Adult patients who experience a cardiac arrest at NYU Langone’s Tisch Hospital will be included in an innovative research study that aims to enhance survival rates and reduce brain damage. While extremely unlikely, this indicates that in the event that you have a cardiac arrest at Tisch Hospital, you will be included in this study. Unless you have an objection to blood transfusions documented in your medical records, the only way to not be included in this study is to explicitly decline participation through an opt-out form in advance.

The purpose of this study is to assess how a blood transfusion may improve the amount of oxygen getting to the heart, brain, and other vital organs during cardiac arrest in the hopes of improving patients’ likelihood of survival. One of the most effective ways of delivering more oxygen to the body is to administer red blood cells. Red blood cells are commonly given to help improve oxygen delivery throughout the body, since red blood cells play a key role in transporting oxygen from the lungs to your muscles and organs, including your brain. The transfusion will be administered in addition to all standard cardiac arrest treatments, including cardiopulmonary resuscitation, or CPR. These conventional treatments have remained largely unchanged for the past six decades. CPR can only revive approximately 1 out of 10 individuals whose hearts stop beating. Therefore, there's an urgent need to develop new treatments to enhance the chances of restarting the heart and prevent brain injury in cardiac arrest cases.

Blood transfusions are U.S. Food and Drug Administration (FDA)–approved routine treatments that are often given to patients with low blood count. This study will be administering blood transfusions to patients who experience a cardiac arrest and receive CPR, which is currently not an FDA-approved procedure. For this reason, the blood transfusion is considered an “experimental drug.”

Why This Study May Be of Interest to You

While the likelihood of experiencing an unforeseen cardiac arrest is low, it remains a possibility for anyone, whether at home or in a healthcare setting. Cardiac arrest is a critical medical emergency where the heart stops beating, ultimately resulting in death unless prompt CPR measures are taken. Despite treatment efforts, the mortality rate remains high, with many enduring varying degrees of brain injury due to lack of oxygen. New methods in cardiac arrest treatments, such as blood transfusions, are imperative to enhance survival rates and reduce organ damage.

Who May Participate in This Study

Adult patients aged 18 years or older who experience a cardiac arrest in Tisch Hospital are eligible for the study.

How This Study Will Take Place

If you are eligible for the study, you will be randomized (randomly assigned, by chance, like flipping a coin) to one of three arms. The arms are the control group and two intervention groups. The first intervention group will receive normal CPR with the addition of a one-unit red blood cell transfusion. The second intervention group will receive normal CPR with the addition of a two-unit red blood cell transfusion. The control group will receive normal CPR with a salt water, or saline, solution.

Throughout this period, you will receive standard cardiac arrest treatment along with a blood transfusion, which may involve targeted temperature management (treatment to achieve and maintain a specific body temperature), ventilator management, and routine blood monitoring. Due to the unforeseen and urgent nature of cardiac arrest, and the unconscious state of patients, transfusions must be administered before obtaining your consent.

We will promptly seek consent from your legal authorized representative (LAR). If your LAR cannot be reached and you are incapable of providing consent, a family member may have the chance to express objections to your inclusion in the study. In the event that no one can provide consent and there are no objections, a waiver of consent has been authorized by both the FDA and NYU Langone’s Institutional Review Board (IRB).

The study will require an assessment at hospital discharge, 30 days, and 90 days after your heart stops in order to assess how well your brain is functioning.

We expect to enroll approximately 30 patients at Tisch Hospital. Your study duration will last only a maximum of 90 days, but the study will conclude enrolling patients in approximately 3 years.

What Are the Risks of Participating in This Study?

Learn about potential risks of blood transfusions and normal saline infusions that may be associated with participation in this study.

Risks of Blood Transfusion

Blood transfusions are very common procedures in hospitals, but they have not been approved to treat in-hospital cardiac arrests by the FDA, so they are considered experimental in this study. Some common, nonserious side effects that people may experience may include the following:

• temporary pain and bruising where the intravenous (IV) needle enters the skin
• swelling or redness where the needle enters the skin
• allergic reactions that may include hives, itching, and fever
• fever

Rare, but serious side effects may include the following:

• infections, such as HIV or hepatitis C
• hemolytic reactions, where the body’s immune system destroys the transfused red blood cells
• serious allergic reactions
• transfusion-related acute lung injury, a serious condition which may make it difficult to breathe
• transfusion-associated circulatory overload, a serious condition that occurs when patients are transfused with a large volume of blood, which can cause swelling, increased blood pressure, or changes in your heart’s ability to pump blood throughout your body
• hyperkalemia, a condition where there is excess potassium in your bloodstream
• death

If you begin to exhibit signs of any rare, but serious side effects, your transfusion will be stopped, and the clinical team will treat your symptoms in accordance to NYU Langone standard operating procedures.

It is important to note that there may be unforeseen risks to having blood transfusions that are not currently known.

Risks of Normal Saline Infusion

Normal saline is a sterile solution of salt in water that is very commonly given to patients in hospitals to replenish the amounts of water in their bodies.

Some common, nonserious side effects may include the following:

• swelling, redness, or pain where the needle enters your skin

Some rare, but serious side effects may include the following:

• increased heart rate
• hypervolemia, a condition where there is too much fluid in the body, which can lead to swelling and shortness of breath

If you begin to exhibit signs of any serious side effects, your infusion will be stopped, and the clinical team will treat your symptoms in accordance to NYU Langone standard treatment protocols.

What Are the Benefits of Participating in This Study?

You may or may not benefit personally from being in this study. However, we hope that future individuals may derive benefits from what we learn, potentially leading to improvements in cardiac arrest care. These improvements could potentially benefit future patients experiencing cardiac arrest.

How Can I Participate in or Opt Out of This Study?

Individuals who suffer a cardiac arrest during their stay at Tisch Hospital and meet the eligibility requirements will be enrolled in this study.

For further information about the study, please reach out to the study team via email at CardiacArrest@NYULangone.org or via phone at 646-899-7325.

How to Opt Out

Participation in this study is entirely voluntary, and anyone may withdraw at any point without facing any repercussions. Declining to participate will not affect the standard medical care provided following a cardiac arrest.

Please complete this opt-out form if you would like to opt out of participating in this study.