Cardiac ArrestNCT04491903
REBOA for Out-of-hospital Cardiac Arrest
A study testing REBOA in people with Cardiac Arrest, run by neurescue.
Trial summary
Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- REBOA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2020to 30 Nov 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Witnessed cardiac arrest
- Bystander or professional CPR within 5 minutes
- Refractory cardiac arrest
Who cannot join
- End Tidal CO2 <1,3 kPa
- Traumatic cardiac arrest
- Women with known pregnancy
- Patients with known terminal disease
- Patients with known do-not-attempt-CPR order
- Patients with overdose
About this study
Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.
The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
Read the detailed description
The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.
Data collected:
- from enrolment of the patient until hospital arrival
- every 24 hours
- at discharge or 7 days post enrollment
- at 30 days post enrollment
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
- Conditions
- Cardiac Arrest
- Being tested
- REBOA
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOAProcedure or surgery
Endovascular balloon occlusion of the aorta
| Study group | Role | What they receive |
|---|---|---|
| REBOA | Experimental | Not described Receives: Procedure: REBOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central blood pressure
Measured: 1 hour
Secondary outcomes (5)
Return of spontaneous circulation (ROSC)
Measured: 1 hour
Changes in cardiac rhythm following balloon inflation
Measured: 1 hour
During procedure - time from first needle stick to successful sheath insertion
Measured: 1 hour
During procedure - time from first needle stick to finalized balloon inflation
Measured: 1 hour
End-tidal CO2 (EtCO2)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Why it stopped: Withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- neurescue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491903
- Sponsor's protocol ID
- SafeStudy2
- Status last verified
- Apr 2021
- First submitted
- 22 Jul 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual request
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBOA for Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04491903
- Acronym / sponsor ID
- SafeStudy2
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- neurescueIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 30 Jul 2020 (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.
Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.
The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
Detailed description
The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.
Data collected:
- from enrolment of the patient until hospital arrival
- every 24 hours
- at discharge or 7 days post enrollment
- at 30 days post enrollment
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REBOA | Experimental | Procedure: REBOA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Witnessed cardiac arrest
- Bystander or professional CPR within 5 minutes
- Refractory cardiac arrest
Key exclusion criteria (6 listed)
- End Tidal CO2 <1,3 kPa
- Traumatic cardiac arrest
- Women with known pregnancy
- Patients with known terminal disease
- Patients with known do-not-attempt-CPR order
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 |
|---|---|---|
| REBOAEndovascular balloon occlusion of the aorta | Procedure or surgery | REBOA |
Primary outcome
Central blood pressure
Time frame: 1 hour
5 secondary outcomes
Return of spontaneous circulation (ROSC)
Time frame: 1 hour
Changes in cardiac rhythm following balloon inflation
Time frame: 1 hour
During procedure - time from first needle stick to successful sheath insertion
Time frame: 1 hour
During procedure - time from first needle stick to finalized balloon inflation
Time frame: 1 hour
End-tidal CO2 (EtCO2)
Time frame: 1 hour
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 4 May 2021.
- Individual participant dataSharing planned: No. Individual request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA in people with Cardiac Arrest, run by neurescue.
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 3 inclusion and 6 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 4 May 2021. 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?
Central blood pressure (time frame: 1 hour). 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 4 May 2021.