Packed Red Blood Cell Transfusion During Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462027
• Other study ID #: 18-01273
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: NYU Langone Health
• Contact: Anelly Gonzales
• Phone: 646-501-6923
• Email: resuscitationlab[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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.
• 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.

Other:
• Saline
Control subjects will receive 500mL of normal saline intravenously.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (in mins) to administration of Packed Red Blood Cells (PRBC)		During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)
Primary	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)
Primary	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
Primary	Change in frequency of right ventricular (RV) dilatation		Baseline, up to 20 minutes post administration of PRBC
Primary	All-cause mortality	Mortality due to all causes	Up to 30 days after the last day of study participation
Primary	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	Absolute change in peak regional oxygen saturation (rSO2)		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Absolute change in mean rSO2		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Relative change in peak rSO2		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Relative change in mean rSO2		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Relative change in peak end tidal carbon dioxide (ETCO2)		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Relative change in mean ETCO2		2 minutes prior to administration, 5 minutes post administration of PRBC
Secondary	Rate of ROSC		During CPR (up to 20 minutes)
Secondary	Proportion of patients with release of pro-inflammatory cytokines		6-72 hours after ROSC
Secondary	Proportion of patients with release markers of brain injury		6-72 hours after ROSC
Secondary	Rate of survival		At time of hospital discharge (approximately 12 days)
Secondary	Rate of survival		30 days post-CA
Secondary	Rate of survival		90 days post-CA
Secondary	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)
Secondary	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
Secondary	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