RecruitingPhase 1NCT06462027

Packed Red Blood Cell Transfusion During Cardiac Arrest

A Single-center, Randomized, Placebo Controlled Pilot Study of Packed Red Blood Cell Transfusion During Prolonged Adult In-hospital Cardiac Arrest


Sponsor

NYU Langone Health

Enrollment

30 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria2

  • Adult patients, age ≥18 and <85 years
  • Experience prolonged, non-trauma-related in-hospital cardiac arrest, defined by cessation of heartbeat and respiration requiring CPR for at least 10 minutes

Exclusion Criteria13

  • Age <18 years old
  • Age > 85 years old
  • Patients with DNR/DNI orders (Do Not Resuscitate/Do Not Intubate)
  • Patients admitted to the hospital with a cardiac arrest arising from trauma
  • Patients who achieve return of spontaneous circulation within 10 minutes of CPR
  • Inability to start study product administration within 20 minutes of cardiac arrest onset
  • Prisoners
  • Women who are known to be pregnant
  • Patients with a history of RBC antibodies or positive antibody screen prior to enrollment in the study, unless previously cross-matched units are available for transfusion.
  • Patients with ultrasound evidence of right ventricular dilatation at time of CA
  • Patients with known prior objection to receipt of blood products.
  • Patients for whom administration of additional fluid volume is contraindicated (as determined by physician responsible for care)
  • Physician objection based on concern that intervention would interfere with patient care plan

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPacked Red Blood Cells (1 unit)

500 mL of packed red blood cells administered intravenously 10-20 minutes after CA onset, provided Return of Spontaneous Circulation (ROSC) has not been achieved.

DRUGPacked Red Blood Cells (2 units)

1000 mL of packed red blood cells administered intravenously 10-20 minutes after CA onset, provided Return of Spontaneous Circulation (ROSC) has not been achieved.

OTHERSaline

Control subjects will receive 500mL of normal saline intravenously.


Locations(1)

NYU Langone Health

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06462027


Related Trials