An interventional study of Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation and Standard Advanced Cardiac Life Support (ACLS) Resuscitation in Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication and Ventricular Fibrillation, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 557 interventional studies indexed under Heart Arrest.
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Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
Regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, patients will enter the Cardiac Catheterization Laboratory (CCL) for expeditious VAECMO initiation, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated 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.
Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Early use of ECMO
Standard life support resuscitation
Survival
Number of participants who survived to hospital discharge
Time frame: Approximately 25 days
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
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
Treatment Cost
Outcome is reported as the mean treatment cost in dollars.
Time frame: 6 months
| Milestone | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation |
|---|---|---|
| Started | 15 | 15 |
| Completed | 14 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Number of participants who survived to hospital discharge
| Participants | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation |
|---|---|---|
| Survival | 6 | 1 |
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.
| score on a scale | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation |
|---|---|---|
| Hospital Discharge | 3.8 (3 to 4.6) | 5 (NA to NA) |
| Three Months | 2 (.9 to 3.4) | — |
| Six Months | 1.5 (.4 to 2.6) | — |
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.
| score on a scale | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation |
|---|---|---|
| Hospital Discharge | 2.5 (1.9 to 3.1) | 4 (NA to NA) |
| Three Months | 1.2 (.7 to 1.6) | — |
| Six Months | 1.2 (.7 to 1.6) | — |
Outcome is reported as the mean treatment cost in dollars.
No measurements were reported for this outcome.
Collected over Six months following hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ECMO Facilitated Resuscitation | 9/15 (60%) | 15/15 (100%) | 0/15 (0%) |
| Standard ACLS Resuscitation | 14/15 (93.3%) | 15/15 (100%) | 0/15 (0%) |
| Event | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation |
|---|---|---|
| Circulatory DisorderBlood and lymphatic system disorders | 15/15 | 15/15 |
| Endocrine DisordersEndocrine disorders | 13/15 | 10/15 |
| Respiratory DisorderRespiratory, thoracic and mediastinal disorders | 13/15 | 2/15 |
| CPR TraumaInjury, poisoning and procedural complications | 11/15 | 1/15 |
| Kidney DisordersRenal and urinary disorders | 10/15 | 1/15 |
| Central Nervous System DisordersNervous system disorders | 9/15 | 1/15 |
| Gastrointestinal DisorderGastrointestinal disorders | 9/15 | 2/15 |
| Other DisorderGeneral disorders | 9/15 | 2/15 |
| BleedingBlood and lymphatic system disorders | 7/15 | 0/15 |
| InfectionInfections and infestations | 5/15 | 0/15 |
| Age, Categorical(Participants) | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 11 | 21 |
| >=65 years | 5 | 4 | 9 |
| Age, Continuous(years) | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation | Total |
|---|---|---|---|
| Mean | 58.8 ± 9.7 | 57.1 ± 10.6 | 58.5 ± 10 |
| Sex: Female, Male(Participants) | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 14 | 11 | 25 |
| Race (NIH/OMB)(Participants) | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 6 | 2 | 8 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 6 | 12 | 18 |
| Region of Enrollment(participants) | ECMO Facilitated Resuscitation | Standard ACLS Resuscitation | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
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