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Benefit of Prophylactic Embolization of the Splenic Salvage (Splash)

Primary Purpose

Splenic Trauma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Embolization
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Splenic Trauma focused on measuring splenic rescue; splenectomy

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University Hospital Grenoble Alpes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Embolization

Surveillance

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality
Morbidity

Full Information

First Posted
December 3, 2013
Last Updated
July 24, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02021396
Brief Title
Benefit of Prophylactic Embolization of the Splenic Salvage
Acronym
Splash
Official Title
Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Splenic Trauma
Keywords
splenic rescue; splenectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Embolization
Arm Type
Experimental
Arm 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
Arm Title
Surveillance
Arm Type
No Intervention
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Embolization
Intervention Description
this arm of the study was interventional (splenic artery embolization)
Primary Outcome Measure Information:
Title
Rescue rate
Description
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.
Time Frame
Splenic Rescue at 30 days
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
At 1 and 6 months
Title
Morbidity
Time Frame
at 1 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr Catherine ARVIEUX
Organizational Affiliation
University Clinic of Digestive Surgery and Emergency
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble Alpes
City
Grenoble
State/Province
Rhone Alpes
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Benefit of Prophylactic Embolization of the Splenic Salvage

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