Your session is about to expire
← Back to Search
Temperature Modulation
Induced Hypothermia for Stroke
Phase 2
Waitlist Available
Led By Fred Rincon, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Spontaneous supratentorial IPH documented by CT scan within 6 hours after the onset of symptoms and admission to the Neuro-ICU
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous throughout 3 year study period
Awards & highlights
Study Summary
This trial is testing whether induced hypothermia after spontaneous brain bleed is safe and effective in reducing hematoma growth and cerebral edema.
Who is the study for?
This trial is for adults with a spontaneous brain bleed (over 15cc) who arrived at the hospital within 6 hours of symptom onset and need mechanical breathing support. It's not for those under 18, pregnant, with certain pre-existing conditions, planning surgery within a day, or unable to consent.Check my eligibility
What is being tested?
The study tests if cooling the body to mild hypothermia (32-34°C) right after a brain hemorrhage can reduce swelling and bleeding in the brain by calming inflammation compared to keeping normal body temperature.See study design
What are the potential side effects?
Mild induced hypothermia may cause shivering, increased heart rate and blood pressure changes, risk of infection due to immune system effects, electrolyte imbalances, and potential clotting issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a brain bleed confirmed by a CT scan within 6 hours of symptom onset and was admitted to the Neuro-ICU.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuous throughout 3 year study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous throughout 3 year study period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of adverse events (AEs) that will be possibly or probably related to the treatment.
Secondary outcome measures
In-hospital neurological deterioration between day 0-7.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Normal TemperatureExperimental Treatment1 Intervention
72 hours of Normal Temperature (36-37 degrees Celcius). Subjects in all arms will otherwise receive identical therapeutic interventions pre-defined by our local IPH management protocol.
Group II: Mild Induced HypothermiaExperimental Treatment1 Intervention
72 hours of mild induced hypothermia (32-34 degrees Celcius). Subjects in all arms will otherwise receive identical therapeutic interventions pre-defined by our local IPH management protocol.
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,524 Total Patients Enrolled
1 Trials studying Hypothermia
28 Patients Enrolled for Hypothermia
Fred Rincon, MDPrincipal InvestigatorThomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to relieve pressure within 24 hours.I do not have any other health issues that could cause bleeding in my brain.I had a brain bleed confirmed by a CT scan within 6 hours of symptom onset and was admitted to the Neuro-ICU.My consciousness level is very low.You have a large amount of bleeding in your brain before the study starts.I am under 18 years old.I do not have ongoing uncontrolled bleeding issues.You require a machine to help you breathe.You have a pre-existing condition that affects your ability to perform daily activities.You have signs of a severe infection called sepsis.
Research Study Groups:
This trial has the following groups:- Group 1: Normal Temperature
- Group 2: Mild Induced Hypothermia
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.
Are there any current opportunities to participate in this study?
"This particular medical trial is not currently open for sign-ups, as the information provided on clinicaltrials.gov reveals; initially posted in September 2012 with its last update occurring in December 2014. Despite that, 403 other trials are presently looking to include participants."
Answered by AI
Has the FDA sanctioned mild induced hypothermia as a therapeutic treatment?
"The safety rating of mild induced hypothermia was assigned a 2, reflecting the fact that only preliminary evidence exists in regards to its efficacy. That said, there is sufficient data which confirms the procedure's safety for Phase 2 clinical trials."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger