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Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest

Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573566
Acronym
ATTICA
Enrollment
5
Registered
2026-05-07
Start date
2026-08-01
Completion date
2027-09-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asystole, Cardiac Arrest (CA), Out-of-hospital Cardiac Arrest (OHCA), Pulseless Electrical Activity, Ventricular Fibrillation

Keywords

AAJT, OHCA, Aortic occlusion

Brief summary

The aim of the study is to investigate whether occluding the abdominal aorta with an external device could be a potential therapeutic option in cases of non-traumatic cardiac arrest occurring outside of a hospital. In cardiac arrest, the heart suddenly stops beating, causing the circulation of blood to collapse. In this situation, vital organs-especially the brain and the heart itself-are no longer adequately supplied with oxygen. Without immediate treatment, severe damage or death occurs within minutes. The study therefore examines a specific intervention: the temporary occlusion of the abdominal aorta, which carries blood to the lower regions of the body. If this artery is blocked for a short period, the available blood can be redirected more effectively to the upper parts of the body. In theory, this could improve the oxygen supply to these organs and increase the likelihood that the heart will resume beating or that neurological damage can be reduced.

Detailed description

Background There is now a substantial body of experimental and clinical research on resuscitative endovascular balloon occlusion of the aorta (REBOA), highlighting its potential role in resuscitation medicine. As early as 1993, a porcine model was used for the first time to investigate the effect of REBOA on the quality of cardiopulmonary resuscitation. In this study on anesthetized pigs, temporary occlusion of the aorta during cardiopulmonary Resuscitation (CPR) resulted in a significant improvement in central hemodynamic parameters, particularly an increase in coronary perfusion pressure. Initial case series from the past 10 years have also examined the use of REBOA in non-traumatic cardiac arrest. Despite overall small sample sizes, they demonstrated significant increases in end-tidal CO₂ (etCO₂) as well as higher rates of any ROSC. A common feature of both studies was the relatively long interval from emergency call to REBOA application, exceeding 45 minutes in each. More recent studies from the past five years have confirmed these conclusions: REBOA placement led to improvements in various resuscitation indices. However, the procedure is often technically challenging, and when performed in-hospital, it typically took place more than 45 minutes after the initial emergency call. Two of the centers involved in these studies have now started to recruit for randomized controlled trials with more than 200 patients. As an alternative to REBOA placement in Zone 3 for hemodynamically unstable patients in hemorrhagic shock due to pelvic or lower extremity injuries, the Abdominal Aortic Junctional Tourniquet (AAJT) is available. The first publication appeared in 2009, and market approval in the United States was granted in 2013. The device applies external pressure on the abdomen via balloon inflation under a abdominal binder with the goal of occluding flow in the abdominal aorta. For non-traumatic cardiac arrest, there is currently only one animal study involving six pigs. In this study, AAJT application improved blood flow and diastolic pressure in the carotid artery, but did not confer a survival benefit. During resuscitation, a diastolic blood pressure of over 30 mmHg should be achieved. This was reaffirmed in the latest European Resuscitation Council (ERC) guidelines of 2025, as it is associated with an increased rate of survival to hospital discharge. Case series describing the application of the AAJT in traumatic cardiac arrest have demonstrated a notably high rate of favorable physiological responses. Reported positive outcomes include a change from non-perfusing or disorganized rhythms to more organized cardiac rhythms, an increase in end-tidal carbon dioxide (etCO₂) as a surrogate marker of improved circulation and perfusion, and, in several cases, the achievement of return of spontaneous circulation (ROSC). These findings suggest that temporary aortic occlusion using the AAJT may improve central blood flow and augment coronary as well as cerebral perfusion during resuscitation efforts. Rationale The aortic occlusion during medical cardiac arrest with REBOA has shown promising results, but time-to-occlusion often requires a significant amount of time, with a high failure rate. The aortic occlusion with the AAJT device is a faster and non-invasive approach to the same problem. This study aims to show the feasibility of this rationale in a limited amount of patients.

Interventions

DEVICEAbdominal Aortic Junction Tourniquet in non-traumatic out-of-hospital cardiac arrest

If a patient is found in cardiac arrest, eligibility is assessed. If the patient is deemed eligible, the following steps are performed: 1. Initiation of standard Advanced Cardiac Life Support (ACLS) 2. Endotracheal intubation and controlled mandatory ventilation according to ERC 2025 guidelines 3. Initiation of mechanical CPR 4. Arterial cannulation of an artery in the left upper extremity; access via the right upper extremity may be attempted after two unsuccessful attempts 5. Exclusion of reversible causes based on clinical history, physical examination, and/or ultrasound 6. Inflation of the AAJT 7. Device removal and termination of resuscitation (TOR) if ERC criteria are met 8. If return of spontaneous circulation (ROSC) is achieved, the AAJT remains in place until normotension is established, either spontaneously or with vasopressor support

Sponsors

Klinikum Klagenfurt am Wörthersee
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Cardiac arrest with indication for initiation of resuscitation * Age ≥ 18 years

Exclusion criteria

* Pregnancy (suspected or confirmed) * Age \< 18 years * Abdominal circumference does not allow application of the AAJT * Traumatic etiology * Planned eCPR or other intervention in which study inclusion would delay the standard of care * Known abdominal aortic aneurysm

Design outcomes

Primary

MeasureTime frame
Time from initiation of AAJT application to complete inflation1 hour

Secondary

MeasureTime frame
Time from dispatch to application1 hour
time from arrival on scene to application1 hour
time from initiation of resuscitation to application1 hour
change in end-tidal CO₂ (etCO₂) measured in mmHg1 hour
measured change in arterial pressures (systolic/diastolic/mean arterial pressure)1 hour
any ROSC rate24 hours
sustained ROSC rate24 hours

Countries

Austria

Contacts

CONTACTSimon Sommerhuber, MD
simon.sommerhuber@kabeg.at004346353826109

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026