Splenic Embolisation Decisions

NCT06334263 | Recruiting

• 1 other identifier: 332302
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma; Spleen Injury

Outcome Measures

Primary Outcomes (5)

• 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.

  5 years

• Number of On call IR consultants affecting embolisation rate

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

  5 years

• What is the splenic salvage rate for proximal versus distal embolisation

  What is the splenic salvage rate for proximal versus distal embolisation

  5 years

• Readmission rate of splenic embolisation versus splenectomy

  Readmission rate of splenic embolisation versus splenectomy

  5 years

• Embolisation failure

  Embolisation failure rate

  5 years

Study Arms (3)

Conservative management

No intervention for splenic injury other than supportive care

Splenic embolisation

Interventional radiology guided splenic artery embolisation

Splenectomy

Surgical splenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• CT not available to radiologically grade the Splenic injury

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL6 5DH, United Kingdom

RECRUITING

Related Publications (6)

• 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.

  PMID: 22271075 BACKGROUND

• 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.

  PMID: 30462622 BACKGROUND

• 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.

  PMID: 27791418 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 21217497 BACKGROUND

• 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.

  PMID: 26139039 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 27, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

GB (1)