- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596514
Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest (REBOARREST)
A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest
The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.
Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.
Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).
This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial.
Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.
The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients.
If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andreas Jørstad Krüger, md phd
- Phone Number: +47 908 62 586
- Email: Andreas.kruger@ntnu.no
Study Contact Backup
- Name: Jostein Rødseth Brede, md
- Phone Number: +47 994 45 914
- Email: Jostein.brede@norskluftambulanse.no
Study Locations
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Trondheim, Norway, 7030
- Recruiting
- St Olavs Hospital
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Contact:
- Jostein R Brede, md phd
- Email: jostein.brede@norskluftambulanse.no
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- out-of-hospital cardiac arrest
- non-traumatic cardiac arrest
- less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support
- advanced cardiac life support is established and can be continued
Exclusion Criteria:
- traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches
- accidental hypothermia with temperature < 32 0C
- suspected cerebral hemorrhage as etiology of the arrest
- suspected non-traumatic hemorrhage as etiology of the arrest
- pregnancy, obvious or suspected
- patient included to the study site's E-CPR protocol
- other factors as decided by the treatment team (environmental factors, safety factors and others)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group - REBOA
Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved
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Resuscitative endovascular balloon occlusion of the aorta (REBOA)
Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines
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Active Comparator: Control group - ACLS
Advanced cardiovascular life support as described in the guidelines
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Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.
Time Frame: 60 minutes
|
Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.
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60 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.
Time Frame: 30 days
|
The mRs are dichotomised into good (score 0-3) and poor (score 4-6) neurological state.
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30 days
|
Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.
Time Frame: 15 minutes
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In the control group, EtCO2 is measured after airway management is completed.
In the intervention group, EtCO2 is measured after airway management is completed, before balloon inflation and 30, 60 and 90 seconds after balloon inflation.
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15 minutes
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Change in blood pressures after aortic occlusion
Time Frame: 15 minutes
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In the intervention group, intra-aortic blood pressure measurements from the REBOA catheter are recorded.
This applies only to the catheters with CE/FDA approval for invasive blood pressure measurements and will therefore be assessed in a sub-group of the participants.
Continuous registration of invasive blood pressure will start before aortic occlusion.
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15 minutes
|
Difference in left ventricular ejection fraction (LVEF) measured by echocardiography
Time Frame: 1-2 weeks
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Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group.
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1-2 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory outcome - All-cause mortality one year after randomization
Time Frame: One year
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Difference in all-cause mortality between the intervention and control group after one year.
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One year
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Exploratory outcome - Difference in renal function between intervention and control group
Time Frame: 30 days
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Values of serum creatinine (umol/L) and urine output (ml/kg/h) will be combined to classify renal function according to the Acute Kidney Injury Network (AKIN) classification, into stage 1-3.
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30 days
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Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group
Time Frame: 30 days
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Number of days renal replacement therapy is needed
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30 days
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Exploratory outcome - difference in the liver function (albumine) between intervention and control group
Time Frame: 30 days
|
Value of albumine (mg/L)
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30 days
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Exploratory outcome - difference in the liver function (ASAT/ALAT) between intervention and control group
Time Frame: 30 days
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Value of ASAT and ALAT (U/L)
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30 days
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Exploratory outcome - Incidents of all adverse events
Time Frame: 30 days
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assessment of all adverse events, both suspected and unsuspected, in both intervention and control group
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30 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rune Wiseth, md phd, St Olav's Hospital
Publications and helpful links
General Publications
- Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.
- Brede JR, Skulberg AK, Rehn M, Thorsen K, Klepstad P, Tylleskar I, Farbu B, Dale J, Nordseth T, Wiseth R, Kruger AJ. REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial. Trials. 2021 Jul 31;22(1):511. doi: 10.1186/s13063-021-05477-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1253-0322 (Registry Identifier: WHO Universal Trial Number UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Individual level data will be made available to sponsor institutions on the REBOARREST data space in HUNT Cloud. Access will be controlled by a data processor agreement between the partner and funder. Pseudonymous individual level data collected during the trial, will be made available on request to researchers from other scientific institutions by approval of the project management to ensure that usage is compliant with privacy and consent requirements as well as conditions for attribution and usage.
Data sharing with editors or peer-reviewers of scientific journals, conferences or the like will not require additional consent or data access agreement with sponsor, as such data will not be shared onward or used beyond reviewing this trial.
After data sharing, the sponsor must be acknowledged in any publication resulting from the shared data. For closer collaboration attribution based on the Vancouver Convention will apply.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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