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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03231202
Registration number
NCT03231202
Ethics application status
Date submitted
5/07/2017
Date registered
27/07/2017
Date last updated
27/07/2017
Titles & IDs
Public title
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
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Scientific title
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.
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Secondary ID [1]
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2016/15608
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Wounds and Injuries
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Condition category
Condition code
Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Embolization
Experimental: 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.
The study does not interfere with local diagnostic work-up and treatment protocols.
No Intervention: Observation - 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.
Treatment: Surgery: 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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Failure of NOM
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Assessment method [1]
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The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive SAE as part of NOM and the patients not undergoing SAE. The primary endpoint is the proportion of subjects failing NOM due to spleen related bleeding within 7 days of injury. All analyses will be based on an intention to treat analysis.
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Timepoint [1]
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7 days
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Secondary outcome [1]
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Delayed bleeding episode
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Assessment method [1]
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Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.
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Timepoint [1]
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6-12 weeks
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Secondary outcome [2]
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All cause and spleen related mortality
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Assessment method [2]
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Incidence
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Timepoint [2]
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6-12 weeks
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Secondary outcome [3]
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All cause and spleen related failure of NOM
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Assessment method [3]
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Incidence
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Timepoint [3]
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6-12 weeks
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Secondary outcome [4]
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Pseudoaneurysms (PSA)
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Assessment method [4]
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Incidence
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Timepoint [4]
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6-12 weeks
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Secondary outcome [5]
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Symptomatic thromboembolic events
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Assessment method [5]
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Incidence
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Timepoint [5]
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6-12 weeks
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Secondary outcome [6]
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Other spleen related complications
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Assessment method [6]
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Incidence
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Timepoint [6]
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6-12 weeks
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Secondary outcome [7]
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Angiography related complications
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Assessment method [7]
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Incidence
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Timepoint [7]
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6-12 weeks
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Eligibility
Key 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
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2019
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Actual
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Sample size
Target
224
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Liverpool Hospital - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Pennsylvania
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Country [3]
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United States of America
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State/province [3]
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Washington
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Country [4]
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Canada
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State/province [4]
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Montreal
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Country [5]
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Denmark
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State/province [5]
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Copenhagen
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Country [6]
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Germany
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State/province [6]
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Cologne
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Country [7]
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Netherlands
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State/province [7]
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Utrecht
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Country [8]
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Norway
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State/province [8]
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Oslo
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Country [9]
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Sweden
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State/province [9]
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Stockholm
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Country [10]
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United Kingdom
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State/province [10]
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London
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Country [11]
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United Kingdom
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State/province [11]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Other
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Name
Oslo University Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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) 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03231202
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christine Gaarder, MD, PhD
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Address
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Head, Department of Traumatology
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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iver Anders Gaski, MD
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Address
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Country
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Phone
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90063971
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03231202
Download to PDF