Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out of Hospital Cardiac Arrest

NCT06071910 | Recruiting FDA Device

• 1 other identifier: 296654
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the feasibility of performing pre-hospital resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct to conventional Advanced Life Support (ALS) in patients suffering from non-traumatic out of hospital cardiac arrest (OHCA). As well as providing valuable insights into the technical feasibility of performing this procedure as part of a resuscitation attempt, the study will also document the beneficial physiological effects of REBOA in this group of patients.

Conditions

Cardiac Arrest; Cardiac Arrhythmia; Ventricular Fibrillation; Ventricular Arrythmia; Pulseless Electrical Activity; Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

• Device delivery

  The proportion of patients where Pre-Hospital Zone 1 REBOA for OHCA is achieved, with balloon inserted to 35 - 55 cm, proximal arterial blood pressure transduced and evidence of loss of distal invasive blood pressure trace during CPR confirming aortic occlusion.

  Within 1 hour of initiation

• Procedural timings

  Time taken to achieve REBOA for OHCA in mins * Time taken from start of the procedure (arterial catheterization) to balloon inflation in mins * Total duration of REBOA (inflation to final deflation) in mins * Time from arrival at scene to REBOA (balloon inflation) in mins * Time from 999 call to REBOA (balloon inflation) in mins

  Within 1 hour of initiation

Secondary Outcomes (3)

• Haemodynamic and oxygenation responses

  Within 1 hour of initiation

• Near Infra-Red Spectrometry

  Within 1 hour of initiation

• End Tidal CO2

  Within 1 hour of initiation

Study Arms (1)

Aortic balloon occulsion

OTHER

Delivery of ER-REBOA catheter to achieve aortic occlusion during resuscitation for out of hospital cardiac arrest, refractory to conventional advanced life support

Device: ER-REBOA catheter

Interventions

ER-REBOA catheter DEVICE

To achieve rapid aortic occlusion

Also known as: Aortic balloon occlusion, REBOA

Aortic balloon occulsion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Traumatic OHCA in patients within the East of England area AND with a East Anglian Air Ambulance (EAAA) REBOA team in attendance
• Patients below or equal to 80yrs of age and above or equal to 18yrs of age, according to available information/estimate at scene
• No flow \<10 mins from data available (i.e. total period in OHCA with no CPR)
• In cardiac arrest (with no sustained ROSC) on arrival of the EAAA REBOA team

You may not qualify if:

• Patients aged less than 18 or above 80 years
• Known terminal illness
• Multiple severe co-morbidities
• Traumatic Cardiac Arrest (TCA)
• Inability to deploy mechanical CPR (e.g. LUCAS Device)
• Pregnancy, obvious or suspected

Sponsors & Collaborators

• Queen Mary University of London: lead
• East Anglian Air Ambulance: collaborator
• Rosetrees Trust: collaborator
• The Dowager Countess Eleanor Peel Trust: collaborator
• The Drummond Foundation: collaborator

Study Sites (1)

East Anglian Air Ambulance

Norwich, NR6 6EG, United Kingdom

RECRUITING

Related Publications (16)

• Moriwaki Y, Tahara Y, Kosuge T, Suzuki N. Etiology of out-of-hospital cardiac arrest diagnosed via detailed examinations including perimortem computed tomography. J Emerg Trauma Shock. 2013 Apr;6(2):87-94. doi: 10.4103/0974-2700.110752.

  PMID: 23723616 BACKGROUND

• Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.

  PMID: 33197396 BACKGROUND

• Osborn LA, Brenner ML, Prater SJ, Moore LJ. Resuscitative endovascular balloon occlusion of the aorta: current evidence. Open Access Emerg Med. 2019 Jan 14;11:29-38. doi: 10.2147/OAEM.S166087. eCollection 2019.

  PMID: 30666171 BACKGROUND

• Lendrum R, Perkins Z, Chana M, Marsden M, Davenport R, Grier G, Sadek S, Davies G. Pre-hospital Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for exsanguinating pelvic haemorrhage. Resuscitation. 2019 Feb;135:6-13. doi: 10.1016/j.resuscitation.2018.12.018. Epub 2018 Dec 27.

  PMID: 30594600 BACKGROUND

• 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.

  PMID: 32866549 BACKGROUND

• Tang W, Weil MH, Noc M, Sun S, Gazmuri RJ, Bisera J. Augmented efficacy of external CPR by intermittent occlusion of the ascending aorta. Circulation. 1993 Oct;88(4 Pt 1):1916-21. doi: 10.1161/01.cir.88.4.1916.

  PMID: 8403337 BACKGROUND

• Manning JE, Murphy CA Jr, Hertz CM, Perretta SG, Mueller RA, Norfleet EA. Selective aortic arch perfusion during cardiac arrest: a new resuscitation technique. Ann Emerg Med. 1992 Sep;21(9):1058-65. doi: 10.1016/s0196-0644(05)80645-6.

  PMID: 1514716 BACKGROUND

• Gedeborg R, Rubertsson S, Wiklund L. Improved haemodynamics and restoration of spontaneous circulation with constant aortic occlusion during experimental cardiopulmonary resuscitation. Resuscitation. 1999 Apr-May;40(3):171-80. doi: 10.1016/s0300-9572(99)00021-0.

  PMID: 10395400 BACKGROUND

• Sesma J, Labandeira J, Sara MJ, Espila JL, Arteche A, Saez MJ. Effect of intra-aortic occlusion balloon in external thoracic compressions during CPR in pigs. Am J Emerg Med. 2002 Sep;20(5):453-62. doi: 10.1053/ajem.2002.32627.

  PMID: 12216044 BACKGROUND

• Hutin A, Levy Y, Lidouren F, Kohlhauer M, Carli P, Ghaleh B, Lamhaut L, Tissier R. Resuscitative endovascular balloon occlusion of the aorta vs epinephrine in the treatment of non-traumatic cardiac arrest in swine. Ann Intensive Care. 2021 May 17;11(1):81. doi: 10.1186/s13613-021-00871-z.

  PMID: 34002305 BACKGROUND

• Deakin CD, Barron DJ. Haemodynamic effects of descending aortic occlusion during cardiopulmonary resuscitation. Resuscitation. 1996 Nov;33(1):49-52. doi: 10.1016/s0300-9572(96)00992-6.

  PMID: 8959773 BACKGROUND

• Aslanger E, Golcuk E, Oflaz H, Yilmaz A, Mercanoglu F, Bugra Z, Umman B, Nisanci Y. Intraaortic balloon occlusion during refractory cardiac arrest. A case report. Resuscitation. 2009 Feb;80(2):281-3. doi: 10.1016/j.resuscitation.2008.10.017. Epub 2008 Dec 6.

  PMID: 19058900 BACKGROUND

• Kalogeropoulos AS, Kennon S, Karamasis GV, Smith EJ, Rees P. Successful Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction During Resuscitation From Cardiac Arrest by Combined Mechanical Chest Compressions and Intra-aortic Balloon Pump Counterpulsation: A Case Report. A A Pract. 2018 Jun 15;10(12):323-326. doi: 10.1213/XAA.0000000000000707.

  PMID: 29634573 BACKGROUND

• Gamberini L, Coniglio C, Lupi C, Tartaglione M, Mazzoli CA, Baldazzi M, Cecchi A, Ferri E, Chiarini V, Semeraro F, Gordini G; collaborators. Resuscitative endovascular occlusion of the aorta (REBOA) for refractory out of hospital cardiac arrest. An Utstein-based case series. Resuscitation. 2021 Aug;165:161-169. doi: 10.1016/j.resuscitation.2021.05.019. Epub 2021 Jun 3.

  PMID: 34089774 BACKGROUND

• Brede JR, Lafrenz T, Klepstad P, Skjaerseth EA, Nordseth T, Sovik E, Kruger AJ. Feasibility of Pre-Hospital Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest. J Am Heart Assoc. 2019 Nov 19;8(22):e014394. doi: 10.1161/JAHA.119.014394. Epub 2019 Nov 11.

  PMID: 31707942 BACKGROUND

• Aziz S, Barratt J, Wilson-Baig N, Lachowycz K, Major R, Barnard EBG, Rees P. A protocol for the ERICA-ARREST feasibility study of Emergency Resuscitative Endovascular Balloon occlusion of the Aorta in Out-of-Hospital Cardiac Arrest. Resusc Plus. 2024 Jun 13;19:100688. doi: 10.1016/j.resplu.2024.100688. eCollection 2024 Sep.

  PMID: 38974930 DERIVED

Related Links

• Consensus Paper on Out-of-Hospital Cardiac Arrest in England
• Department of Health Cardiovascular Disease Team. Cardiovascular Disease Outcomes Strategy- Improving outcomes for people with or at risk of cardiovascular disease

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest; Arrhythmias, Cardiac; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paul Rees, MD(Res)

CONTACT

07976 406496; paul.rees@eaaa.org.uk

Kate Lachowycz, PhD

CONTACT

07984 074 523; kate.lachowycz@eaaa.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential patients with OHCA in air ambulance operational area

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: October 10, 2023
• Study Start: June 4, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)