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

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 Overview

• Status: Suspended
• Conditions: Cardiac Arrest
• Intervention / Treatment: Drug: Packed Red Blood Cells (1 unit); Drug: Packed Red Blood Cells (2 units); Other: Saline

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Packed Red Blood Cells (1 unit); 500 mL of packed red blood cells	Drug: Packed 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.
Experimental: Packed Red Blood Cells (2 units); 1000 mL of packed red blood cells	Drug: Packed 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.
Placebo Comparator: Saline solution; Treatment of 500 mL of normal saline.	Other: Saline; Control subjects will receive 500mL of normal saline intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sam Parnia, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: 18-01273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No