Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334263
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-21
Brief Title:
Splenic Embolisation Decisions
Sponsor:
University Hospital Plymouth NHS Trust
Organization:
University Hospital Plymouth NHS Trust
Study Overview
Official Title:
Decision to Treat Acute Traumatic Splenic Artery Injury in the Context of Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPEED
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
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 DCS1
Splenic injury is classified according to the American Association of Trauma Surgery grade grades 1 to 52 with increased severity traumatic injury according to the higher numerical value SE is typically performed in higher grade 34 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 20123 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 4 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 Thetechnique and method of embolisaiton 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
Splenic injury is classified according to the American Association of Trauma Surgery grade grades 1 to 52 with increased severity traumatic injury according to the higher numerical value SE is typically performed in higher grade 34 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 20123 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 4 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 Thetechnique and method of embolisaiton 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None