Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)

Study Overview
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Brief Summary
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The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.

Detailed Description
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This randomised controlled study will follow the clinical course of hemodynamically normal trauma patients with Organ Injury Scale (OIS) grade 4 or 5 blunt splenic injuries, undergoing SAE or observation only until day 7 post injury. Only hemodynamically normal patients will be considered for enrolment into the study, and written informed consent from the patient is required. CONTROL The control arm in this randomized controlled trial will include only NOM patients diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will comprise clinical observation according to local routines and protocols. The patients will be observed with special focus on delayed bleeding and failure of NOM. A contrast enhanced US or CT scan with arterial phase will be performed on day 3-5 to exclude PSA. On day 7, the decision to perform SAE, splenectomy or continue NOM is left to the discretion of each participating institution, and registered in the case report form (CRF). INTERVENTION The intervention arm will perform SAE as a central embolization of the splenic artery. Additional peripheral embolization is left to the discretion of the interventional radiologist. Each institution decides whether patients in the SAE group are to undergo immunization or not. The study does not interfere with local diagnostic work-up and treatment protocols. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM leading to fewer splenectomies in this group of patients without concomitant increased complication rates. Additionally, we want to explore the effects of pre-emptive SAE vs observation alone on all cause failure rate, operative procedures, repeat angiography rate, complications, critical care stay, and mortality.

Official Title
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A Multi-centre, Prospective, Randomized Controlled Study to Compare Outcomes of Non-operative Management (NOM) With and Without Splenic Arterial Embolization (SAE) in Hemodynamically Stable OIS Grade 4 and 5 Splenic Injuries.

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Procedure: Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: blunt splenic injury OIS grade 4 or 5 Adult trauma patients (according to local definitions) Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM Randomised within 48 hours of injury Written informed consent is obtained Exclusion Criteria: Hemodynamically compromised (not suitable for NOM) Needing transfusions CT shows evidence of significant contrast extravasation Other indications for laparotomy Prisoners Pregnant >80 years old Penetrating injury Contraindication to iv contrast

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization<br>The intervention arm will perform SAE as a central embolization of the splenic artery. Additional peripheral embolization is left to the discretion of the interventional radiologist. The study does not interfere with local diagnostic work-up and treatment protocols. | Procedure: Embolization<br>* The intervention arm will perform SAE as a central embolization of the splenic artery. Additional peripheral embolization is left to the discretion of the interventional radiologist.<br>* Other names: Splenic artery embolization (SAE);|
| No Intervention: Observation<br>The control arm in this randomized controlled trial will include only NOM patients diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will comprise clinical observation according to local routines and protocols. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of NOM | The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive SAE as part of NOM and the patients not undergoing SAE. The primary endpoint is the proportion of subjects failing NOM due to spleen related bleeding within 7 days of injury. All analyses will be based on an intention to treat analysis. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed bleeding episode | Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit. | 6-12 weeks | 
| All cause and spleen related mortality | Incidence | 6-12 weeks | 
| All cause and spleen related failure of NOM | Incidence | 6-12 weeks | 
| Pseudoaneurysms (PSA) | Incidence | 6-12 weeks | 
| Symptomatic thromboembolic events | Incidence | 6-12 weeks | 
| Other spleen related complications | Incidence | 6-12 weeks | 
| Angiography related complications | Incidence | 6-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-operative management, Splenic Injury, Blunt, Splenic artery embolization, Trauma