Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.

University Hospital, Grenoble1 site in 1 country140 target enrollmentFebruary 2014

ConditionsSplenic Trauma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Splenic Trauma
Sponsor: University Hospital, Grenoble
Enrollment: 140
Locations: 1
Primary Endpoint: Rescue rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

June 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Grenoble

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged over 18 and under 75 years
•hemodynamically stable patients (systolic BP ≥ 90 mm Hg and no hemorrhagic shock)
•Suffered a closed splenic trauma within the last 48 hours
•A high risk of splenectomy:
•Reaching spleen Moore grade 4 and 5 in the abdominal injected CT or
•Reaching spleen Moore 3 and at least one of the following characteristics:
•Important Hemoperitoneum (when visible in the pelvic area).
•Severe associated impairment (NISS-New Injury Severity Score greater than or equal to 15)
•Patients volunteering to participate in the study, having signed the consent form or with the agreement of the family if the patient is not capable of giving consent; after adequate information and delivery of the patient and/or family information leaflet.
•covered by a social security scheme or beneficiary of such a plan.

Exclusion Criteria

•Patients whose usual residence is outside the European Economic Community
•Patient with hemodynamic instability (systolic blood pressure \<9 despite resuscitation maneuver)
•Patient with open splenic trauma
•Patient with surgical indication excluding the possibility of monitoring splenic trauma
•Patient with an indication for embolization of a body other than the spleen at the time of inclusion
•Patient with an indication for splenic embolization as a result of a post-traumatic vascular anomaly (active leakage of contrast agent, pseudoaneurysm or early splenic arteriovenous fistula).
•Patients aged less than 18 years and ≥ 75 years
•Patients with a previous spleen disease (tumor, infection, vascular anomaly intrasplenically)
•Patient with trauma Moore grade 1 or 2
•Patient with trauma grade Moore 5 with total ischemia of the spleen

Outcomes

Primary Outcomes

Rescue rate

Time Frame: Splenic Rescue at 30 days

The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of a splenectomy. The primary endpoint is an immunocompetent spleen i.e. intact or treated by surgical methods for splenic preservation of at least 50% of splenic vascularized tissue in the event of secondary laparotomy or with necrosis of less than 50% by volume. This criterion will be validated by a review of the initial scans by a panel of two senior radiologists blinded to the study arm.