Clinical trial NCT03231202: Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wounds and Injuries
Keywords: Non-operative management
Splenic Injury
Blunt
Splenic artery embolization
Trauma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 224
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure of NOM
timeFrame: 7 days
Secondary outcomes:
measure: Delayed bleeding episode
timeFrame: 6-12 weeks
measure: All cause and spleen related mortality
timeFrame: 6-12 weeks
measure: All cause and spleen related failure of NOM
timeFrame: 6-12 weeks
measure: Pseudoaneurysms (PSA)
timeFrame: 6-12 weeks
measure: Symptomatic thromboembolic events
timeFrame: 6-12 weeks
measure: Other spleen related complications
timeFrame: 6-12 weeks
measure: Angiography related complications
timeFrame: 6-12 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Sydney
country: Australia
facility: Liverpool Hospital
city: Montreal
country: Canada
facility: McGill University Health Centre
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Cologne
country: Germany
facility: Kliniken der Stadt Köln
city: Utrecht
country: Netherlands
facility: University Medical Center
city: Oslo
country: Norway
facility: Oslo Universtity Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institute
city: London
country: United Kingdom
facility: Royal London Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Head, Department of Traumatology
name: Christine Gaarder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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