Benefit of Prophylactic Embolization of the Splenic Salvage (Splash)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Splenic Trauma

Treatments: Procedure: Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02021396

DCIC 13 02

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Embolization

Experimental group

Description:

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

Treatment:

Procedure: Embolization

Surveillance

No Intervention group

Description:

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