Trial Number

155-21

Age range

18 years to 70 years

Gender

Male or Female

Enrolling Patients

Yes

The ARISE study will investigate a new experimental treatment for in-hospital cardiac arrest that may help more patients survive.

Cardiac arrest is the sudden loss of heart function. The current standard treatment of cardiac arrest is chest compressions (also known as CPR), defibrillation, and medicine. Even with these standard treatments, around 75% of patients die due to their cardiac arrest inside the hospital.

If a cardiac arrest patient does not respond to standard treatment the device used in this study – the Neurescue device – is placed. This device may help restart a patient’s heart and protect their brain during a cardiac arrest. The device is used while the patient will continue to receive standard treatment for the cardiac arrest and only once all other options have been attempted without success.

The device consists of a thin tube with a balloon at the tip, and a small computer attached to the tube. The procedure is done by placing the tube through a blood vessel in the leg, and from there into the largest artery of the body and positioned just below the patient’s heart. The balloon is then inflated to direct blood flow toward the heart and the brain by temporarily blocking blood flow to the lower body. The tube with the balloon is removed after the heart is restarted. The device in this study has been cleared for commercial use by the Food and Drug Administration (FDA) for patients requiring emergency control of hemorrhage but not for commercial use for cardiac arrest.

  • Because most patients with a life-threatening cardiac arrest are not able to give consent, this study has been approved by the FDA and the Institutional Review Board (IRB) to enroll patients without their consent.
  • Ten patients will be enrolled from March 2022 to September 2023.
  • Around 75% of patients do not survive their cardiac arrest inside the hospital today.
  • There are significant risks to the study including: kidney complications, paralysis, a blood clot or blockage in blood vessels, death, and neurological impairment.

The procedure of inserting a balloon into the largest artery of the body is a well-known procedure that has been used since 1954 and has been given primarily for the treatment of heavy bleedings, for example after an accident or during surgery on the body’s biggest blood vessels. The procedure has shown to be safe in cardiac arrest caused by bleedings, but more studies are needed to investigate it during non-trauma-related cardiac arrest.

Public Disclosure
Your opinion about this study is very important to us and therefore we kindly ask you to complete our survey at arisestudy.com. Your responses will remain anonymous. For more information about the ARISE study, please email contact@arisestudy.com.

To opt-out of this study, please email “opt-out” with your name and mailing address to contact@arisestudy.com. You will receive an opt-out wrist bracelet to show that you do not wish to participate in this study.

Principal Investigator

MemorialCare Research Center Contact Form

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