Packed Red Blood Cell Transfusion During Cardiac Arrest

NCT06462027 | Suspended Phase 1 DMC FDA Drug

• 1 other identifier: 18-01273
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• 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

Study Arms (3)

Packed Red Blood Cells (1 unit)

EXPERIMENTAL

500 mL of packed red blood cells

Drug: Packed Red Blood Cells (1 unit)

Packed Red Blood Cells (2 units)

EXPERIMENTAL

1000 mL of packed red blood cells

Drug: Packed Red Blood Cells (2 units)

Saline solution

PLACEBO COMPARATOR

Treatment of 500 mL of normal saline.

Other: Saline

Interventions

Saline OTHER

Control subjects will receive 500mL of normal saline intravenously.

Saline solution

Packed Red Blood Cells (1 unit) DRUG

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.

Packed Red Blood Cells (1 unit)

Packed Red Blood Cells (2 units) DRUG

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.

Packed Red Blood Cells (2 units)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sam Parnia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)