Clinical trial NCT02021396: Benefit of Prophylactic Embolization of the Splenic Salvage
Official title: Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Splenic Trauma
Keywords: splenic rescue; splenectomy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Rescue rate
timeFrame: Splenic Rescue at 30 days
Secondary outcomes:
measure: Mortality
timeFrame: At 1 and 6 months
measure: Morbidity
timeFrame: at 1 and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble Alpes
state: Rhone Alpes
Study officials:
affiliation: University Clinic of Digestive Surgery and Emergency
name: Pr Catherine ARVIEUX
role: PRINCIPAL_INVESTIGATOR
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