Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Out-Of-Hospital Cardiac Arrest, Pulseless Ventricular Tachycardia, Ventricular Fibrillation
Conditions
Keywords
advanced reperfusion, mechanical cardiopulmonary resuscitation
Brief summary
This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Interventions
DEVICEEarly Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Early use of ECMO
DEVICEStandard Advanced Cardiac Life Support (ACLS) Resuscitation
Standard life support resuscitation
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults (presumed or known to be aged 18-75 years, inclusive), * An initial documented OHCA rhythm of VF/VT, * No ROSC following 3 defibrillation shocks, * Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and * Estimated transfer time from the scene to the ED or CCL of \< 30 minutes.
Exclusion criteria
* Age \< 18 years old or \> 75 years old; * Non-shockable initial OHCA rhythm (pulseless electrical activity \[PEA\] or asystole); * Valid do-not-attempt-resuscitation orders (DNAR); * Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose; * Known prisoners; * Known pregnancy; * Nursing home residents; * Unavailability of the cardiac catheterization laboratory. * Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure; * Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Approximately 25 days | Number of participants who survived to hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) Score | At hospital discharge (average of 25 days), 3 months, 6 months | 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. |
| Cerebral Performance Categories (CPC) Scale | At hospital discharge (average of 25 days), 3 months, 6 months | 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. |
| Treatment Cost | 6 months | Outcome is reported as the mean treatment cost in dollars. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard ACLS Resuscitation | Total | ECMO Facilitated Resuscitation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 9 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 21 Participants | 10 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 10.6 | 58.5 years STANDARD_DEVIATION 10 | 58.8 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 18 Participants | 6 Participants |
| Race (NIH/OMB) White | 2 Participants | 8 Participants | 6 Participants |
| Region of Enrollment United States | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 25 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 15 | 14 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 15 / 15 | 15 / 15 |
Outcome results
Primary
Survival
Number of participants who survived to hospital discharge
Time frame: Approximately 25 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ECMO Facilitated Resuscitation | Survival | 6 Participants |
| Standard ACLS Resuscitation | Survival | 1 Participants |
Secondary
Cerebral Performance Categories (CPC) Scale
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.
Time frame: At hospital discharge (average of 25 days), 3 months, 6 months
Population: All participants who completed each time point are included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ECMO Facilitated Resuscitation | Cerebral Performance Categories (CPC) Scale | Hospital Discharge | 2.5 score on a scale |
| ECMO Facilitated Resuscitation | Cerebral Performance Categories (CPC) Scale | Three Months | 1.2 score on a scale |
| ECMO Facilitated Resuscitation | Cerebral Performance Categories (CPC) Scale | Six Months | 1.2 score on a scale |
| Standard ACLS Resuscitation | Cerebral Performance Categories (CPC) Scale | Hospital Discharge | 4 score on a scale |
Secondary
Modified Rankin Scale (mRS) Score
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.
Time frame: At hospital discharge (average of 25 days), 3 months, 6 months
Population: All participants who completed each time point are included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ECMO Facilitated Resuscitation | Modified Rankin Scale (mRS) Score | Hospital Discharge | 3.8 score on a scale |
| ECMO Facilitated Resuscitation | Modified Rankin Scale (mRS) Score | Three Months | 2 score on a scale |
| ECMO Facilitated Resuscitation | Modified Rankin Scale (mRS) Score | Six Months | 1.5 score on a scale |
| Standard ACLS Resuscitation | Modified Rankin Scale (mRS) Score | Hospital Discharge | 5 score on a scale |
Secondary
Treatment Cost
Outcome is reported as the mean treatment cost in dollars.
Time frame: 6 months
Population: Outcome was not collected.