Benefit of Prophylactic Embolization of the Splenic Salvage (NCT02021396) | Clinical Trial Compass
CompletedNot Applicable
Benefit of Prophylactic Embolization of the Splenic Salvage
France140 participantsStarted 2014-02
Plain-language 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
Who can participate
Age range18 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).…