- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07573566
Abdominal Aortic Tourniquet Application for Non-Traumatic Out-of-Hospital Cardiac Arrest (ATTICA)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Simon Sommerhuber, MD
- Telefonní číslo: 004346353826109
- E-mail: simon.sommerhuber@kabeg.at
Studijní místa
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Carinthia
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Klagenfurt, Carinthia, Rakousko, 9020
- Klinikum Klagenfurt Am Worthersee
-
Kontakt:
- Simon Sommerhuber, MD
- Telefonní číslo: 004346353826109
- E-mail: simon.sommerhuber@kabeg.at
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Abdominal aortic occlusion by AAJT Application
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If a patient is found in cardiac arrest, eligibility is assessed. If the patient is deemed eligible, the following steps are performed:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Time from initiation of AAJT application to complete inflation
Časové okno: 1 hour
|
1 hour
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Time from dispatch to application
Časové okno: 1 hour
|
1 hour
|
|
time from arrival on scene to application
Časové okno: 1 hour
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1 hour
|
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time from initiation of resuscitation to application
Časové okno: 1 hour
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1 hour
|
|
change in end-tidal CO₂ (etCO₂) measured in mmHg
Časové okno: 1 hour
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1 hour
|
|
measured change in arterial pressures (systolic/diastolic/mean arterial pressure)
Časové okno: 1 hour
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1 hour
|
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any ROSC rate
Časové okno: 24 hours
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24 hours
|
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sustained ROSC rate
Časové okno: 24 hours
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24 hours
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 30 days
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Analysis of the CT-report with regards to findings of device related intrathoracic or intraabdominal injuries
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30 days
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In patients without ROSC in whom an autopsy was performed: percentage of patients with intrathoracic injuries; percentage of patients with intra-abdominal injuries
Časové okno: 30 days
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Analysis of the autopsy-report with regards to findings of device related intrathoracic or intraabdominal injuries
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30 days
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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Jang DH, Lee DK, Jo YH, Park SM, Oh YT, Im CW. Resuscitative endovascular occlusion of the aorta (REBOA) as a mechanical method for increasing the coronary perfusion pressure in non-traumatic out-of-hospital cardiac arrest patients. Resuscitation. 2022 Oct;179:277-284. doi: 10.1016/j.resuscitation.2022.07.020. Epub 2022 Jul 21.
- Levis A, Greif R, Hautz WE, Lehmann LE, Hunziker L, Fehr T, Haenggi M. Resuscitative endovascular balloon occlusion of the aorta (REBOA) during cardiopulmonary resuscitation: A pilot study. Resuscitation. 2020 Nov;156:27-34. doi: 10.1016/j.resuscitation.2020.08.118. Epub 2020 Aug 29.
- Kim HE, Chu SE, Jo YH, Chiang WC, Jang DH, Chang CH, Oh SH, Chen HA, Park SM, Sun JT, Lee DK. Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial. Trials. 2024 Feb 13;25(1):118. doi: 10.1186/s13063-024-07928-x.
- 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.
- Poliakova Y, Oshovskyy V. Temporary aortic occlusion with the abdominal tourniquet for refractory postpartum hemorrhage: A proof-of-concept study in a war-affected region. Int J Gynaecol Obstet. 2026 Jan;172(1):582-587. doi: 10.1002/ijgo.70395. Epub 2025 Jul 18.
- Androshchuk D, Verba A. Successful Management of Battlefield Traumatic Cardiac Arrest Using the Abdominal Aortic and Junctional Tourniquet (AAJT): A Case Series. J Spec Oper Med. 2025 Apr 4;25(1):65-69. doi: 10.55460/7FEV-3ZRK.
- Balian F, Garner AA, Weatherall A, Lee A. First experience with the abdominal aortic and junctional tourniquet in prehospital traumatic cardiac arrest. Resuscitation. 2020 Nov;156:210-214. doi: 10.1016/j.resuscitation.2020.09.018. Epub 2020 Sep 23.
- Hewitt CW, Pombo MA, Blough PE, Castaneda MG, Percival TJ, Rall JM. Effect of the Abdominal Aortic and Junctional Tourniquet on chest compressions in a swine model of ventricular fibrillation. Am J Emerg Med. 2021 Jul;45:297-302. doi: 10.1016/j.ajem.2020.08.075. Epub 2020 Aug 27.
- Smith TN, Beaven A, Handford C, Sellon E, Parker PJ. Abdominal Aortic Junctional Tourniquet - Stabilized (AAJTS) can be applied both successfully and rapidly by Combat Medical Technicians (CMTs). BMJ Mil Health. 2023 Nov 22;169(6):493-498. doi: 10.1136/bmjmilitary-2021-001881.
- Daley J, Buckley R, Kisken KC, Barber D, Ayyagari R, Wira C, Aydin A, Latich I, Lozada JCP, Joseph D, Marino A, Mojibian H, Pollak J, Chaar CO, Bonz J, Belsky J, Coughlin R, Liu R, Sather J, Van Tonder R, Beekman R, Fults E, Johnson A, Moore C. Emergency department initiated resuscitative endovascular balloon occlusion of the aorta (REBOA) for out-of-hospital cardiac arrest is feasible and associated with improvements in end-tidal carbon dioxide. J Am Coll Emerg Physicians Open. 2022 Sep 10;3(5):e12791. doi: 10.1002/emp2.12791. eCollection 2022 Oct.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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