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

2026년 4월 30일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

5

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Carinthia
      • Klagenfurt, Carinthia, 오스트리아, 9020
        • Klinikum Klagenfurt Am Worthersee
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Time from initiation of AAJT application to complete inflation
기간: 1 hour
1 hour

2차 결과 측정

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

기타 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 30 days
Analysis of the autopsy-report with regards to findings of device related intrathoracic or intraabdominal injuries
30 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 7월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 30일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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