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

Trial Summary

What is the purpose of this trial?

The purpose of this pilot interventional study is to collect preliminary data on administering packed red blood cell (PRBC) during cardiac arrest (CA). The primary objective is to assess the feasibility of PRBC transfusion during cardiac CA to help optimize the methods required to augment cerebral and other vital organ oxygen delivery during cardiopulmonary resuscitation (CPR). The secondary objectives are to assess the effect of PRBC transfusion during prolonged cardiac arrests on cerebral oxygenation, end tidal carbon dioxide (ETCO2), return of spontaneous circulation (ROSC), survival to discharge, biomarkers of neural injury and inflammation, and neurological outcomes at hospital discharge, 30 days post-CA, and 90 days post-CA.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Packed Red Blood Cells for cardiac arrest?

Research shows that early transfusion of packed red blood cells can improve survival in patients with severe bleeding, which suggests it might help in situations like cardiac arrest where blood flow is critical. ^{1 2 3 4 5}

Is red blood cell transfusion generally safe for humans?

Transfusions of packed red blood cells (PRBCs) can increase the risk of acute respiratory distress syndrome (ARDS), a serious lung condition, especially in critically ill and trauma patients. Overtransfusion, or giving too many red blood cells, can also lead to worse outcomes in trauma patients. ^{1 6 7 8 9}

How is the treatment of packed red blood cells unique for cardiac arrest?

Packed red blood cells (PRBCs) are used in emergencies to quickly increase oxygen-carrying capacity in the blood, which can be crucial during cardiac arrest. Unlike other treatments, PRBC transfusions directly address severe blood loss or low red blood cell counts, but they come with risks like increased chance of complications and are not typically a standard treatment for cardiac arrest. ^{5 6 8 10 11}

Research Team

Sam Parnia, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 am between 18 and 85 years old.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The epidemiology of overtransfusion of red cells in trauma resuscitation patients in the context of a mature massive transfusion protocol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pre-hospital transfusion of packed red blood cells in 147 patients from a UK helicopter emergency medical service. [2018]

3. Spain pubmed.ncbi.nlm.nih.gov

[Blood transfusion during heart surgery. A retrospective nested case-control study]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Shorter times to packed red blood cell transfusion are associated with decreased risk of death in traumatically injured patients. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Mortality risk is dose-dependent on the number of packed red blood cell transfused after coronary artery bypass graft. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Red blood cell transfusions and the risk of acute respiratory distress syndrome among the critically ill: a cohort study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Early packed red blood cell transfusion and acute respiratory distress syndrome after trauma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Packed red blood cell transfusion in the intensive care unit: limitations and consequences. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Transfusion of packed red blood cells in patients with ischemic heart disease. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

Blood administration in helicopter emergency medical services patients associated with hypothermia. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Continuous monitoring of arterial blood gases and pH during intraoperative rapid blood administration using a Paratrend sensor. [2018]