What side effects are associated with this type of intervention?

Common treatments for ischemic stroke that involve rapid hypothermia, such as the Proteus Intravascular Temperature Management (IVTM) system, aim to reduce metabolic demand and limit brain injury. Known side effects of induced hypothermia include shivering, which can increase metabolic demand and counteract the benefits of cooling, as well as potential complications like infection, electrolyte imbalances, and cardiac arrhythmias. Additionally, patients may experience discomfort from the cold and require sedation to tolerate the procedure.

What prior FDA approvals exist?

The FDA has approved several treatments for ischemic stroke, primarily focusing on thrombolysis and mechanical thrombectomy. Tissue plasminogen activator (tPA) is a well-known FDA-approved thrombolytic agent used to dissolve clots and restore blood flow. Mechanical thrombectomy devices, such as stent retrievers, are also FDA-approved for removing clots in large vessel occlusions. While hypothermia is a promising area of research for reducing metabolic demand and limiting brain injury, specific FDA approvals for hypothermia-based treatments in ischemic stroke are not well-documented. Current research, including the Proteus Intravascular Temperature Management (IVTM) system, aims to establish the feasibility and safety of rapid hypothermia in this context.

What other types of research exist?

Promising novel alternatives to the Proteus Intravascular Temperature Management (IVTM) system for ischemic stroke patients include: 1) Surface cooling devices that offer non-invasive hypothermia induction, 2) Endovascular cooling catheters that provide precise temperature control, 3) Neuroprotective agents such as NA-1 (nerinetide) which have shown potential in reducing brain injury, and 4) Advanced thrombolytic therapies that improve reperfusion outcomes. These alternatives are being explored for their efficacy and safety in clinical settings.

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Therapeutic Hypothermia Device

Therapeutic Hypothermia for Stroke (RECCLAIM-II Trial)

N/A

Waitlist Available

Led By Rishi Gupta, MD, MBA

Research Sponsored by ZOLL Circulation, Inc., USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A pre-stroke modified Rankin Score (mRS) of 0 or 1

Age ≥18 and ≤85

Must not have

End stage renal disease on hemodialysis

Patient has active or symptomatic COVID-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 hours

Awards & highlights

Summary

This trial is testing a device called the Proteus IVTM system that cools the body from the inside for patients having severe strokes caused by major blood vessel blockages. The cooling helps protect the brain by slowing its metabolism and reducing damage. Therapeutic hypothermia has been studied for its potential to improve neurological outcomes in stroke patients, with some trials showing feasibility and safety.

Who is the study for?

This trial is for adults aged 18-85 with symptoms of an acute ischemic stroke from a blocked artery in the brain, confirmed by CT scan. They must be able to undergo treatment within 24 hours and have had good health before the stroke. People can't join if they have bleeding disorders, severe kidney disease, are pregnant, or have conditions that could interfere with the study.

What is being tested?

The trial tests if cooling the body quickly using Proteus IVTM system is safe and doable for patients with acute strokes due to large vessel blockage. It compares standard recanalization (unblocking) therapy alone versus unblocking plus rapid hypothermia induced by Thermogard XP3.

What are the potential side effects?

Potential side effects may include reactions related to general anesthesia or sedation used during procedures, issues from cooling such as shivering or cold-related discomforts, and typical risks associated with arterial puncture like bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my stroke.

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I am between 18 and 85 years old.

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I have no allergies or health issues that prevent me from undergoing anesthesia or the planned treatments.

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I have had a stroke caused by a blockage in a large artery in the front part of my brain.

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My brain scan score is suitable for my age group.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on dialysis for end-stage kidney disease.

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I currently have symptoms of COVID-19.

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My neck blood vessels are abnormally twisted.

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I have a blood clot in my lung or leg veins.

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I am shorter than 4 feet 11 inches.

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I am taking warfarin and my INR is above 1.7.

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My blood pressure is very high and not controlled by medication.

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I have severe dementia and am on medication for cognitive or behavioral issues.

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I am showing signs of a severe infection (sepsis).

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I have a history of bleeding disorders or conditions affecting my blood's ability to clot.

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I have a stent in my brain that could affect blood flow restoration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour after thrombectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour after thrombectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after thrombectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean door-to-Recanalization time

Thermography

Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cooling + RecanalizationExperimental Treatment1 Intervention

The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after recanalization.

Group II: Recanalization onlyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thermogard XP3

2019

N/A

~90

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Proteus Intravascular Temperature Management (IVTM) system aims to achieve rapid hypothermia in patients experiencing acute ischemic stroke. The primary mechanism of action for hypothermia in this context is to reduce the metabolic demand of brain tissue, thereby limiting the extent of brain injury during the critical period following a stroke. By cooling the brain, the treatment slows down cellular metabolism, reduces the production of harmful free radicals, and minimizes the inflammatory response, which collectively help to preserve brain function and improve outcomes. This approach is particularly important for ischemic stroke patients as it can potentially reduce the extent of irreversible brain damage and improve recovery prospects.

Temporal limits of therapeutic hypothermia onset in clinical trials for acute ischemic stroke: How early is early enough?