Out-of-Hospital Cardiac ArrestNCT04373122
REBOA in Out-of-hospital Cardiac Arrest
A study testing REBOA in people with Out-of-Hospital Cardiac Arrest, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Unexpected cardiac arrest is a frequent and devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- REBOA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jun 2021to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from refractory Out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin, defined as failure to achieve stable ROSC within 10 min of fully established standard care (ALS) which do not qualify for extracorporeal cardiac life support (e-CPR).
- Witnessed Arrest
- Interval from collapse to initiation of sufficient (lay) CPR less than 5 minutes
Who cannot join
- Patients whose underlying disease limit survival and resuscitation measures are stopped after initial assessment, or evaluation reveals futile clinical situation
- Patients with advanced directives or living will which excludes CPR
- Age < 18 years (device certified >18 years)
- Qualifying for other treatment options, namely eCPR (CPR with extracorporeal membrane oxygenation (ECMO) as life assist device)
- Unwitnessed arrest with asystole as first documented rhythm
- etCO2 below 15mmHg
Show all 10Show fewer
- Patients in whom no femoral arterial access site cannot accommodate a 7 Fr (minimum) introducer sheath
- Known to have an aortic diameter larger than 32 mm
- Evidence or suspicion of thoracic trauma
- Inability to guarantee standard ALS measures during performance of the REBOA maneuver
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Departement of Intensive Care Medicine - University Hospital Bern - Inselspital
Bern, 3010
About this study
Official title: CPR-REBOA: Improving Outcome of Prehospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
Unexpected cardiac arrest is a frequent and devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy. With CPR and advanced life support, blood and oxygen delivery to heart and brain is preserved until circulation is restored. During CPR, coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. Existing efforts to reduce mortality and morbidity focus on rapid recognition of cardiac arrest, initiation of basic and advanced life support (ALS), and optimization of post-arrest care.
Clamping the descending aorta during cardio-pulmonary resuscitation (CPR) should redistribute the blood flow towards brain and heart. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function.
Read more
In humans, occlusion of the aorta using a REBOA catheter in the management of non-compressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. The investigators have developed a protocol for the reliable and safe placement of a REBOA-catheter during cardiac arrest in a clinical setting (see ClinicalTrials.gov Identifier: NCT03664557).
Damage to heart and brain from lack of oxygen supply occurs during the first minutes following cardiac arrest. It is therefore crucial to apply any measure to improve efficacy of CPR early in the course of events and therapy. After proving feasibility in a clinical setting in the trial mentioned above, the next logical step and specific goal of this study is to transfer this protocol to the preclinical setting, and to investigate the effect of temporary endovascular occlusion of the descending aorta on the efficacy of CPR early in the course of treatment of out-of hospital cardiac arrest by means of an increase in blood pressure.
Read the detailed description
Unexpected cardiac arrest is a devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy (HIE). As outcome after cardiac arrest is depending on time and amount of oxygen delivery to heart and brain, preserving myocardial and cerebral perfusion in the event of cardiac arrest by the means of effective cardio-pulmonary resuscitation (CPR) is of utmost importance. During CPR Coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. The absence of ROSC despite prolonged high quality and efficient initial basic life support (BLS) followed by traditional ALS ends finally in neuronal damage and death.
For those patients not qualifying for eCPR or in areas where this highly invasive approach is not readily available, existing efforts to reduce mortality and morbidity focus on rapid recognition of cardiac arrest, initiation of basic and advanced life support (ALS), and optimization of post-arrest care.
Clamping the descending aorta during cardio-pulmonary resuscitation (CPR) should redistribute the blood flow towards brain and heart. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function.
In humans, occlusion of the aorta using a REBOA catheter in the management of non-compressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. For an ongoing study evaluating its feasibility, the investigators have developed a protocol for the reliable and safe placement of a REBOA-catheter during cardiac arrest in a clinical setting (see ClinicalTrials.gov Identifier: NCT03664557).
Damage to heart and brain from lack of oxygen supply occurs during the first minutes following cardiac arrest. It is therefore crucial to apply any measure to improve efficacy of CPR early in the course of events and therapy. After proving feasibility in a clinical setting in the trial mentioned above, the next logical step and specific goal of this study is to transfer this protocol to the preclinical setting, and to investigate the effect of temporary endovascular occlusion of the descending aorta on the efficacy of CPR early in the course of treatment of out-of hospital cardiac arrest by means of an increase in blood pressure.
The objectives are to investigate the effect of resuscitative endovascular balloon occlusion of the descending aorta early in the course of cardiac arrest therapy on blood pressure, cerebral oxygenation and endtidalCO2- Data collection allowing for sample calculation for a large outcome study
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- REBOA
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOADevice
Resuscitative Endovascular Balloon Occlusion of the Aorta
| Study group | Role | What they receive |
|---|---|---|
| REBOA | Experimental | Insertion of the ER-REBOA Catheter during ongoing CPR Receives: Device: REBOA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure
Increase of blood pressure after balloon occlusion of the aorta
Measured: 10 minutes
Secondary outcomes (2)
Change of NIRS
Increase of NIRS (near-infrared reflectance spectroscopy) after balloon occlusion of the aorta
Measured: 10 minutes
Change of etCO2
Increase of etCO2 (end-tidal CO2) after balloon occlusion of the aorta
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start7 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- City of Bern
- Responsible party
- Sponsor
- Investigators
- Anja Levis, MD, Principal investigator, University of Bern, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373122
- Sponsor's protocol ID
- 2019-02039
- Other IDs
- 2019
- Status last verified
- Mar 2023
- First submitted
- 30 Apr 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPR-REBOA: Improving Outcome of Prehospital Cardiopulmonary Resuscitation With Balloon Occlusion of the Descending Aorta
- ClinicalTrials.gov ID
- NCT04373122
- Acronym / sponsor ID
- 2019-02039
- Conditions
- Out-of-Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- City of Bern
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 May 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.
Unexpected cardiac arrest is a frequent and devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy. With CPR and advanced life support, blood and oxygen delivery to heart and brain is preserved until circulation is restored. During CPR, coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. Existing efforts to reduce mortality and morbidity focus on rapid recognition of cardiac arrest, initiation of basic and advanced life support (ALS), and optimization of post-arrest care.
Clamping the descending aorta during cardio-pulmonary resuscitation (CPR) should redistribute the blood flow towards brain and heart. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function.
In humans, occlusion of the aorta using a REBOA catheter in the management of non-compressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. The investigators have developed a protocol for the reliable and safe placement of a REBOA-catheter during cardiac arrest in a clinical setting (see ClinicalTrials.gov Identifier: NCT03664557).
Damage to heart and brain from lack of oxygen supply occurs during the first minutes following cardiac arrest. It is therefore crucial to apply any measure to improve efficacy of CPR early in the course of events and therapy. After proving feasibility in a clinical setting in the trial mentioned above, the next logical step and specific goal of this study is to transfer this protocol to the preclinical setting, and to investigate the effect of temporary endovascular occlusion of the descending aorta on the efficacy of CPR early in the course of treatment of out-of hospital cardiac arrest by means of an increase in blood pressure.
Detailed description
Unexpected cardiac arrest is a devastating event with a high mortality and morbidity. Half of the patients who survive to ICU admission ultimately die because of hypoxic-ischemic encephalopathy (HIE). As outcome after cardiac arrest is depending on time and amount of oxygen delivery to heart and brain, preserving myocardial and cerebral perfusion in the event of cardiac arrest by the means of effective cardio-pulmonary resuscitation (CPR) is of utmost importance. During CPR Coronary perfusion pressure is a significant predictor of increased rates of return of spontaneous circulation (ROSC) and survival to hospital discharge, while cerebral perfusion pressure is crucial for good neurologic outcome. The absence of ROSC despite prolonged high quality and efficient initial basic life support (BLS) followed by traditional ALS ends finally in neuronal damage and death.
For those patients not qualifying for eCPR or in areas where this highly invasive approach is not readily available, existing efforts to reduce mortality and morbidity focus on rapid recognition of cardiac arrest, initiation of basic and advanced life support (ALS), and optimization of post-arrest care.
Clamping the descending aorta during cardio-pulmonary resuscitation (CPR) should redistribute the blood flow towards brain and heart. Animal models of continuous balloon occlusion of the aorta in non-traumatic cardiac arrest have shown meaningful increases in coronary artery blood flow, coronary artery perfusion pressure and carotid blood flow, leading to improved rates of ROSC, 48h-survival and neurological function.
In humans, occlusion of the aorta using a REBOA catheter in the management of non-compressible abdominal or pelvic hemorrhage has shown improvements in hemodynamic profiles and has proved to be feasible in both, clinical and preclinical settings for trauma patients in hemorrhagic shock. These promising data provide an opportunity to improve outcome after cardiac arrest in humans too. For an ongoing study evaluating its feasibility, the investigators have developed a protocol for the reliable and safe placement of a REBOA-catheter during cardiac arrest in a clinical setting (see ClinicalTrials.gov Identifier: NCT03664557).
Damage to heart and brain from lack of oxygen supply occurs during the first minutes following cardiac arrest. It is therefore crucial to apply any measure to improve efficacy of CPR early in the course of events and therapy. After proving feasibility in a clinical setting in the trial mentioned above, the next logical step and specific goal of this study is to transfer this protocol to the preclinical setting, and to investigate the effect of temporary endovascular occlusion of the descending aorta on the efficacy of CPR early in the course of treatment of out-of hospital cardiac arrest by means of an increase in blood pressure.
The objectives are to investigate the effect of resuscitative endovascular balloon occlusion of the descending aorta early in the course of cardiac arrest therapy on blood pressure, cerebral oxygenation and endtidalCO2- Data collection allowing for sample calculation for a large outcome study
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 | Device: REBOAInsertion of the ER-REBOA Catheter during ongoing CPR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from refractory Out-of-hospital cardiac arrest (OHCA) of presumed cardiac origin, defined as failure to achieve stable ROSC within 10 min of fully established standard care (ALS) which do not qualify for extracorporeal cardiac life support (e-CPR).
- Witnessed Arrest
- Interval from collapse to initiation of sufficient (lay) CPR less than 5 minutes
Key exclusion criteria (10 listed)
- Patients whose underlying disease limit survival and resuscitation measures are stopped after initial assessment, or evaluation reveals futile clinical situation
- Patients with advanced directives or living will which excludes CPR
- Age < 18 years (device certified >18 years)
- Qualifying for other treatment options, namely eCPR (CPR with extracorporeal membrane oxygenation (ECMO) as life assist device)
- Unwitnessed arrest with asystole as first documented rhythm
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 |
|---|---|---|
| REBOAResuscitative Endovascular Balloon Occlusion of the Aorta | Device | REBOA |
Primary outcome
Change of blood pressure
Time frame: 10 minutes
Increase of blood pressure after balloon occlusion of the aorta
2 secondary outcomes
Change of NIRS
Time frame: 10 minutes
Change of etCO2
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- 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.
Anja Levis, MD principal investigator
University of Bern, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA in people with Out-of-Hospital Cardiac Arrest, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 10 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anja Levis, MD (+41316327855, Anja.Levis@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of blood pressure (time frame: 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 9 Mar 2023.