NOT_YET_RECRUITING
Packed Red Blood Cell Transfusion During Cardiac Arrest
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
🗓️ Study Start (Actual) 1 August 2024
🗓️ Primary Completion (Estimated) 1 April 2026
✅ Study Completion (Estimated) 1 April 2026
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 June 2024
  • First Submitted that Met QC Criteria 14 June 2024
  • First Posted 17 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 17 June 2024
  • Last Verified June 2024