Trial Outcomes & Findings for Advanced Reperfusion Strategies for Refractory Cardiac Arrest (NCT NCT03880565)
NCT ID: NCT03880565
Last Updated: 2022-03-10
Results Overview
Number of participants who survived to hospital discharge
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Approximately 25 days
Results posted on
2022-03-10
Participant Flow
Participant milestones
| Measure |
ECMO Facilitated Resuscitation
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ECMO Facilitated Resuscitation
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Advanced Reperfusion Strategies for Refractory Cardiac Arrest
Baseline characteristics by cohort
| Measure |
ECMO Facilitated Resuscitation
n=15 Participants
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
n=15 Participants
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 25 daysNumber of participants who survived to hospital discharge
Outcome measures
| Measure |
ECMO Facilitated Resuscitation
n=15 Participants
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
n=15 Participants
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Survival
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At hospital discharge (average of 25 days), 3 months, 6 monthsPopulation: All participants who completed each time point are included.
mRS scale ranges from 0 (no residual symptoms) to 6 (dead). Scores of 3 (the patient has moderate disability), 2 (the patient has slight disability), 1 (the patient has no significant disability), and 0 indicate favorable outcome. Higher scores on the scale indicate more severe disability. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Outcome measures
| Measure |
ECMO Facilitated Resuscitation
n=15 Participants
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
n=15 Participants
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Modified Rankin Scale (mRS) Score
Hospital Discharge
|
3.8 score on a scale
Interval 3.0 to 4.6
|
5 score on a scale
There is only one participant in this group.
|
|
Modified Rankin Scale (mRS) Score
Three Months
|
2 score on a scale
Interval 0.9 to 3.4
|
—
|
|
Modified Rankin Scale (mRS) Score
Six Months
|
1.5 score on a scale
Interval 0.4 to 2.6
|
—
|
SECONDARY outcome
Timeframe: At hospital discharge (average of 25 days), 3 months, 6 monthsPopulation: All participants who completed each time point are included.
CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status. Higher scores on the scale indicate worse cerebral performance. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Outcome measures
| Measure |
ECMO Facilitated Resuscitation
n=15 Participants
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
n=15 Participants
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Cerebral Performance Categories (CPC) Scale
Hospital Discharge
|
2.5 score on a scale
Interval 1.9 to 3.1
|
4 score on a scale
There is only one participant in this group.
|
|
Cerebral Performance Categories (CPC) Scale
Three Months
|
1.2 score on a scale
Interval 0.7 to 1.6
|
—
|
|
Cerebral Performance Categories (CPC) Scale
Six Months
|
1.2 score on a scale
Interval 0.7 to 1.6
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Outcome was not collected.
Outcome is reported as the mean treatment cost in dollars.
Outcome measures
Outcome data not reported
Adverse Events
ECMO Facilitated Resuscitation
Serious events: 15 serious events
Other events: 0 other events
Deaths: 9 deaths
Standard ACLS Resuscitation
Serious events: 15 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
ECMO Facilitated Resuscitation
n=15 participants at risk
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO
|
Standard ACLS Resuscitation
n=15 participants at risk
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
46.7%
7/15 • Number of events 7 • Six months following hospital discharge
|
0.00%
0/15 • Six months following hospital discharge
|
|
Blood and lymphatic system disorders
Circulatory Disorder
|
100.0%
15/15 • Number of events 45 • Six months following hospital discharge
|
100.0%
15/15 • Number of events 20 • Six months following hospital discharge
|
|
Nervous system disorders
Central Nervous System Disorders
|
60.0%
9/15 • Number of events 12 • Six months following hospital discharge
|
6.7%
1/15 • Number of events 3 • Six months following hospital discharge
|
|
Injury, poisoning and procedural complications
CPR Trauma
|
73.3%
11/15 • Number of events 198 • Six months following hospital discharge
|
6.7%
1/15 • Number of events 2 • Six months following hospital discharge
|
|
Endocrine disorders
Endocrine Disorders
|
86.7%
13/15 • Number of events 20 • Six months following hospital discharge
|
66.7%
10/15 • Number of events 12 • Six months following hospital discharge
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
60.0%
9/15 • Number of events 10 • Six months following hospital discharge
|
13.3%
2/15 • Number of events 2 • Six months following hospital discharge
|
|
Infections and infestations
Infection
|
33.3%
5/15 • Number of events 6 • Six months following hospital discharge
|
0.00%
0/15 • Six months following hospital discharge
|
|
Renal and urinary disorders
Kidney Disorders
|
66.7%
10/15 • Number of events 18 • Six months following hospital discharge
|
6.7%
1/15 • Number of events 1 • Six months following hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
86.7%
13/15 • Number of events 19 • Six months following hospital discharge
|
13.3%
2/15 • Number of events 4 • Six months following hospital discharge
|
|
General disorders
Other Disorder
|
60.0%
9/15 • Number of events 13 • Six months following hospital discharge
|
13.3%
2/15 • Number of events 3 • Six months following hospital discharge
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place