The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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 - 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.
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Delayed bleeding episode - Incidence. Delayed bleeding episode is defined as hemodynamically unstable patient, CT verified contrast blush or drop in hemoglobin/hematocrit.
Timepoint [1] 0 0
6-12 weeks
Secondary outcome [2] 0 0
All cause and spleen related mortality - Incidence
Timepoint [2] 0 0
6-12 weeks
Secondary outcome [3] 0 0
All cause and spleen related failure of NOM - Incidence
Timepoint [3] 0 0
6-12 weeks
Secondary outcome [4] 0 0
Pseudoaneurysms (PSA) - Incidence
Timepoint [4] 0 0
6-12 weeks
Secondary outcome [5] 0 0
Symptomatic thromboembolic events - Incidence
Timepoint [5] 0 0
6-12 weeks
Secondary outcome [6] 0 0
Other spleen related complications - Incidence
Timepoint [6] 0 0
6-12 weeks
Secondary outcome [7] 0 0
Angiography related complications - Incidence
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
Gender
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
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.
Trial website
https://clinicaltrials.gov/show/NCT03231202
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
iagaski@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03231202