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

30. april 2026 oppdatert av: Markus Koestenberger, Klinikum Klagenfurt am Wörthersee

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

5

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Carinthia
      • Klagenfurt, Carinthia, Østerrike, 9020
        • Klinikum Klagenfurt Am Worthersee
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Abdominal aortic occlusion by AAJT Application

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time from initiation of AAJT application to complete inflation
Tidsramme: 1 hour
1 hour

Sekundære resultatmål

Resultatmål
Tidsramme
Time from dispatch to application
Tidsramme: 1 hour
1 hour
time from arrival on scene to application
Tidsramme: 1 hour
1 hour
time from initiation of resuscitation to application
Tidsramme: 1 hour
1 hour
change in end-tidal CO₂ (etCO₂) measured in mmHg
Tidsramme: 1 hour
1 hour
measured change in arterial pressures (systolic/diastolic/mean arterial pressure)
Tidsramme: 1 hour
1 hour
any ROSC rate
Tidsramme: 24 hours
24 hours
sustained ROSC rate
Tidsramme: 24 hours
24 hours

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
In patients admitted to the hospital with ROSC who underwent CT of the thorax and abdomen: percentage of patients with intrathoracic injuries; percentage of patients with intra-abdominal injuries
Tidsramme: 30 days
Analysis of the CT-report with regards to findings of device related intrathoracic or intraabdominal injuries
30 days
In patients without ROSC in whom an autopsy was performed: percentage of patients with intrathoracic injuries; percentage of patients with intra-abdominal injuries
Tidsramme: 30 days
Analysis of the autopsy-report with regards to findings of device related intrathoracic or intraabdominal injuries
30 days

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Due to the low number of included patients there are concerns regarding privacy.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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