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

Status unconfirmed · Not applicable

Conditions studied: Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT03231202

Run by

Oslo University Hospital

People needed

224

Starts

2017-07-01

Expected to finish

2019-08-01

Last updated by the study team

2017-07-27

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oslo Universtity Hospital — Oslo, Norway (enrolling)
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Harborview Medical Center — Seattle, Washington, United States
• Liverpool Hospital — Sydney, Australia
• McGill University Health Centre — Montreal, Canada
• Rigshospitalet — Copenhagen, Denmark
• Kliniken der Stadt Köln — Cologne, Germany
• University Medical Center — Utrecht, Netherlands
• Karolinska Institute — Stockholm, Sweden
• Royal London Hospital — London, United Kingdom
• Denver Health Medical Center — Denver, Colorado, United States
• Nottingham University Hospital — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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