Benefit of Prophylactic Embolization of the Splenic Salvage
NCT ID: NCT02021396
Last Updated: 2018-07-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
140 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-02-28
Study Completion Date
2018-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Splenic Trauma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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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
Group Type
EXPERIMENTAL
Embolization
Intervention Type
PROCEDURE
this arm of the study was interventional (splenic artery embolization)
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
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Embolization
this arm of the study was interventional (splenic artery embolization)
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
74 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pr Catherine ARVIEUX
Role: PRINCIPAL_INVESTIGATOR
University Clinic of Digestive Surgery and Emergency
Locations
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University Hospital Grenoble Alpes
Grenoble, Auvergne-Rhône-Alpes, France
Site Status
Countries
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France
References
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Read RC, Finch RG. Prophylaxis after splenectomy. J Antimicrob Chemother. 1994 Jan;33(1):4-6. doi: 10.1093/jac/33.1.4. No abstract available.
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Cullingford GL, Watkins DN, Watts AD, Mallon DF. Severe late postsplenectomy infection. Br J Surg. 1991 Jun;78(6):716-21. doi: 10.1002/bjs.1800780626.
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Shih HC, Wang CY, Wen YS, Wu JK, Huang MS, Huang CI, Lee CH. Spleen artery embolization aggravates endotoxin hyporesponse of peripheral blood mononuclear cells in patients with spleen injury. J Trauma. 2010 Mar;68(3):532-7. doi: 10.1097/TA.0b013e3181a7bfaa.
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BACKGROUND
Tominaga GT, Simon FJ Jr, Dandan IS, Schaffer KB, Kraus JF, Kan M, Carlson SR, Moreland S 3rd, Nelson T, Schultz P, Eastman AB. Immunologic function after splenic embolization, is there a difference? J Trauma. 2009 Aug;67(2):289-95. doi: 10.1097/TA.0b013e3181a5e7e2.
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BACKGROUND
Tidadini F, Martinet E, Quesada JL, Foote A, El Wafir C, Girard E, Arvieux C; SPLASH study group. Patient factors associated with embolization or splenectomy within 30 days of initiating surveillance for splenic trauma. Emerg Radiol. 2024 Dec;31(6):823-833. doi: 10.1007/s10140-024-02285-3. Epub 2024 Oct 4.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
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DCIC 13 02
Identifier Type: -
Identifier Source: org_study_id
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