Status:
UNKNOWN
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
Lead Sponsor:
Oslo University Hospital
Conditions:
Wounds and Injuries
Eligibility:
All Genders
16-80 years
Phase:
NA
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) a...
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 observat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03231202
Start Date
July 1 2017
End Date
August 1 2019
Last Update
July 27 2017
Active Locations (12)
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1
Denver Health Medical Center
Denver, Colorado, United States, 80204
2
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
3
Harborview Medical Center
Seattle, Washington, United States, 98104
4
Liverpool Hospital
Sydney, Australia