Packed Red Blood Cell Transfusion During Cardiac Arrest

NYU Langone Health

Status and phase: Enrolling; Phase 1

Conditions: Cardiac Arrest

Treatments: Drug: Packed Red Blood Cells (2 units); Other: Saline; Drug: Packed Red Blood Cells (1 unit)

Study type: Interventional

Funder types: Other

Identifiers

NCT06462027

18-01273

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Packed Red Blood Cells (1 unit)

Experimental group

Description:

500 mL of packed red blood cells

Treatment:

Drug: Packed Red Blood Cells (1 unit)

Packed Red Blood Cells (2 units)

Experimental group

Description:

1000 mL of packed red blood cells

Treatment:

Drug: Packed Red Blood Cells (2 units)

Saline solution

Placebo Comparator group

Description:

Treatment of 500 mL of normal saline.

Treatment:

Other: Saline