Benefit of Prophylactic Embolization of the Splenic Salvage

NCT02021396 | Completed DMC

• 1 other identifier: DCIC 13 02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Splenic Trauma

Keywords

splenic rescue; splenectomy

Outcome Measures

Primary Outcomes (1)

• Rescue rate

  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.

  Splenic Rescue at 30 days

Secondary Outcomes (2)

• Mortality

  At 1 and 6 months

• Morbidity

  at 1 and 6 months

Study Arms (2)

Embolization

EXPERIMENTAL

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

Procedure: Embolization

Surveillance

NO INTERVENTION

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

Interventions

Embolization PROCEDURE

this arm of the study was interventional (splenic artery embolization)

Embolization

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• 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 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble Alpes

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

Related Publications (48)

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  PMID: 39365384 DERIVED

• Arvieux C, Frandon J, Tidadini F, Monnin-Bares V, Foote A, Dubuisson V, Lermite E, David JS, Douane F, Tresallet C, Lemoine MC, Rodiere M, Bouzat P, Bosson JL, Vilotitch A, Barbois S, Thony F; Splenic Arterial Embolization to Avoid Splenectomy (SPLASH) Study Group. Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial. JAMA Surg. 2020 Dec 1;155(12):1102-1111. doi: 10.1001/jamasurg.2020.3672.

  PMID: 32936242 DERIVED

MeSH Terms

Interventions

Embolization, Therapeutic

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Pr Catherine ARVIEUX

  University Clinic of Digestive Surgery and Emergency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

FR (1)