Benefit of Prophylactic Embolization of the Splenic Salvage (Splash)
Splenic Trauma
About this trial
This is an interventional other trial for Splenic Trauma focused on measuring splenic rescue; splenectomy
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
- Patients who underwent partial or total splenectomy before inclusion
- Patient having acquired or innate immune deficiency
- All indications not permitting the achievement of embolization
- Pregnant woman
- Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
- Patient currently participating in a clinical study or having participated in a clinical study in the month preceding the inclusion
- Patient with a condition or a history of mental or psychiatric disorder or any other factor limiting their ability to participate in an informed manner and to comply with the protocol.
Sites / Locations
- University Hospital Grenoble Alpes
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Embolization
Surveillance
this arm of the study was interventional (embolization) with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180) read by 2 expert radiologists blinded to the study arm
this arm of the study was non-interventional (surveillance), with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180 ) read by 2 expert radiologists blinded to the study arm