Clinical trial NCT06462027: Packed Red Blood Cell Transfusion During Cardiac Arrest
Official title: A Single-center, Randomized, Placebo Controlled Pilot Study of Packed Red Blood Cell Transfusion During Prolonged Adult In-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiac Arrest
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time (in mins) to administration of Packed Red Blood Cells (PRBC)
timeFrame: During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)
measure: Frequency of antibody-mediated transfusion reactions
timeFrame: 6-72 hours after Return of Spontaneous Circulation (ROSC)
measure: Frequency of non-immune reactions
timeFrame: 6-72 hours after ROSC
measure: Change in frequency of right ventricular (RV) dilatation
timeFrame: Baseline, up to 20 minutes post administration of PRBC
measure: All-cause mortality
timeFrame: Up to 30 days after the last day of study participation
measure: Proportion of patients with unfavorable neurological outcomes
timeFrame: Up to 30 days post-Cardiac Arrest (CA)
Secondary outcomes:
measure: Absolute change in peak regional oxygen saturation (rSO2)
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Absolute change in mean rSO2
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Relative change in peak rSO2
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Relative change in mean rSO2
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Relative change in peak end tidal carbon dioxide (ETCO2)
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Relative change in mean ETCO2
timeFrame: 2 minutes prior to administration, 5 minutes post administration of PRBC
measure: Rate of ROSC
timeFrame: During CPR (up to 20 minutes)
measure: Proportion of patients with release of pro-inflammatory cytokines
timeFrame: 6-72 hours after ROSC
measure: Proportion of patients with release markers of brain injury
timeFrame: 6-72 hours after ROSC
measure: Rate of survival
timeFrame: At time of hospital discharge (approximately 12 days)
measure: Rate of survival
timeFrame: 30 days post-CA
measure: Rate of survival
timeFrame: 90 days post-CA
measure: CPC score
timeFrame: At time of hospital discharge (approximately 12 days)
measure: CPC score
timeFrame: 30 days post-CA
measure: CPC score
timeFrame: 90 days post-CA
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sam Parnia, MD
role: PRINCIPAL_INVESTIGATOR
References: