TraumaSPEEDNCT06334263
Splenic Embolisation Decisions
An observational study of Trauma and Spleen Injury, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Spleen Injury
- How many people
- 202 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2024to 31 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- All patients who had traumatic splenic injury between 01/01/2016 and 31/12/2020 with data available from TARN CT available for review.
Who cannot join
- CT not available to radiologically grade the Splenic injury
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL6 5DH
About this study
Official title: Decision to Treat Acute Traumatic Splenic Artery Injury in the Context of Trauma
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.
- Conditions
- Trauma, Spleen Injury
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conservative management | No intervention for splenic injury other than supportive care | |
| Splenic embolisation | Interventional radiology guided splenic artery embolisation | |
| Splenectomy | Surgical splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Number of On call IR consultants affecting embolisation rate
Does the number of on call IR consultants affect the embolisaiton rate
Measured: 5 years
What is the splenic salvage rate for proximal versus distal embolisation
What is the splenic salvage rate for proximal versus distal embolisation
Measured: 5 years
Readmission rate of splenic embolisation versus splenectomy
Readmission rate of splenic embolisation versus splenectomy
Measured: 5 years
Embolisation failure
Embolisation failure rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start22 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 202 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334263
- Sponsor's protocol ID
- 332302
- Acronym
- SPEED
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 22271075Kozar 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 30462622Yiannoullou 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 277914184. 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 21217497Foley 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision to Treat Acute Traumatic Splenic Artery Injury in the Context of Trauma
- ClinicalTrials.gov ID
- NCT06334263
- Acronym / sponsor ID
- SPEED / 332302
- Conditions
- Trauma, Spleen Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative management | – | –No intervention for splenic injury other than supportive care |
| Splenic embolisation | – | –Interventional radiology guided splenic artery embolisation |
| Splenectomy | – | –Surgical splenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who had traumatic splenic injury between 01/01/2016 and 31/12/2020 with data available from TARN CT available for review.
Key exclusion criteria (1 listed)
- CT not available to radiologically grade the Splenic injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Splenic embolisation rate as percentage of; acute splenic trauma per Major Trauma Centre (MTC)
Time frame: 5 years
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.
Number of On call IR consultants affecting embolisation rate
Time frame: 5 years
Does the number of on call IR consultants affect the embolisaiton rate
What is the splenic salvage rate for proximal versus distal embolisation
Time frame: 5 years
What is the splenic salvage rate for proximal versus distal embolisation
Readmission rate of splenic embolisation versus splenectomy
Time frame: 5 years
Readmission rate of splenic embolisation versus splenectomy
Embolisation failure
Time frame: 5 years
Embolisation failure rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 22271075Chakraverty 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.
- Background: PubMed 30462622Kozar 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.
- Background: PubMed 27791418Yiannoullou 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.
- Background4. 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: PubMed 21217497Schnuriger 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.
- Background: PubMed 26139039Foley 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.
- Individual participant dataSharing planned: Undecided
Related trials for Trauma
Not yet recruitingPhase 1
Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
Urologic Diseases, Male Urogenital Diseases
RecruitingPhase 1
NG004 in Incomplete Spinal Cord Injury Patients
Acute Spinal Cord Injury (SCI), Spinal Cord Diseases
Active, not recruiting
Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care
Stress Disorders, Post-Traumatic, Mental Disorders
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Corneal Trauma Diagnostic Study
Ocular Trauma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Spleen Injury, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splenic embolisation rate as percentage of; acute splenic trauma per Major Trauma Centre (MTC) (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334263, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.