Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-traumatic Out of Hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— REBOARREST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596514
• Other study ID #: U1111-1253-0322
• Secondary ID: U1111-1253-0322
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: June 2025

Study information

• Verified date: July 2023
• Source: St. Olavs Hospital
• Contact: Andreas Jørstad Krüger, md phd
• Phone: +47 908 62 586
• Email: Andreas.kruger[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• REBOA
Resuscitative endovascular balloon occlusion of the aorta (REBOA)
• usual procedure according to guidelines
Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian Air Ambulance Foundation

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome - All-cause mortality one year after randomization	Difference in all-cause mortality between the intervention and control group after one year.	One year
Other	Exploratory outcome - Difference in renal function between intervention and control group	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.	30 days
Other	Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group	Number of days renal replacement therapy is needed	30 days
Other	Exploratory outcome - difference in the liver function (albumine) between intervention and control group	Value of albumine (mg/L)	30 days
Other	Exploratory outcome - difference in the liver function (ASAT/ALAT) between intervention and control group	Value of ASAT and ALAT (U/L)	30 days
Other	Exploratory outcome - Incidents of all adverse events	assessment of all adverse events, both suspected and unsuspected, in both intervention and control group	30 days
Primary	Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes.	Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes.	60 minutes
Secondary	The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3.	The mRs are dichotomised into good (score 0-3) and poor (score 4-6) neurological state.	30 days
Secondary	Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion.	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.	15 minutes
Secondary	Change in blood pressures after aortic occlusion	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.	15 minutes
Secondary	Difference in left ventricular ejection fraction (LVEF) measured by echocardiography	Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group.	1-2 weeks