Cardiac Arrest, Out-Of-HospitalUP-FRONTNCT05236920
Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
A study testing Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device in people with Cardiac Arrest, Out-Of-Hospital and Ventricular Fibrillation, run by University of Alabama at Birmingham.
Trial summary
Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital, Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apparent age between 18 - 70 years.
- OHCA defined as receiving professional CPR or AED defibrillation
- OHCA witnessed by bystanders or professional rescuers / UED personnel
- VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA
- Total time pulseless > 10 minutes
Who cannot join
- Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living
- Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)
- Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest
- Do-Not-Resuscitate order or comfort care measures in place prior to enrollment
- Special populations (pregnant, prisoner, or cognitively impaired)
- Total time pulseless greater than 20 minutes
- Inability to determine when cardiac arrest occurred (or for OHCA arriving to UED via EMS, time of 911 call) and the time elapsed since
About this study
Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).
Read the detailed description
Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device.
The aims of UPFRONT are:
- To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA
- To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.
- Being tested
- Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device
- Keywords
- cardiac arrest, out of hospital cardiac arrest, REBOA
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation, Tachycardia, Ventricular, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter deviceDevice
Also called REBOA procedure
In-hospital use of a REBOA catheter device during advanced cardiac life support
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) |
| Standard Care Plus Intervention | Experimental | Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention Receives: Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to successful deployment of device
The device is successfully deployed when it raises the mean arterial pressure
Measured: Up to 10 minutes
Secondary outcomes (1)
Return of spontaneous circulation (ROSC)
ROSC is when the heart begins beating on its own
Measured: Up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: Study will not take place at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael C. Kurz, University of Alabama at Birmingham
- Investigators
- Michael C Kurz, MD, Principal investigator, Professor and Vice-Chair for Research, Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236920
- Sponsor's protocol ID
- 300007924
- Acronym
- UP-FRONT
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The investigator has no plans to share individual participant data with other researchers. Any future use of the data will be proposed to and approved by the Principal Investigator, and will require IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility and Procedural Feasibility of REBOA Operationalized for Non-Trauma Application (UP-FRONT)
- ClinicalTrials.gov ID
- NCT05236920
- Acronym / sponsor ID
- UP-FRONT / 300007924
- Keywords
- cardiac arrest, out of hospital cardiac arrest, REBOA
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will not take place at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center randomized-controlled trial in out-of-hospital cardiac arrest (OHCA) patients. This study will investigate the feasibility and utility of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure using a REBOA catheter device in patients who have experienced an OHCA and have not regained return of spontaneous circulation (ROSC).
Detailed description
Victims arriving to, or experiencing witnessed Ventricular Fibrillation (VF) or Ventricular Tachycardia (VT) out of hospital cardiac arrest in, the UAB emergency department with greater than 10 minutes of conventional ACLS will be eligible. The study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (ACLS), or ACLS plus the administration of a REBOA catheter device.
The aims of UPFRONT are:
- To describe the feasibility of rapid deployment of a REBOA catheter device in the setting of OHCA
- To evaluate the utility of a REBOA catheter device to achieve ROSC in the setting of OHCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 40 subjects will be randomized to standard care, or standard care plus administration of the device.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) |
| Standard Care Plus Intervention | Experimental | Device: Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter deviceParticipants randomized to this arm will receive standard care for cardiac arrest, which consists of advanced cardiovascular life support (ACLS) plus the study intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Apparent age between 18 - 70 years.
- OHCA defined as receiving professional CPR or AED defibrillation
- OHCA witnessed by bystanders or professional rescuers / UED personnel
- VT/VF as the presenting rhythm for OHCA or clearly documented VT/VF during OHCA
- Total time pulseless > 10 minutes
Key exclusion criteria (7 listed)
- Obvious Pre-existing neurocognitive impairment precluding independent activities of daily living
- Obvious or suspicion of anatomic abnormality preventing successful deployment of REBOA device (i.e. previous vascular surgery in access region, dialysis graft, etc.)
- Clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest
- Do-Not-Resuscitate order or comfort care measures in place prior to enrollment
- Special populations (pregnant, prisoner, or cognitively impaired)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter deviceAlso: REBOA procedureIn-hospital use of a REBOA catheter device during advanced cardiac life support | Device | Standard Care Plus Intervention |
Primary outcome
Time to successful deployment of device
Time frame: Up to 10 minutes
The device is successfully deployed when it raises the mean arterial pressure
1 secondary outcome
Return of spontaneous circulation (ROSC)
Time frame: Up to 60 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No. The investigator has no plans to share individual participant data with other researchers. Any future use of the data will be proposed to and approved by the Principal Investigator, and will require IRB approval.
Related trials for Cardiac Arrest, Out-Of-Hospital
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Kurz, MD principal investigator
Professor and Vice-Chair for Research, Department of Emergency Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Resuscitative Endovascular balloon occlusion of the aorta using a REBOA catheter device in people with Cardiac Arrest, Out-Of-Hospital and Ventricular Fibrillation, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to successful deployment of device (time frame: Up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.