Packed Red Blood Cell Transfusion During Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Packed Red Blood Cells (1 unit)

500 mL of packed red blood cells

Group Type EXPERIMENTAL

Packed Red Blood Cells (1 unit)

Intervention Type 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 (2 units)

1000 mL of packed red blood cells

Group Type EXPERIMENTAL

Packed Red Blood Cells (2 units)

Intervention Type 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.

Saline solution

Treatment of 500 mL of normal saline.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Control subjects will receive 500mL of normal saline intravenously.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Saline

Control subjects will receive 500mL of normal saline intravenously.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No