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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Anelly Gonzales
resuscitationlab@nyulangone.org
646-501-6923
Backup
Natalia Leontovich
resuscitationlab@nyulangone.org
646-501-6923
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
Experimental: Packed Red Blood Cells (1 unit)
500 mL of packed red blood cells
Experimental: Packed Red Blood Cells (2 units)
1000 mL of packed red blood cells
Placebo_comparator: Saline solution
Treatment of 500 mL of normal saline.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov