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NCT Number: NCT04596514

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Base, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

REBOA

Procedure

Resuscitative endovascular balloon occlusion of the aorta (REBOA)

usual procedure according to guidelines

Procedure

Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.

    Time frame: 15 minutes

    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.

  3. Change in blood pressures after aortic occlusion

    Time frame: 15 minutes

    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.

  4. Difference in left ventricular ejection fraction (LVEF) measured by echocardiography

    Time frame: 1-2 weeks

    Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group.

Other outcomes

  1. Exploratory outcome - All-cause mortality one year after randomization

    Time frame: One year

    Difference in all-cause mortality between the intervention and control group after one year.

  2. Exploratory outcome - Difference in renal function between intervention and control group

    Time frame: 30 days

    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.

  3. Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group

    Time frame: 30 days

    Number of days renal replacement therapy is needed

  4. Exploratory outcome - difference in the liver function (albumine) between intervention and control group

    Time frame: 30 days

    Value of albumine (mg/L)

  5. Exploratory outcome - difference in the liver function (ASAT/ALAT) between intervention and control group

    Time frame: 30 days

    Value of ASAT and ALAT (U/L)

  6. Exploratory outcome - Incidents of all adverse events

    Time frame: 30 days

    assessment of all adverse events, both suspected and unsuspected, in both intervention and control group

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian Air Ambulance Foundation

Registry information

Official study title

A Randomised Trial on Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

Acronym: REBOARREST

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Oct 22, 2020
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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