Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke (THIS)

March 19, 2023 updated by: LiqunYang, RenJi Hospital

Safety and Efficacy of Therapeutic Hypothermia in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy: a Prospective, Randomized, Controlled Clinical Study

Therapeutic hypothermia (TH) in stroke has demonstrated robust neuroprotection in animals especially after ischemia-reperfusion injury, but its safety and efficacy remain controversial. The investigators propose this trial to study the clinical and radiological effects of therapeutic hypothermia in acute ischemic stroke patients treated with intravascular thrombectomy (IVT).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline will be circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C, which is superior to surface methods in cooling performance in terms of faster rate of cooling, shorter induced cooling time, precise control during maintenance. Thereafter, hypothermia will be maintained for 24 hrs from the start of hypothermia. The patients will be rewarmed slowly at a rate of no greater than 0.5 °C every 4 h. What's more, patients in TH group will execute anti-shivering protocol during awaking and extubation.

Study Type

Interventional

Enrollment (Anticipated)

252

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

Study Locations

  • China
      • Shanghai, China, 200127
        • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18-85 years(inclusive);
  2. Patients have clinical signs consistent with acute ischemic stroke,
  3. Patients with acute large vessel occlusion including internal carotid artery and middle cerebral artery M1 and M2 demonstrated by CTA，MRA or DSA
  4. The possibility to receive arterial thrombus removal treatment （within6 or24 hr of large vessel occlusion ）;
  5. Provide the informed consent form of the patient or the patient's agent.

Exclusion Criteria:

  1. Coma or altered vigilance defined as a score ≥2 on the level of consciousness 1A subscale of the NIHSS.
  2. Associated cerebral hemorrhage.
  3. There is dysfunction before the onset, mRS score >= 2 points;
  4. Accompanied by severe comorbidities (such as severe cardiopulmonary insufficiency, the expected survival period of advanced malignant tumors is less than 90 days);
  5. Multi-mode CT/MRI examination of the corresponding contrast agent use contraindications (such as contrast agent allergy, etc.);
  6. Women during pregnancy or lactation;
  7. Patients currently participating in other clinical research trials;
  8. Other conditions judged by the investigator as not suitable for inclusion in the clinical study.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Normothermia arm
Patients randomized to normothermia will be maintained at 36-37°C during the entire study period.
Experimental: Therapeutic hypothermia arm
Patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C
Procedure: Therapeutic hypothermia
The study intervention is therapeutic hypothermia. After intubation, patients assigned to therapeutic hypothermia will receive central venous catheterization through right jugular vein or femoral vein depending on the cooling application and the unique needs, a flexible catheter will be inserted and iced saline was circulated through the multiple balloons of the catheter in a closed-loop design to induce therapeutic hypothermia. This system also has a hydrophilic coating with heparin and a triple-lumen central venous catheter to satisfy the need of fluid or drug infusion, blood draw and central venous pressure monitoring. After central venous catheterization, patients assigned to TH will receive intravascular temperature management to achieve the target temperature of 34-35 °C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological function prognosis
Time Frame: 90±14 days post-operation
the score on the modified Rankin Scale, seven grades ranked from 0 to 6, higher scores mean worse outcome
90±14 days post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of mRS score 2 or less
Time Frame: 90±14 days post-operation
the ratio of modified Rankin Scale score 2 or less, modified Rankin Scale has seven grades ranked from 0 to 6, higher scores mean worse outcome
90±14 days post-operation
Incidence of intracranial hemorrhage and symptomatic intracranial hemorrhage
Time Frame: 24-72 hours post-operation
Radiological examination（CT or MRI）
24-72 hours post-operation
Target vascular recanalization rate
Time Frame: 24-72 hours post-operation
Cerebral angiography
24-72 hours post-operation
NIHSS score
Time Frame: 7 days post-operation
The score of National Institute of Health stroke scale, NIHSS score ranked from 0 to 42, higher scores mean a worse neurological outcome
7 days post-operation
Final infarct volume
Time Frame: 7 days post-operation
CT scan
7 days post-operation
Death in hospital & within 90 days
Time Frame: Within 90 days after admission
Death in 90 days
Within 90 days after admission
The incidence of adverse event
Time Frame: Within 7 days post-operation
Surgery-related complications: vascular perforation, arterial dissection, and distal embolization；Incidence of pneumonia within 7 days; Incidence of deep vein thrombosis within 7 days
Within 7 days post-operation
Adverse events of hypothermia and rewarming
Time Frame: Within 24 hours post-operation
arrhythmia (atrial fibrillation, ventricular fibrillation), hypokalemia, Chilblains or pressure ulcers; Rewarming shock and hyperkalemia
Within 24 hours post-operation

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Liqun Yang, Ph.D., Renji Hospital, Shanghai Jiao Tong University School of Moedicine

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)

May 1, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

October 31, 2024

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-2022-180

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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