Not provided
Not provided
Not provided
Not provided
For early efficacy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMO Facilitated Resuscitation | Experimental | 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. |
|
| Standard ACLS Resuscitation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation | Device | Early use of ECMO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Number of participants who survived to hospital discharge | Approximately 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Demetris Yannopoulos, MD | University of Minnesota | Principal Investigator |
| Tom Aufderheide, MD | University of Minnesota | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33197396 | Derived | Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Advanced Cardiac Life Support (ACLS) Resuscitation | Device | Standard life support resuscitation |
|
| 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. | At hospital discharge (average of 25 days), 3 months, 6 months |
| Treatment Cost | Outcome is reported as the mean treatment cost in dollars. | 6 months |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Survival | Number of participants who survived to hospital discharge | Posted | Count of Participants | Participants | Approximately 25 days |
|
|
| ||||||||||||||||||||||||||||||
| 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. | All participants who completed each time point are included. | Posted | Mean | 95% Confidence Interval | score on a scale | At hospital discharge (average of 25 days), 3 months, 6 months |
| ||||||||||||||||||||||||||||||
| 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. | All participants who completed each time point are included. | Posted | Mean | 95% Confidence Interval | score on a scale | At hospital discharge (average of 25 days), 3 months, 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Treatment Cost | Outcome is reported as the mean treatment cost in dollars. | Outcome was not collected. | Posted | 6 months |
|
Six months following hospital discharge
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 9 | 15 | 15 | 15 | 0 | 15 |
| EG001 | 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 | 14 | 15 | 15 | 15 | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Circulatory Disorder | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Central Nervous System Disorders | Nervous system disorders | Systematic Assessment |
| ||
| CPR Trauma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Endocrine Disorders | Endocrine disorders | Systematic Assessment |
| ||
| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Kidney Disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Other Disorder | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Demetri Yannopoulos, MD | University of Minnesota | 612-626-2935 | yanno001@umn.edu |
| Nov 18, 2021 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2020 | Sep 10, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| D012151 | Resuscitation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D004638 | Emergency Treatment |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|