Benefit of Prophylactic Embolization of the Splenic Salvage

Not Applicable

Completed

• Conditions: Splenic Trauma
• Interventions: Procedure: Embolization

• Registration Number: NCT02021396
• Lead Sponsor: University Hospital, Grenoble

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Study Start: 2014-02
• Primary Completion: 2017-12
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embolization	Embolization	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

Primary Outcome Measures

Name	Time	Method
Rescue rate	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	At 1 and 6 months
Morbidity	at 1 and 6 months

Trial Locations

Locations (1)

University Hospital Grenoble Alpes; 🇫🇷 Grenoble, Rhone Alpes, France