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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-0322 | Registry Identifier | WHO Universal Trial Number UTN |
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| Name | Class |
|---|---|
| Norwegian Air Ambulance Foundation | OTHER |
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The primary aim of this trial is to assess the efficacy of resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct treatment to advanced cardiovascular life support (ACLS) in patients with out-of-hospital cardiac arrest.
Out of hospital cardiac arrest (OHCA) carries a high mortality rate. The treatment of out-of-hospital cardiac arrest is ACLS as stated in the guidelines from the Norwegian Resuscitation Council and the European Resuscitation Guidelines.
Recently, REBOA has been proposed as an adjunct treatment in management of non-traumatic cardiac arrest patients, because thoracic aortic occlusion provides a redistribution of the cardiac output to organs proximal to the occlusion. Preclinical studies demonstrate that REBOA during CPR provide both increased coronary artery blood flow and perfusion pressure and increased rates of return of spontaneous circulation (ROSC).
This is the first prospective trial in the world to assess the efficacy of REBOA in non-traumatic cardiac arrest. The intervention is shown feasible in the pre-hospital setting. If this trial provides a signal of benefit in patients, this study could initiate further clinical research which could change current resuscitation practice world-wide.
This is a prospective, randomised, parallel group, multi-centre, phase II clinical trial.
Patients are randomised in a 1:1 ratio to be included to the control group or the intervention group. The control group receives ACLS according to national guidelines, while the intervention group receives ACLS according to national guidelines and the REBOA procedure as an adjunct treatment.
The REBOA procedure is performed by a team consisting of a physician (anesteshiologist) and a paramedic, working at a helicopter emergency medical service (HEMS) base. All operators will be properly educated and tested before they can include patients.
If the patients in the intervention group achieves ROSC, the balloon will be deflated and post-ROSC treatment will be continued as per routine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group - REBOA | Experimental | Resuscitative Balloon Occlusion of the Aorta after advanced cardiac life support if return of spontaneous circulation is not achieved |
|
| Control group - ACLS | Active Comparator | Advanced cardiovascular life support as described in the guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REBOA | Procedure | Resuscitative endovascular balloon occlusion of the aorta (REBOA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that achieve return of spontaneous circulation (ROSC) with a duration of at least 20 minutes. | Sustained ROSC means return of spontaneous circulation with a duration of at least 20 minutes. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients surviving to 30 days with good neurologic status, defined as a modified Rankin scale (mRS) score 0-3. | The mRs are dichotomised into good (score 0-3) and poor (score 4-6) neurological state. | 30 days |
| Difference in end-tidal CO2 (EtCO2) measurements between control group and intervention group after aortic occlusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory outcome - All-cause mortality one year after randomization | Difference in all-cause mortality between the intervention and control group after one year. | One year |
| Exploratory outcome - Difference in renal function between intervention and control group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rune Wiseth, MD, PhD | St Olav's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Base | Aarhus | Denmark | ||||
| Billund HEMS-base |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31707942 | 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. | |
| 42087223 | Derived |
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The full study protocol, statistical analysis plan, information letter for consent and other trial documents will be published open access. The clinical study report and statistical analysis report will also be made openly available but may be altered to hide information that may lead to identification of individual study participants. These documents will be shared at HUNT Cloud.
Study protocol and ICF will be available before study start. SAP will be available before first interim analysis.
Individual level data will be made available to sponsor institutions on the REBOARREST data space in HUNT Cloud. Access will be controlled by a data processor agreement between the partner and funder. Pseudonymous individual level data collected during the trial, will be made available on request to researchers from other scientific institutions by approval of the project management to ensure that usage is compliant with privacy and consent requirements as well as conditions for attribution and usage.
Data sharing with editors or peer-reviewers of scientific journals, conferences or the like will not require additional consent or data access agreement with sponsor, as such data will not be shared onward or used beyond reviewing this trial.
After data sharing, the sponsor must be acknowledged in any publication resulting from the shared data. For closer collaboration attribution based on the Vancouver Convention will apply.
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Blinded from the statisticians who carry out analyses
| usual procedure according to guidelines | Procedure | Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines |
|
In the control group, EtCO2 is measured after airway management is completed. In the intervention group, EtCO2 is measured after airway management is completed, before balloon inflation and 30, 60 and 90 seconds after balloon inflation. |
| 15 minutes |
| Change in blood pressures after aortic occlusion | In the intervention group, intra-aortic blood pressure measurements from the REBOA catheter are recorded. This applies only to the catheters with CE/FDA approval for invasive blood pressure measurements and will therefore be assessed in a sub-group of the participants. Continuous registration of invasive blood pressure will start before aortic occlusion. | 15 minutes |
| Difference in left ventricular ejection fraction (LVEF) measured by echocardiography | Echocardiography after admission, after a few days-up to one week and at discharge will be assessed - both from the control and intervention group. | 1-2 weeks |
Values of serum creatinine (umol/L) and urine output (ml/kg/h) will be combined to classify renal function according to the Acute Kidney Injury Network (AKIN) classification, into stage 1-3. |
| 30 days |
| Exploratory outcome - difference in the need for renal replacement therapy between intervention and control group | Number of days renal replacement therapy is needed | 30 days |
| Exploratory outcome - difference in the liver function (albumine) between intervention and control group | Value of albumine (mg/L) | 30 days |
| Exploratory outcome - difference in the liver function (ASAT/ALAT) between intervention and control group | Value of ASAT and ALAT (U/L) | 30 days |
| Exploratory outcome - Incidents of all adverse events | assessment of all adverse events, both suspected and unsuspected, in both intervention and control group | 30 days |
| Billund |
| Denmark |
| Ringsted HEMS-base | Ringsted | Denmark |
| Skive HEMS | Skive | Denmark |
| Maggiore Hospital | Bologna | Italy |
| Haukeland University Hospital | Bergen | Norway |
| Drammen Hospital | Drammen | Norway |
| Lørenskog HEMS Unit | Oslo | Norway |
| Rapid response car - 119 Oslo | Oslo | Norway |
| Stavanger University Hospital | Stavanger | 4068 | Norway |
| St Olavs Hospital | Trondheim | 7030 | Norway |
| Brede JR, Farbu BH, Gamberini L, Thorsen K, Rehn M, Rognas L, Tonsager K, Sunde GA, Lauritzen M, Lupi C, Tartaglione M, Skjaerseth EA, Aaen M, Wiseth R, Kruger AJ. Prehospital resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest (REBOARREST): an international, multicentre, open label, pragmatic, randomised, controlled trial. Crit Care. 2026 May 5;30(1):324. doi: 10.1186/s13054-026-06057-y. |
| 34332617 | Derived | 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. |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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