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CompletedNCT06334263SPEEDUpdated Sep 17, 2026

Splenic Embolisation Decisions

An observational study in Trauma and Spleen Injury, sponsored by University Hospital Plymouth NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Hospital Plymouth NHS Trust · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
202
Ages
18 Years and older
Sex
All
01

Study summary

The spleen is often injured when the body sustains trauma. This leads to bleeding. The bleeding can be stopped by a big operation cutting open the belly or a small hole in your groin where a blood vessel can be accessed and through which the bleeding can be stopped. We do not know what types of injuries it is best to use this procedure. We do not know why we do not use the smaller technique in some instances. We also do not know exactly which of a number of ways to stop the bleeding could be better. We have a big data set in the trauma and audit research network (TARN) which we would like to use to help answer these questions and design further studies to better answer the questions. Adding a few other pieces of data, we are able to answer key questions into how the spleen will best be treated in trauma.

Read the detailed description

Splenic embolisation (SE) is a minimally invasive procedure whereby the splenic artery is blocked to stop bleeding from the spleen. This is typically undertaken in the context of acute traumatic splenic injury, diagnosed using Computed Tomography (CT) Scan by a diagnostic radiologist. The vessel can be accessed using wires and catheters under imaging guidance with access typically though the common femoral artery. This has been shown to be a viable management option in patients who are traumatically injured, in the absence of concurrent immediately life-threatening other injuries requiring damage control surgery (DCS).

Splenic injury is classified according to the American Association of Trauma Surgery (AAST) grade (grades 1 to 5), with increased severity traumatic injury according to the higher numerical value. SE is typically performed in higher grade (3/4) splenic injuries, although the gold standard of management of Grade 5 is considered surgical resection. There is no current definitive consensus as to appropriateness of the management of these grades although there is a trend towards embolisation since the inception of trauma networks in England in 2012. The 22 Trauma centres now function as a hub for trauma within their specified area and had the aim of developing trauma services and improving clinical care. The 22 Adult Trauma centres within England are listed in appendix A. There are few guidelines regarding the availability and specifications of interventional radiology (IR) provision at Major Trauma Centres (MTCs) and there is no available data on the impact of IR on-call structure and quality or location of IR facilities on the splenic conservation rate and time to treatment. SE technique and rate are variable and depend on multiple factors. These factors include the time to CT report, the availability of On Call IR services, the method of contact of the IR, availability of a hybrid theatre and the associated injuries. A recent survey of British Society of Interventional Radiology (BSIR) members, undertaken as part of the BSIR audit and registry committee, demonstrated wide variability in the management and treatment of splenic injuries with respect to SE (unpublished data). This was due to a number of factors regarding service design and decisions around appropriateness and method of embolisation. Splenic embolisation can be performed in two main ways, either with a proximal occlusion of the splenic artery outside of its hilum, or within the actual splenic tissue having selected the arterial branch that is demonstrated as bleeding. The embolisation (stopping of the bleeding) can be performed using a variety of methods, including coils, plugs, gelfoam or glue to stop the blood getting to the damaged vessel. The technique and method of embolisation also have a poor evidence base. No multicentre UK based dataset has been published. This highlights the lack of consensus, guidelines, and research in this area. Work on the available retrospective dataset which are available through Trauma and Audit Research Network (TARN) should be undertaken to analyse the current situation to enable design of multi-centre prospective research. This work will benefit patients by establishing an improved evidence base regarding the optimum service design and treatment pathway. We aim to benefit the NHS by clearly identifying factors that improve the successful embolisation rate, a less invasive procedure than damage control surgery (DCS) whereby a surgeon would remove the spleen through a large incision in the abdomen. We aim to clarify the role of and support the development of IR within the trauma setting by establishing a more evidence-based practice to support interventional radiologists in their decision-making around splenic embolisation in the context of Acute Traumatic Splenic injury (ATSI). The determination of the impact IR service design on outcomes will enable improved management decisions on overall patient care.

02

Conditions studied

  • Trauma
  • Spleen Injury

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 202 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients identified as having an acute traumatic splenic injury grade AAST 2-5 on the TARN database between the given dates will be included. Hospitals who decline participation in the data collection will have their patients excluded from the analysis excluded by site as identified in TARN database

Inclusion criteria

All patients who had traumatic splenic injury between 01/01/2016 and 31/12/2020 with data available from TARN CT available for review.

Exclusion criteria

EXCLUSION CRITERIA:

CT not available to radiologically grade the Splenic injury

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
202 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Conservative management

    No intervention for splenic injury other than supportive care

  • Splenic embolisation

    Interventional radiology guided splenic artery embolisation

  • Splenectomy

    Surgical splenectomy

06

What researchers measure

Primary outcomes

  1. Splenic embolisation rate as percentage of; acute splenic trauma per Major Trauma Centre (MTC)

    Splenic embolisation rate as percentage of; acute splenic trauma, per injury grade and per Major Trauma Centre (MTC). Failure of conservative management rate and splenectomy rate.

    Time frame: 5 years

  2. Number of On call IR consultants affecting embolisation rate

    Does the number of on call IR consultants affect the embolisaiton rate

    Time frame: 5 years

  3. What is the splenic salvage rate for proximal versus distal embolisation

    What is the splenic salvage rate for proximal versus distal embolisation

    Time frame: 5 years

  4. Readmission rate of splenic embolisation versus splenectomy

    Readmission rate of splenic embolisation versus splenectomy

    Time frame: 5 years

  5. Embolisation failure

    Embolisation failure rate

    Time frame: 5 years

07

Study locations

1 site
  • University Hospitals Plymouth NHS Trust
    Plymouth, Devon PL6 5DH, United Kingdom
08

References and documents

Publications

  • Chakraverty S, Flood K, Kessel D, McPherson S, Nicholson T, Ray CE Jr, Robertson I, van Delden OM. CIRSE guidelines: quality improvement guidelines for endovascular treatment of traumatic hemorrhage. Cardiovasc Intervent Radiol. 2012 Jun;35(3):472-82. doi: 10.1007/s00270-012-0339-7. Epub 2012 Jan 20. No abstract available. PubMed 22271075 ↗
  • Kozar RA, Crandall M, Shanmuganathan K, Zarzaur BL, Coburn M, Cribari C, Kaups K, Schuster K, Tominaga GT; AAST Patient Assessment Committee. Organ injury scaling 2018 update: Spleen, liver, and kidney. J Trauma Acute Care Surg. 2018 Dec;85(6):1119-1122. doi: 10.1097/TA.0000000000002058. No abstract available. PubMed 30462622 ↗
  • Yiannoullou P, Hall C, Newton K, Pearce L, Bouamra O, Jenks T, Scrimshire AB, Hughes J, Lecky F, Macdonald A. A review of the management of blunt splenic trauma in England and Wales: have regional trauma networks influenced management strategies and outcomes? Ann R Coll Surg Engl. 2017 Jan;99(1):63-69. doi: 10.1308/rcsann.2016.0325. Epub 2016 Oct 28. PubMed 27791418 ↗
  • 4. RCR 2015 - Standards for practice and guidance for trauma radiology in the severely injured patient. Available at: https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfcr155_traumaradiol.pdf
  • Schnuriger B, Inaba K, Konstantinidis A, Lustenberger T, Chan LS, Demetriades D. Outcomes of proximal versus distal splenic artery embolization after trauma: a systematic review and meta-analysis. J Trauma. 2011 Jan;70(1):252-60. doi: 10.1097/TA.0b013e3181f2a92e. PubMed 21217497 ↗
  • Foley PT, Kavnoudias H, Cameron PU, Czarnecki C, Paul E, Lyon SM. Proximal Versus Distal Splenic Artery Embolisation for Blunt Splenic Trauma: What is the Impact on Splenic Immune Function? Cardiovasc Intervent Radiol. 2015 Oct;38(5):1143-51. doi: 10.1007/s00270-015-1162-8. Epub 2015 Jul 3. PubMed 26139039 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06334263
Lead sponsor
University Hospital Plymouth NHS Trust
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Jul 22, 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Sep 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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