Cardiac ArrestPhase 1NCT06462027
Packed Red Blood Cell Transfusion During Cardiac Arrest
A Phase 1 study testing Packed Red Blood Cells (1 unit), Packed Red Blood Cells (2 units) and Saline in people with Cardiac Arrest, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Packed Red Blood Cells (1 unit), Packed Red Blood Cells (2 units) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Sep 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Placebo Controlled Pilot Study of Packed Red Blood Cell Transfusion During Prolonged Adult In-hospital 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
- Being tested
- Packed Red Blood Cells (1 unit), Packed Red Blood Cells (2 units), Saline
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Packed Red Blood Cells (1 unit)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)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.
SalineOther
Control subjects will receive 500mL of normal saline intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Packed Red Blood Cells (1 unit) | Experimental | 500 mL of packed red blood cells Receives: Drug: Packed Red Blood Cells (1 unit) |
| Packed Red Blood Cells (2 units) | Experimental | 1000 mL of packed red blood cells Receives: Drug: Packed Red Blood Cells (2 units) |
| Saline solution | Placebo comparator | Treatment of 500 mL of normal saline. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in mins) to administration of Packed Red Blood Cells (PRBC)
Measured: During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)
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.
Measured: 6-72 hours after Return of Spontaneous Circulation (ROSC)
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).
Measured: 6-72 hours after ROSC
Change in frequency of right ventricular (RV) dilatation
Measured: Baseline, up to 20 minutes post administration of PRBC
All-cause mortality
Mortality due to all causes
Measured: Up to 30 days after the last day of study participation
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).
Measured: Up to 30 days post-Cardiac Arrest (CA)
Secondary outcomes (15)
Absolute change in peak regional oxygen saturation (rSO2)
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Absolute change in mean rSO2
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in peak rSO2
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in mean rSO2
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in peak end tidal carbon dioxide (ETCO2)
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in mean ETCO2
Measured: 2 minutes prior to administration, 5 minutes post administration of PRBC
Rate of ROSC
Measured: During CPR (up to 20 minutes)
Proportion of patients with release of pro-inflammatory cytokines
Measured: 6-72 hours after ROSC
Proportion of patients with release markers of brain injury
Measured: 6-72 hours after ROSC
Rate of survival
Measured: At time of hospital discharge (approximately 12 days)
Rate of survival
Measured: 30 days post-CA
Rate of survival
Measured: 90 days post-CA
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).
Measured: At time of hospital discharge (approximately 12 days)
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).
Measured: 30 days post-CA
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).
Measured: 90 days post-CA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Why it stopped: Temporary hold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Parnia, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462027
- Sponsor's protocol ID
- 18-01273
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Placebo Controlled Pilot Study of Packed Red Blood Cell Transfusion During Prolonged Adult In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06462027
- Acronym / sponsor ID
- 18-01273
- Conditions
- Cardiac Arrest
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary hold.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Packed Red Blood Cells (1 unit) | Experimental | Drug: Packed Red Blood Cells (1 unit)500 mL of packed red blood cells |
| Packed Red Blood Cells (2 units) | Experimental | Drug: Packed Red Blood Cells (2 units)1000 mL of packed red blood cells |
| Saline solution | Placebo comparator | Other: SalineTreatment of 500 mL of normal saline. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Packed Red Blood Cells (1 unit) |
| 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. | Drug | Packed Red Blood Cells (2 units) |
| SalineControl subjects will receive 500mL of normal saline intravenously. | Other | Saline solution |
Primary outcome
Time (in mins) to administration of Packed Red Blood Cells (PRBC)
Time frame: During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)
Frequency of antibody-mediated transfusion reactions
Time frame: 6-72 hours after Return of Spontaneous Circulation (ROSC)
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.
Frequency of non-immune reactions
Time frame: 6-72 hours after ROSC
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).
Change in frequency of right ventricular (RV) dilatation
Time frame: Baseline, up to 20 minutes post administration of PRBC
All-cause mortality
Time frame: Up to 30 days after the last day of study participation
Mortality due to all causes
Proportion of patients with unfavorable neurological outcomes
Time frame: Up to 30 days post-Cardiac Arrest (CA)
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).
15 secondary outcomes
Absolute change in peak regional oxygen saturation (rSO2)
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Absolute change in mean rSO2
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in peak rSO2
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in mean rSO2
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in peak end tidal carbon dioxide (ETCO2)
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Relative change in mean ETCO2
Time frame: 2 minutes prior to administration, 5 minutes post administration of PRBC
Rate of ROSC
Time frame: During CPR (up to 20 minutes)
Proportion of patients with release of pro-inflammatory cytokines
Time frame: 6-72 hours after ROSC
Proportion of patients with release markers of brain injury
Time frame: 6-72 hours after ROSC
Rate of survival
Time frame: At time of hospital discharge (approximately 12 days)
Rate of survival
Time frame: 30 days post-CA
Rate of survival
Time frame: 90 days post-CA
CPC score
Time frame: At time of hospital discharge (approximately 12 days)
CPC score
Time frame: 30 days post-CA
CPC score
Time frame: 90 days post-CA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sam.Parnia@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Related trials for Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
RecruitingObservational study
Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Cardiac Arrest
Cardiac Arrest
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Parnia, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Packed Red Blood Cells (1 unit), Packed Red Blood Cells (2 units) and Saline in people with Cardiac Arrest, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (in mins) to administration of Packed Red Blood Cells (PRBC) (time frame: During Cardiopulmonary Resuscitation (CPR) (up to 20 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.