Dataset Information

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

ABSTRACT:

Importance

Bleeding is the most common cause of preventable death after trauma.

Objective

To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.

Design, setting, and participants

Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days.

Intervention

Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44).

Main outcomes and measures

The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death.

Results

Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours.

Conclusions and relevance

In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone.

Trial registration

isrctn.org Identifier: ISRCTN16184981.

SUBMITTER: Jansen JO

PROVIDER: S-EPMC10570916 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Jansen Jan O JO Hudson Jemma J Cochran Claire C MacLennan Graeme G Lendrum Robbie R Sadek Sam S Gillies Katie K Cotton Seonaidh S Kennedy Charlotte C Boyers Dwayne D Ferry Gillian G Lawrie Louisa L Nath Mintu M Wileman Samantha S Forrest Mark M Brohi Karim K Harris Tim T Lecky Fiona F Moran Chris C Morrison Jonathan J JJ Norrie John J Paterson Alan A Tai Nigel N Welch Nick N Campbell Marion K MK Aylwin Chris C Bew Duncan D Brooks Adam A Chinery James J Cowlam Tom T Frith Dan D George Arun A Hudson Anthony A Johnstone Phillip P Mahmood Ansar A Novak Alex A O'Meara Matt M Reid Stuart S Sattout Abdo A Smith Chris C Stansfield Tim T Thompson Julian J

JAMA 20231101 19

<h4>Importance</h4>Bleeding is the most common cause of preventable death after trauma.<h4>Objective</h4>To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage.<h4>Design, setting, and participants</h4>Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients ...[more]

PMID: 37824132

Similar Datasets

Project description:ImportanceHemorrhage is the most common cause of preventable death after injury. Most deaths occur early, in the prehospital phase of care.ObjectiveTo establish whether prehospital zone 1 (supraceliac) partial resuscitative endovascular balloon occlusion of the aorta (Z1 P-REBOA) can be achieved in the resuscitation of adult trauma patients at risk of cardiac arrest and death due to exsanguination.Design, setting, and participantsThis was a prospective observational cohort study (Idea, Development, Exploration, Assessment and Long-term follow-up [IDEAL] 2A design) with recruitment from June 2020 to March 2022 and follow-up until discharge from hospital, death, or 90 days evaluating a physician-led and physician-delivered, urban prehospital trauma service in the Greater London area. Trauma patients aged 16 years and older with suspected exsanguinating subdiaphragmatic hemorrhage, recent or imminent hypovolemic traumatic cardiac arrest (TCA) were included. Those with unsurvivable injuries or who were pregnant were excluded. Of 2960 individuals attended by the service during the study period, 16 were included in the study.ExposuresZI REBOA or P-REBOA.Main outcomes and measuresThe main outcome was the proportion of patients in whom Z1 REBOA and Z1 P-REBOA were achieved. Clinical end points included systolic blood pressure (SBP) response to Z1 REBOA, mortality rate (1 hour, 3 hours, 24 hours, or 30 days postinjury), and survival to hospital discharge.ResultsFemoral arterial access for Z1 REBOA was attempted in 16 patients (median [range] age, 30 [17-76] years; 14 [81%] male; median [IQR] Injury Severity Score, 50 [39-57]). In 2 patients with successful arterial access, REBOA was not attempted due to improvement in clinical condition. In the other 14 patients (8 [57%] of whom were in traumatic cardiac arrest [TCA]), 11 successfully underwent cannulation and had aortic balloons inflated in Z1. The 3 individuals in whom cannulation was unsuccessful were in TCA (failure rate = 3/14 [21%]). Median (IQR) pre-REBOA SBP in the 11 individuals for whom cannulation was successful (5 [46%] in TCA) was 47 (33-52) mm Hg. Z1 REBOA plus P-REBOA was associated with a significant improvement in BP (median [IQR] SBP at emergency department arrival, 101 [77-107] mm Hg; 0 of 10 patients were in TCA at arrival). The median group-level improvement in SBP from the pre-REBOA value was 52 (95% CI, 42-77) mm Hg (P < .004). P-REBOA was feasible in 8 individuals (8/11 [73%]) and occurred spontaneously in 4 of these. The 1- and 3-hour postinjury mortality rate was 9% (1/11), 24-hour mortality was 27% (3/11), and 30-day mortality was 82% (9/11). Survival to hospital discharge was 18% (2/11). Both survivors underwent early Z1 P-REBOA.Conclusions and relevanceIn this study, prehospital Z1 P-REBOA is feasible and may enable early survival, but with a significant incidence of late death.Trial registrationClinicalTrials.gov Identifier: NCT04145271.

Project description:BackgroundMultiple studies regarding the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in patients with non-compressible torso injuries and uncontrolled haemorrhagic shock were recently published. To date, the clinical evidence of the efficacy of REBOA is still debated. We aimed to conduct a systematic review assessing the clinical efficacy and safety of REBOA in patients with major trauma and uncontrolled haemorrhagic shock.MethodsWe systematically searched MEDLINE (PubMed), EMBASE and CENTRAL up to June 2020. All randomized controlled trials and observational studies that investigated the use of REBOA compared to resuscitative thoracotomy (RT) with/without REBOA or no-REBOA were eligible. We followed the PRISMA and MOOSE guidelines. Two authors independently extracted data and appraised the risk of bias of included studies. Effect sizes were pooled in a meta-analysis using random-effects models. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Primary outcomes were mortality, volume of infused blood components, health-related quality of life, time to haemorrhage control and any adverse effects. Secondary outcomes were improvement in haemodynamic status and failure/success of REBOA technique.ResultsWe included 11 studies (5866 participants) ranging from fair to good quality. REBOA was associated with lower mortality when compared to RT (aOR 0.38; 95% CI 0.20-0.74), whereas no difference was observed when REBOA was compared to no-REBOA (aOR 1.40; 95% CI 0.79-2.46). No significant difference in health-related quality of life between REBOA and RT (p = 0.766). The most commonly reported complications were amputation, haematoma and pseudoaneurysm. Sparse data and heterogeneity of reporting for all other outcomes prevented any estimate.ConclusionsOur findings on overall mortality suggest a positive effect of REBOA among non-compressible torso injuries when compared to RT but no differences compared to no-REBOA. Variability in indications and patient characteristics prevents any conclusion deserving further investigation. REBOA should be promoted in specific training programs in an experimental setting in order to test its effectiveness and a randomized trial should be planned.

Project description:Background (rationale/purpose/objective)Resuscitative endovascular balloon occlusion of the aorta (REBOA) is used to temporary control non-compressible truncal hemorrhage (NCTH) as bridge to definitive surgical treatment. The dependence on radiography for safe balloon positioning is one factor that limits the extended use of REBOA in civilian and military pre-hospital settings. We aimed to determine standardized sex and age-based variable-distance catheter insertion lengths for accurate REBOA placement without initial fluoroscopic confirmation.MethodsContrast enhanced CT-scans from a representative sample of a Dutch non-trauma population were retrospectively analyzed. Intravascular distances were measured from the bilateral common femoral artery access points (FAAP) to the middle of the aortic occlusion zones and accompanying boundaries. Means and 95% confidence intervals for the distances from the FAAPs to the boundaries and mid-zone III were calculated for all (combined) sex and age-based subgroups. Optimal insertion lengths and potentially safe regions were determined for these groups. Bootstrap analysis was performed in combination with a 40-mm long balloon introduction simulation to determine error-rates and REBOA placement accuracy for the general population.ResultsIn total, 1354 non-trauma patients (694 females) were included. Vascular distances increased with age and were longer in males. The iliofemoral trajectory was 7 mm longer on the right side. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion lengths showed up to 30 mm difference, ranging between 234 and 264 mm. Statistically significant and potentially clinically relevant differences were observed between the anatomical distances and necessary introduction depths for each subgroup.ConclusionThis is the first study to compare aortic morphology and intravascular distances between combined sex and age-based subgroups. As zone III length was consistent, length variability and elongation seem to mainly originate in the iliofemoral trajectory and zone II. The optimal zone I catheter insertion length would be 430 mm. Optimal zone III catheter insertion ranged between 234 and 264 mm. These standardized variable-distance insertion lengths could facilitate safer fluoroscopy-free REBOA in austere, pre-hospital settings.

Project description:BackgroundOut-of-hospital cardiac arrest (OHCA) is a critical incident with a high mortality rate. Augmentation of the circulation during cardiopulmonary resuscitation (CPR) might be beneficial. Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) redistribute cardiac output to the organs proximal to the occlusion. Preclinical data support that patients in non-traumatic cardiac arrest might benefit from REBOA in the thoracic level during CPR. This study describes a training programme to implement the REBOA procedure to a prehospital working team, in preparation to a planned clinical study.MethodsWe developed a team-based REBOA training programme involving the physicians and paramedics working on the National Air Ambulance helicopter base in Trondheim, Norway. The programme consists of a four-step approach to educate, train and implement the REBOA procedure in a simulated prehospital setting. An objective structured assessment of prehospital REBOA application scoring chart and a special designed simulation mannequin was made for this study.ResultsSeven physicians and 3 paramedics participated. The time needed to perform the REBOA procedure was 8.5 (6.3-12.7) min. The corresponding time from arrival at scene to balloon inflation was 12.0 (8.8-15) min. The total objective assessment scores of the candidates' competency was 41.8 (39-43.5) points out of 48. The advanced cardiovascular life support (ACLS) remained at standard quality, regardless of the simultaneous REBOA procedure.ConclusionThis four-step approach to educate, train and implement the REBOA procedure to a prehospital working team ensures adequate competence in a simulated OHCA setting. The use of a structured training programme and objective assessment of skills is recommended before utilising the procedure in a clinical setting. In a simulated setting, the procedure does not add significant time to the prehospital resuscitation time nor does the procedure interfere with the quality of the ACLS.Trial registration numberNCT03534011.

Project description:BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) may be an adjunct treatment to cardiopulmonary resuscitation (CPR). Aortic occlusion may increase aortic pressure and increase the coronary perfusion pressure and the cerebral blood flow. Peripheral arterial blood pressure is often measured during or after CPR, however, changes in peripheral blood pressure after aortic occlusion is insufficiently described. This study aimed to assess changes in peripheral arterial blood pressure after REBOA in patients with out of hospital cardiac arrest.MethodsA prospective observational study performed at the helicopter emergency medical service in Trondheim (Norway). Eligible patients received REBOA as adjunct treatment to advanced cardiac life support. Peripheral invasive arterial blood pressure and end-tidal CO2 (EtCO2) was measured before and after aortic occlusion. Differences in arterial blood pressures and EtCO2 before and after occlusion was analysed with Wilcoxon Signed Rank test.ResultsFive patients were included to the study. The median REBOA procedural time was 11 min and median time from dispatch to aortic occlusion was 50 min. Two patients achieved return of spontaneous circulation. EtCO2 increased significantly 60 s after occlusion, by a mean of 1.16 kPa (p = 0.043). Before occlusion the arterial pressure in the compression phase were 43.2 (range 12-112) mmHg, the mean pressure 18.6 (range 4-27) mmHg and pressure in the relaxation phase 7.8 (range - 7 - 22) mmHg. After aortic occlusion the corresponding pressures were 114.8 (range 23-241) mmHg, 44.6 (range 15-87) mmHg and 14.8 (range 0-29) mmHg. The arterial pressures were significant different in the compression phase and as mean pressure (p = 0.043 and p = 0.043, respectively) and not significant in the relaxation phase (p = 0.223).ConclusionThis study is, to our knowledge, the first to assess the peripheral invasive arterial blood pressure response to aortic occlusion during CPR in the pre-hospital setting. REBOA application during CPR is associated with a significantly increase in peripheral artery pressures. This likely indicates improved central aortic blood pressure and warrants studies with simultaneous peripheral and central blood pressure measurement during aortic occlusion.Trial registrationThe study is registered in ClinicalTrials.gov ( NCT03534011 ).

Project description:BackgroundIn this review, we assess the state of Resuscitative Endovascular Occlusion of the Aorta (REBOA) today with respect to out-of-hospital (OOH) vs. inhospital (H) use in blunt and penetrating trauma, as well as discuss areas of promising research that may be key in further advancement of REBOA applications.MethodsTo analyze the trends in REBOA use, we conducted a review of the literature and identified articles with human or animal data that fit the respective inclusion and exclusion criteria. In separate tables, we compiled data extracted from selected articles in categories including injury type, zone and duration of REBOA, setting in which REBOA was performed, sample size, age, sex and outcome. Based on these tables as well as more detailed review of some key cases of REBOA usage, we assessed the current state of REBOA as well as coagulation and histological disturbances associated with its usage. All statistical tests were 2-sided using an alpha=0.05 for significance. Analysis was done using SAS 9.5 (Cary, NC). Tests for significance was done with a t-test for continuous data and a Chi Square Test for categorical data.ResultsIn a total of 44 cases performed outside of a hospital in both military and civilian settings, the overall survival was found to be 88.6%, significantly higher than the 50.4% survival calculated from 1,807 cases of REBOA performed within a hospital (p<.0001). We observe from human data a propensity to use Zone I in penetrating trauma and Zone III in blunt injuries. We observe lower final metabolic markers in animal studies with shorter REBOA time and longer follow-up times.ConclusionsFurther research related to human use of REBOA must be focused on earlier initiation of REBOA after injury which may depend on development of rapid vascular access devices and techniques more so than on any new improvements in REBOA. Future animal studies should provide detailed multisystem organ assessment to accurately define organ injury and metabolic burden associated with REBOA application. Overall, animal studies must involve realistic models of injury with severe clinical scenarios approximating human trauma and exsanguination, especially with long-term follow-up after injury.

Dataset Information

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Similar Datasets

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