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Reperfusion With Hypothermia in Acute Ischemic Stroke (RESCUE-HYPO)

Primary Purpose

Ischemic Stroke, Revascularization, Endovascular Treatment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermogard XP3
Sponsored by
Liping Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
    Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
    final infarct volume(FIV)
    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)
    Compare the rate of 90-day mRS (0-2) between study group and control group
    The rate of early neurological deterioration
    increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
    The rate of mortality
    The rate of mortality
    Systematic Intracranial Hemorrhagr(sICH)
    sICH with 24 ±3h post recanalization

    Full Information

    First Posted
    January 3, 2023
    Last Updated
    January 10, 2023
    Sponsor
    Liping Liu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05676957
    Brief Title
    Reperfusion With Hypothermia in Acute Ischemic Stroke
    Acronym
    RESCUE-HYPO
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Liping Liu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury
    Keywords
    Ischemic Stroke, Revascularization, Endovascular Treatment, Reperfusion Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Thermogard XP3
    Other Intervention Name(s)
    intravascular hypothermia treatment
    Intervention Description
    Patients received endovascular hypothermia for 12 hours following endovascular treatment and recanalization.
    Primary Outcome Measure Information:
    Title
    Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
    Description
    Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
    Time Frame
    2 hour after thrombectomy
    Title
    final infarct volume(FIV)
    Description
    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.
    Time Frame
    three to seven days after endovascular therapy
    Secondary Outcome Measure Information:
    Title
    the rate of 90-day modified Rankin Scale (mRS)(0-2)
    Description
    Compare the rate of 90-day mRS (0-2) between study group and control group
    Time Frame
    90 days
    Title
    The rate of early neurological deterioration
    Description
    increasing of National Institute of Health Stroke Scale(NIHSS) ≥ 4 points 24 hours after recanalization
    Time Frame
    24 hours
    Title
    The rate of mortality
    Description
    The rate of mortality
    Time Frame
    90 days
    Title
    Systematic Intracranial Hemorrhagr(sICH)
    Description
    sICH with 24 ±3h post recanalization
    Time Frame
    24 ±3hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Man Li
    Phone
    13141410249
    Email
    lemmon_20@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liping Liu
    Organizational Affiliation
    Beijing Tiantan Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Reperfusion With Hypothermia in Acute Ischemic Stroke

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