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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03231202




Registration number
NCT03231202
Ethics application status
Date submitted
5/07/2017
Date registered
27/07/2017

Titles & IDs
Public title
Splenic Injury Embolization - the Question About NOM (SInE Qua NOM)
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.
Secondary ID [1] 0 0
2016/15608
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wounds and Injuries 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure of NOM
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Delayed bleeding episode
Timepoint [1] 0 0
6-12 weeks
Secondary outcome [2] 0 0
All cause and spleen related mortality
Timepoint [2] 0 0
6-12 weeks
Secondary outcome [3] 0 0
All cause and spleen related failure of NOM
Timepoint [3] 0 0
6-12 weeks
Secondary outcome [4] 0 0
Pseudoaneurysms (PSA)
Timepoint [4] 0 0
6-12 weeks
Secondary outcome [5] 0 0
Symptomatic thromboembolic events
Timepoint [5] 0 0
6-12 weeks
Secondary outcome [6] 0 0
Other spleen related complications
Timepoint [6] 0 0
6-12 weeks
Secondary outcome [7] 0 0
Angiography related complications
Timepoint [7] 0 0
6-12 weeks

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
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2019
Actual
Sample size
Target
224
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Washington
Country [4] 0 0
Canada
State/province [4] 0 0
Montreal
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
Germany
State/province [6] 0 0
Cologne
Country [7] 0 0
Netherlands
State/province [7] 0 0
Utrecht
Country [8] 0 0
Norway
State/province [8] 0 0
Oslo
Country [9] 0 0
Sweden
State/province [9] 0 0
Stockholm
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
Oslo University Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christine Gaarder, MD, PhD
Address 0 0
Head, Department of Traumatology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
iver Anders Gaski, MD
Address 0 0
Country 0 0
Phone 0 0
90063971
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Stassen NA, Bhullar I, Cheng JD, Crandall ML, Frie... [More Details]
Journal Velmahos GC, Zacharias N, Emhoff TA, Feeney JM, Hu... [More Details]
Journal Davis KA, Fabian TC, Croce MA, Gavant ML, Flick PA... [More Details]
Journal Schurr MJ, Fabian TC, Gavant M, Croce MA, Kudsk KA... [More Details]
Journal McIntyre LK, Schiff M, Jurkovich GJ. Failure of no... [More Details]
Journal Sclafani SJ, Weisberg A, Scalea TM, Phillips TF, D... [More Details]
Journal Miller PR, Chang MC, Hoth JJ, Mowery NT, Hildreth ... [More Details]
Journal Bhullar IS, Frykberg ER, Siragusa D, Chesire D, Pa... [More Details]
Journal Schimmer JA, van der Steeg AF, Zuidema WP. Splenic... [More Details]
Journal Haan JM, Bochicchio GV, Kramer N, Scalea TM. Nonop... [More Details]
Journal Skattum J, Titze TL, Dormagen JB, Aaberge IS, Bech... [More Details]
Journal Peitzman AB, Harbrecht BG, Rivera L, Heil B; Easte... [More Details]
Journal Cirocchi R, Boselli C, Corsi A, Farinella E, Listo... [More Details]
Journal Zarzaur BL, Vashi S, Magnotti LJ, Croce MA, Fabian... [More Details]
Journal Clancy AA, Tiruta C, Ashman D, Ball CG, Kirkpatric... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03231202