Packed Red Blood Cell Transfusion During Cardiac Arrest
NCT Number: NCT06462027
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Cardiac Arrest
Interventions: DRUG: Packed Red Blood Cells (1 unit)|DRUG: Packed Red Blood Cells (2 units)|OTHER: Saline
Sponsor: NYU Langone Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2026-04-01
Locations: NYU Langone Health, New York, New York, 10016, United States

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.

Primary Outcome Measures: Time (in mins) to administration of Packed Red Blood Cells (PRBC), During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)|Frequency of antibody-mediated transfusion reactions, Outcome measure will be evaluated for the occurrence of intravascular and extravascular hemolytic reactions by measuring fibrinogen, D-dimer, platelet count, peripheral blood smear, and serum haptoglobin., 6-72 hours after Return of Spontaneous Circulation (ROSC)|Frequency of non-immune reactions, Non-immune reactions include Transfusion Associated Circulatory Overload (TACO) and Transfusion-Related Acute Lung Injury (TRALI) as determined by the Data Safety Monitoring Committee (DSMC)., 6-72 hours after ROSC|Change in frequency of right ventricular (RV) dilatation, Baseline, up to 20 minutes post administration of PRBC|All-cause mortality, Mortality due to all causes, Up to 30 days after the last day of study participation|Proportion of patients with unfavorable neurological outcomes, The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death)., Up to 30 days post-Cardiac Arrest (CA)
Secondary Outcome Measures: Absolute change in peak regional oxygen saturation (rSO2), 2 minutes prior to administration, 5 minutes post administration of PRBC|Absolute change in mean rSO2, 2 minutes prior to administration, 5 minutes post administration of PRBC|Relative change in peak rSO2, 2 minutes prior to administration, 5 minutes post administration of PRBC|Relative change in mean rSO2, 2 minutes prior to administration, 5 minutes post administration of PRBC|Relative change in peak end tidal carbon dioxide (ETCO2), 2 minutes prior to administration, 5 minutes post administration of PRBC|Relative change in mean ETCO2, 2 minutes prior to administration, 5 minutes post administration of PRBC|Rate of ROSC, During CPR (up to 20 minutes)|Proportion of patients with release of pro-inflammatory cytokines, 6-72 hours after ROSC|Proportion of patients with release markers of brain injury, 6-72 hours after ROSC|Rate of survival, At time of hospital discharge (approximately 12 days)|Rate of survival, 30 days post-CA|Rate of survival, 90 days post-CA|CPC score, The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death)., At time of hospital discharge (approximately 12 days)|CPC score, The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death)., 30 days post-CA|CPC score, The Cerebral Performance Category (CPC) score is a five-point scale used to assess neurological outcome after cardiac arrest and other events. Scores range from 1 to 5, a score of 1 or 2 is considered a favorable outcome, and scores of 3, 4, or 5 are considered an unfavorable outcome (severe neurological disability, persistent vegetative state or death)., 90 days post-CA