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

January 10, 2023 updated by: Liping Liu

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
Time Frame: 2 hour after thrombectomy
Percentage of study group patients achieving target temperature < 34 ºC within 2 hour after recanalization.
2 hour after thrombectomy
final infarct volume（FIV）
Time Frame: 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.
three to seven days after endovascular therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liping Liu

Investigators

  • Principal Investigator: Liping Liu, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE-HYPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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