Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
Wounds and Injuries
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring Non-operative management, Splenic Injury, Blunt, Splenic artery embolization, Trauma
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
Sites / Locations
- Denver Health Medical Center
- University of Pittsburgh School of Medicine
- Harborview Medical Center
- Liverpool Hospital
- McGill University Health Centre
- Rigshospitalet
- Kliniken der Stadt Köln
- University Medical Center
- Oslo Universtity HospitalRecruiting
- Karolinska Institute
- Royal London Hospital
- Nottingham University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Embolization
Observation
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.
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.