Packed Red Blood Cell Transfusion During Cardiac Arrest

Phase 1RecruitingNCT06462027

NYU Langone Health30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cardiac Arrest

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Time (in mins) to administration of Packed Red Blood Cells (PRBC)

Time frame: 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.

Time frame: 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).

Time frame: 6-72 hours after ROSC

Change in frequency of right ventricular (RV) dilatation

Time frame: Baseline, up to 20 minutes post administration of PRBC

All-cause mortality

Mortality due to all causes

Time frame: 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).

Time frame: Up to 30 days post-Cardiac Arrest (CA)