Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for the treatment of trauma patients in distress from torso hemorrhage; a prospective follow-up study in a Dutch level I trauma center

BACKGROUND
Controlling non-compressible torso hemorrhage (NCTH) is one of the biggest challenges trauma surgeons face today. Over the last years the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in the management of traumatic NCTH is rising. However, it is not yet widely adopted in Dutch trauma centers. REBOA is an endovascular technique to temporarily obstruct blood flow to the distal circulation using a compliant balloon catheter in trauma patients suffering from major truncal or junctional bleeding. REBOA is considered as a less invasive alternative to open aortic cross clamping for certain indications. It has recently been introduced in Erasmus MC Rotterdam as adjunct in the management of hemorrhagic trauma patients.

AIM
The primary aim of this study is to evaluate the success rate of REBOA cases in a Dutch level I trauma center.

The secondary aims are:
1) To evaluate the time needed to obtain hemorrhage control with REBOA;
2) To evaluate the complications related to the use of REBOA;
3) To evaluate the survival rate in the trauma patients treated using REBOA;
4) To make a careful evaluation of every step in the REBOA procedure, the circumstances under which it is performed and its effect; and
5) To increase the knowledge of the patient demographics, injury characteristics, clinical parameters, the deployed resources and interventions, and hospital course of trauma patients treated using REBOA.

STUDY DESIGN
Prospective observational study

POPULATION
Trauma patients who are treated using REBOA.

INTERVENTION
No interventions will be used.

ENDPOINTS
The primary outcome measure is whether REBOA was successful. The secondary outcome measures are time needed to obtain hemorrhage control with REBOA, complications, survival, REBOA procedure data, patient demographics, injury characteristics, field data, admission data, and hospital course of patients treated using REBOA.

RECRUITING COUNTRIES
The Netherlands.

REBOA is expected to be successful in raising the central systolic blood pressure in trauma patients suffering from major truncal or junctional hemorrhage.

During hospital admission and 30 days after trauma or until hospital discharge if hospital stay exceeds the 30-day follow-up period.

Not applicable