UnknownNot Applicable

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

United States, Australia, Canada224 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range16 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Failure of NOM

Timeframe: 7 days

Trial details

NCT IDNCT03231202

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-01

Contact for this trial

iver Anders Gaski, MD

90063971 iagaski@gmail.com

View on ClinicalTrials.gov More Wounds and Injuries trials