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 18-80 years;
Patients with symptoms consistent with an AIS;
Pre-stroke mRS score 0-1;
NIHSS score 6-30 at the time of randomization;
Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography(MRA) proved occlusion of Internal Carotid Artery (ICA) terminal or M1 segment of Middle Cerebral Artery;
Imaging showed massive infarction: within 24h of onset and Alberta Stroke Program Early CT Score (ASPECTS) < 3, and large infarct core 70-100 ml (CT perfusion [ Relative Cerebral Blood Flow (rCBF) < 30%]); within 24h of onset and ASPCECTS score 3-5 (based on NCCT); ASPECTS > 5, within 6h-24h of onset,and large infarct core 70-100 ml (CTP [rCBF < 30%]);
Successful recanalization of occluded vessel (modified Thrombolysis in Cerebral Infarction (mTICI) scores 2b/3) after EVT;
Patients and/or their families agreed to enter the trial.

Exclusion Criteria:

CT after reperfusion showed PH2 hemorrhagic transformation;
bilateral stroke or multiple intracranial occlusions;
known presence of Inferior Vena Cava (IVC) filter;
end-stage renal disease on hemodialysis;
known hemorrhagic diathesis, coagulation factor deficiency or platelet count < 5 × 109/L, International Normalized Ratio(INR) > 1.7;
known hypersensitivity to meperidine, buspirone, midazolam and other sedative and analgesic drugs;
pregnant women;
combined malignant tumors, sepsis, hypothyroidism;
unstable vital signs/dying state, requiring vasoactive drugs to maintain hemodynamic stability and in the incremental phase;
cardiac function grade 4/severe liver and kidney dysfunction;
has participated in other drugs or device clinical trials that may have an impact on the current study;
other reasons lead the investigator to believe that patients are not suitable to continue hypothermia treatment.