NCT03231202

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
PROCEDURE	Embolization	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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2017-07-27
• Last updated: 2017-07-27

Locations

12 sites across 9 countries: United States, Australia, Canada, Denmark, Germany, Netherlands, Norway, Sweden, United Kingdom