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Benefit of Prophylactic Embolization of the Splenic Salvage (Splash)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021396
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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

Condition or disease Intervention/treatment Phase
Splenic Trauma Procedure: Embolization Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
Study Start Date : February 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : June 2018

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: At 1 and 6 months ]
  2. Morbidity [ Time Frame: at 1 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021396


Locations
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France
University Hospital Grenoble Alpes
Grenoble, Rhone Alpes, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Pr Catherine ARVIEUX University Clinic of Digestive Surgery and Emergency
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02021396    
Other Study ID Numbers: DCIC 13 02
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Grenoble:
splenic rescue; splenectomy
Additional relevant MeSH terms:
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Wounds and Injuries