- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
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
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Simon Sommerhuber, MD
- 전화번호: 004346353826109
- 이메일: simon.sommerhuber@kabeg.at
연구 장소
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Carinthia
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Klagenfurt, Carinthia, 오스트리아, 9020
- Klinikum Klagenfurt Am Worthersee
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연락하다:
- Simon Sommerhuber, MD
- 전화번호: 004346353826109
- 이메일: simon.sommerhuber@kabeg.at
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
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
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 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Time from initiation of AAJT application to complete inflation
기간: 1 hour
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1 hour
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Time from dispatch to application
기간: 1 hour
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1 hour
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time from arrival on scene to application
기간: 1 hour
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1 hour
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time from initiation of resuscitation to application
기간: 1 hour
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1 hour
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change in end-tidal CO₂ (etCO₂) measured in mmHg
기간: 1 hour
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1 hour
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measured change in arterial pressures (systolic/diastolic/mean arterial pressure)
기간: 1 hour
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1 hour
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any ROSC rate
기간: 24 hours
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24 hours
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sustained ROSC rate
기간: 24 hours
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24 hours
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- S2026-04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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