Red Blood Cell Transfusion for Cardiac Arrest

Overseen By Natalia Leontovich

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Disqualifiers: DNR/DNI orders, Trauma, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate during cardiac arrest

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether administering packed red blood cells (PRBC) during cardiac arrest can enhance oxygen delivery to the brain and other vital organs. Researchers aim to determine if this approach improves recovery from prolonged cardiac arrests, with a focus on brain health and survival rates. Participants will receive either one or two units of PRBC or a saline solution for comparison. This trial may suit individuals who experience a prolonged, non-trauma-related cardiac arrest in a hospital setting and require CPR for at least 10 minutes. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that packed red blood cells (PRBCs) are generally safe and often used in medical settings, such as surgeries. They help increase blood volume and improve oxygen delivery throughout the body. Studies have found that administering PRBCs early can improve survival rates in patients with significant blood loss. However, some risks exist; for instance, PRBC transfusions during surgery have been linked to a higher chance of complications afterward.

This trial is in an early stage, focusing on the safety of using PRBCs during cardiac arrest (when the heart stops). Since hospitals already widely use PRBCs, they are likely safe, but this study will help confirm that for this specific situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cardiac arrest?

Researchers are excited about using packed red blood cells for cardiac arrest because they offer a potentially game-changing approach compared to traditional treatments like CPR and defibrillation, which mainly focus on restoring heart rhythm. Packed red blood cells can quickly increase oxygen delivery to tissues, which is crucial during a cardiac arrest when blood flow is severely compromised. By providing an immediate boost of oxygen, these transfusions could improve survival rates and outcomes for patients, offering a new tool in emergency cardiac care.

What evidence suggests that packed red blood cell transfusion might be an effective treatment for cardiac arrest?

Research shows that early administration of packed red blood cells (PRBC) can improve survival in cases of severe blood loss. Although direct proof for using PRBC during cardiac arrest is lacking, the hypothesis is that it might enhance oxygen delivery to vital organs during CPR (cardiopulmonary resuscitation). This trial will compare different approaches: one group will receive 1 unit of PRBC, another will receive 2 units, and a third group will receive a saline solution as a placebo comparator. The aim is to determine if PRBC transfusion could lead to better outcomes, such as higher survival rates and improved brain function after cardiac arrest. However, some studies have suggested that PRBC transfusions during surgery can increase risks, so the benefits specifically for cardiac arrest remain under investigation. ^{3 6 7 8 9}

Who Is on the Research Team?

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals experiencing cardiac arrest. It aims to see if giving packed red blood cells (PRBC) during resuscitation can help deliver more oxygen to the brain and other organs.

Inclusion Criteria

I had a heart stoppage in the hospital needing CPR for 10+ minutes.

Exclusion Criteria

I am under 18 years old.

I am over 85 years old.

Patients with DNR/DNI orders (Do Not Resuscitate/Do Not Intubate)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive packed red blood cell transfusion or placebo during cardiac arrest

Immediate during cardiac arrest

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurological outcomes and survival

Up to 90 days post-Cardiac Arrest

What Are the Treatments Tested in This Trial?

Interventions

• Packed Red Blood Cells

Trial Overview The study tests whether 1 or 2 units of PRBCs, compared with saline, improve outcomes like brain oxygen levels, chances of restarting the heart without assistance, survival rates, and neurological health after a cardiac arrest.

How Is the Trial Designed?

Group I: Packed Red Blood Cells (2 units) Experimental Treatment 1 Intervention

1000 mL of packed red blood cells

Group II: Packed Red Blood Cells (1 unit) Experimental Treatment 1 Intervention

500 mL of packed red blood cells

Group III: Saline solution Placebo Group 1 Intervention

Treatment of 500 mL of normal saline.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5307870/

Pre-hospital transfusion of packed red blood cells in 147 ... Early transfusion of packed red blood cells (PRBC) has been associated with improved survival in patients with haemorrhagic shock.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434092/

Prehospital blood transfusion—experience from a specialized ... Among trauma patients, 78% were male, 49% sustained penetrating injuries, and 56% were in traumatic cardiac arrest.

3. withpower.com withpower.com/trial/phase-1-heart-arrest-7-2024-fb39e

Red Blood Cell Transfusion for Cardiac Arrest The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA).

4. journals.lww.com journals.lww.com/eccm/fulltext/2023/12000/effect_of_packed_red_blood_cell_transfusion_on_the.4.aspx

Effect of packed red blood cell transfusion on the prognosis ... Packed red blood cell transfusion does not improve prognosis or reduce mortality in patients with UGIB but may increase mortality in patients with Hb levels ...

5. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(24)00005-5/fulltext

Red Blood Cell Transfusion and Pulmonary Complications Intraoperative packed red blood cell (PRBC) transfusion during cardiac surgery is associated with increased postoperative morbidity and mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293042/

Effects of red blood cell transfusion on patients undergoing ... Packed red blood cell (pRBC) transfusion is a relatively safe and mainstay treatment commonly used in cardiac surgical patients. However, there is limited ...

7. sjtrem.biomedcentral.com sjtrem.biomedcentral.com/articles/10.1186/s13049-017-0356-2

Pre-hospital transfusion of packed red blood cells in 147 ... Early transfusion of packed red blood cells (PRBC) has been associated with improved survival in patients with haemorrhagic shock.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1443950618301288

Effect of Red Blood Cell Storage Duration on Outcome ... Retrospective reviews have found the use of stored packed red blood cells (PRBCs) in priming to be associated with increased risk of postoperative ...

9. thelancet.com thelancet.com/article/S2352-3026(22)00040-0/fulltext

Resuscitation with blood products in patients with trauma ... The composite primary outcome occurred in 128 (64%) of 199 participants randomly assigned to PRBC–LyoPlas and 136 (65%) of 210 randomly assigned ...