Benefit of Prophylactic Embolization of the Splenic Salvage (Splash)

July 24, 2018 updated by: University Hospital, Grenoble

Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone Alpes
      • Grenoble, Rhone Alpes, France, 38000
        • University Hospital Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Embolization
this arm of the study was interventional (splenic artery embolization)
No Intervention: Surveillance
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue rate
Time Frame: 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.
Splenic Rescue at 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: At 1 and 6 months
At 1 and 6 months
Morbidity
Time Frame: at 1 and 6 months
at 1 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Pr Catherine ARVIEUX, University Clinic of Digestive Surgery and Emergency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 13 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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