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Temporary hold.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Packed Red Blood Cells (1 unit) | Experimental | 500 mL of packed red blood cells |
|
| Packed Red Blood Cells (2 units) | Experimental | 1000 mL of packed red blood cells |
|
| Saline solution | Placebo Comparator | Treatment of 500 mL of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time (in mins) to administration of Packed Red Blood Cells (PRBC) | 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. | 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). | 6-72 hours after ROSC |
| Change in frequency of right ventricular (RV) dilatation | Baseline, up to 20 minutes post administration of PRBC | |
| All-cause mortality | Mortality due to all causes | 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). | Up to 30 days post-Cardiac Arrest (CA) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in peak regional oxygen saturation (rSO2) | 2 minutes prior to administration, 5 minutes post administration of PRBC | |
| Absolute change in mean rSO2 | 2 minutes prior to administration, 5 minutes post administration of PRBC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Parnia, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data upon reasonable request. Requests should be directed to Sam.Parnia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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. |
|
| Saline | Other | Control subjects will receive 500mL of normal saline intravenously. |
|
| Relative change in peak rSO2 | 2 minutes prior to administration, 5 minutes post administration of PRBC |
| Relative change in mean rSO2 | 2 minutes prior to administration, 5 minutes post administration of PRBC |
| Relative change in peak end tidal carbon dioxide (ETCO2) | 2 minutes prior to administration, 5 minutes post administration of PRBC |
| Relative change in mean ETCO2 | 2 minutes prior to administration, 5 minutes post administration of PRBC |
| Rate of ROSC | During CPR (up to 20 minutes) |
| Proportion of patients with release of pro-inflammatory cytokines | 6-72 hours after ROSC |
| Proportion of patients with release markers of brain injury | 6-72 hours after ROSC |
| Rate of survival | At time of hospital discharge (approximately 12 days) |
| Rate of survival | 30 days post-CA |
| Rate of survival | 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). | 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). | 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). | 90 days post-CA |
| D017670 |
| Sodium Compounds |