Prospective observational study on the effectiveness and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in traumatic shock patients due to torso hemorrhage

Prospective observational study on the effectiveness and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in traumatic shock patients due to torso hemorrhage - Effectiveness of REBOA in traumatic shock

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035458

Enrollment

500

Registered

2019-01-06

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

traumatic hemorrhagic shock patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Traumatic shock patients due to torso hemorrhage who is judged to require hemostasis (surgery and/or interventional radiology) Baseline is defined as arrival or contact with medical team Include only those patients whose doctor decided to stop bleeding within 60 minutes of arrival or contact with medical team (*not to start hemostasis) Include multiple injuries regardless of head injury Age of16 years and over (estimated weight 40 kg or more when age is unknown).

Exclusion criteria

Exclusion criteria: Cardiac arrest before contact with physician

Design outcomes

Primary

Measure	Time frame
In-hospital mortality	—

Secondary

Measure	Time frame
Secondary endpoints include presence or absence of hemorrhagic death judged by the attending physician, blood transfusion requirement within first 24 hours, complications (systemic complications, device-related complications, and vascular access-related complications), ICU-free days and ventilator free days of 28 days after hospitalization. Complications and their outcomes are defined as follows: Systemic complications: renal dysfunction (with or without renal replacement therapy), intestinal ischemia (presence or absence of intestinal necrosis by contrast CT or surgery), cerebral infarction (nerve dropout findings such as new onset hemiplegia and image findings), spinal cord infarction (limb paralysis or paralysis), aortic injury (X-ray or CT, angiography or judgment by attending physician) Device-related complications: catheter position abnormality (presence or absence of indwelling in an unintended vessel), presence or absence of balloon migration (downstream movement of the balloon with less pressure increase than expected), presence or absence of balloon rupture Access-related complications: vascular dissection, pseudoaneurysm (repair surgery or intravascular treatment), puncture hematoma, retroperitoneal hematoma (required hemostasis procedure), thromboembolism, vascular stenosis (thrombectomy, angioplasty, or surgical operation), lower limb ischemia (fasciotomy or lower limb amputation)	—

Measure

Time frame

Secondary endpoints include presence or absence of hemorrhagic death judged by the attending physician, blood transfusion requirement within first 24 hours, complications (systemic complications, device-related complications, and vascular access-related complications), ICU-free days and ventilator free days of 28 days after hospitalization. Complications and their outcomes are defined as follows: Systemic complications: renal dysfunction (with or without renal replacement therapy), intestinal ischemia (presence or absence of intestinal necrosis by contrast CT or surgery), cerebral infarction (nerve dropout findings such as new onset hemiplegia and image findings), spinal cord infarction (limb paralysis or paralysis), aortic injury (X-ray or CT, angiography or judgment by attending physician) Device-related complications: catheter position abnormality (presence or absence of indwelling in an unintended vessel), presence or absence of balloon migration (downstream movement of the balloon with less pressure increase than expected), presence or absence of balloon rupture Access-related complications: vascular dissection, pseudoaneurysm (repair surgery or intravascular treatment), puncture hematoma, retroperitoneal hematoma (required hemostasis procedure), thromboembolism, vascular stenosis (thrombectomy, angioplasty, or surgical operation), lower limb ischemia (fasciotomy or lower limb amputation)

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Countries

Japan,Asia(except Japan)

Contacts

Public ContactYosuke Matsumura

Chiba University Graduate School of Medicine Department of Emergency and Critical Care Medicine

yousuke.jpn4035@gmail.com0432227171

Outcome results