Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 hours
Awards & highlights
RECCLAIM-II Trial Summary
This trial will study whether it is safe and feasible to use a Proteus Intravascular Temperature Management system to rapidly cool patients experiencing acute ischemic stroke due to a large vessel occlusion.
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.Check my eligibility
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.See study design
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.
RECCLAIM-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was independent in daily activities before my stroke.
Select...
I am between 18 and 85 years old.
Select...
I have no allergies or health issues that prevent me from undergoing anesthesia or the planned treatments.
Select...
I have had a stroke caused by a blockage in a large artery in the front part of my brain.
Select...
My brain scan score is suitable for my age group.
RECCLAIM-II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour after thrombectomy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after thrombectomy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean door-to-Recanalization time
Thermography
Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization
RECCLAIM-II 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.
Find a Location
Who is running the clinical trial?
ZOLL Circulation, Inc., USALead Sponsor
12 Previous Clinical Trials
1,239 Total Patients Enrolled
1 Trials studying Ischemic Stroke
60 Patients Enrolled for Ischemic Stroke
Rishi Gupta, MD, MBAPrincipal InvestigatorWellstar Medical Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a stroke severity score of 8 or higher.I am on dialysis for end-stage kidney disease.I currently have symptoms of COVID-19.My neck blood vessels are abnormally twisted.You have reasons that make it unsafe for you to have certain types of medical imaging.I have a blood clot in my lung or leg veins.My legal representative can consent for me, and I can too if I'm able.I was independent in daily activities before my stroke.You don't have any bleeding shown in your initial CT scan.I am eligible for a clot removal procedure in my blood vessels according to stroke guidelines.You have a severe allergy to contrast dye or any condition that makes using contrast dye unsafe.I am shorter than 4 feet 11 inches.I can undergo an arterial puncture within 24 hours of symptom onset.You are allergic to meperidine, buspar, or dexmedetomidine.I am between 18 and 85 years old.You have a filter in the large vein in your abdomen.You have evidence of a recent stroke in more than one area of your brain on a CT or MRI scan.I am taking warfarin and my INR is above 1.7.I can follow the study's procedures and agree to attend all required visits.I am a woman who could be pregnant.Your initial CT or MRI scan shows signs of artery inflammation or damage.My blood pressure is very high and not controlled by medication.I have severe dementia and am on medication for cognitive or behavioral issues.I have heart rhythm problems that my doctor says make certain treatments unsafe for me.I am showing signs of a severe infection (sepsis).I have no allergies or health issues that prevent me from undergoing anesthesia or the planned treatments.I have had a stroke caused by a blockage in a large artery in the front part of my brain.I have a history of bleeding disorders or conditions affecting my blood's ability to clot.Your blood potassium level is less than 2.7.I have a stent in my brain that could affect blood flow restoration.My brain scan score is suitable for my age group.
Research Study Groups:
This trial has the following groups:- Group 1: Cooling + Recanalization
- Group 2: Recanalization only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide information about the current enrollment status of this clinical trial?
"The most recent information available on clinicaltrials.gov suggests that this trial is still recruiting patients. The listing was created on 5/23/2019 and last updated on 6/28/2022."
Answered by AI
Is this clinical trial happening in more than one country?
"Currently, this study is looking for participants at 10 different hospitals. These include Honor Health in Scottsdale, Arizona, University of Chicago Medical Center in Chicago, Illinois, and The Queen's Medical Center in Honolulu, Hawaii among others."
Answered by AI
Who would be an eligible candidate for this clinical trial?
"This clinical trial is open to people aged 18-85 who have had a wake-up stroke. In order to qualify, participants must also meet the following additional criteria: show signs and symptoms of an acute ischemic stroke in the anterior circulation as determined by CT imaging; be able to undergo arterial puncture within 24 hours from symptom onset or last known normal time; have an ASPECTS score of 6-10 on non-contrast CT of the brain if under 80 years old or ASPECTS 9-10 if age 80-85; be a candidate for endovascular thrombectomy therapy according to AHA"
Answered by AI
Would people outside of the target age range be able to qualify for this research opportunity?
"According to the published inclusion criteria, adults aged 18 to 85 are eligible for this trial. There are 74 similar studies for minors and 1304 trials involving seniors."
Answered by AI
How many people fit the qualifications for this research project?
"The sponsor, ZOLL Circulation, Inc., needs to recruit 120 eligible patients from various clinical trial sites in order to commence the study. Some of these locations include Honor Health in Scottsdale, Arizona and University of Chicago Medical Center."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger