Splenic Artery Embolization for Splenic Injuries

(ELSA-2 Trial)

Recruiting at 4 trial locations

Overseen By Evan Hudson, BS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Andrew J. Gunn

Disqualifiers: Immunocompromised, Pregnant, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate procedure

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods—using coils or plugs (known as vascular embolic coils or plugs)—to stop bleeding in the spleen after serious injuries. It targets individuals with high-grade splenic injuries (severe spleen damage) who will not undergo surgery. Candidates include those with a serious spleen injury confirmed by a CT scan, where doctors have opted against surgery. The trial aims to determine which method better controls bleeding. As an unphased trial, it offers an opportunity to contribute to medical knowledge and potentially benefit future patients with similar injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these embolization devices are safe for splenic artery embolization?

Research has shown that blocking the splenic artery with special coils or plugs is generally safe for treating serious spleen injuries. Studies have found that this method effectively stops bleeding and has manageable side effects. Most patients handle the procedure well, and complications rarely occur.

One study compared different devices, such as coils and plugs, and found that their use can speed up the procedure, potentially reducing the risk of complications. Another study found that using a plug alone effectively stopped bleeding without major side effects.

Overall, while any medical procedure carries some risk, evidence suggests that these devices are safe and well-tolerated for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about splenic artery embolization using vascular embolic coils and plugs because these treatments offer a minimally invasive alternative to traditional surgical options for splenic injuries. Unlike open surgery, which can be more risky and require longer recovery times, this technique involves blocking the splenic artery to control bleeding and promote healing, potentially reducing hospital stay and recovery time. The use of coils and plugs allows for precise control, which can lead to better outcomes and fewer complications compared to traditional methods. This innovative approach could transform how splenic injuries are managed, offering patients a safer and more efficient treatment option.

What evidence suggests that vascular embolic coils or plugs are effective for splenic injuries?

Research has shown that blocking the splenic artery with either coils or plugs effectively treats serious spleen injuries. In this trial, participants will be assigned to one of two treatment arms: one using vascular embolic coils and the other using vascular embolic plugs. One study found that this method stopped spleen bleeding in over 90% of cases. Another study noted that using plugs might be faster and more efficient than coils. The success rate with plugs was 100%, while coils had an 89% success rate and sometimes required additional procedures. These findings suggest that both methods work well, but plugs might be quicker and more effective. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals over 15 years old who have a high-grade splenic injury from trauma, as seen on a CT scan. They must be candidates for non-surgical treatment and weigh more than 50kg. People can't join if they have severe blood clotting issues, are pregnant or breastfeeding, don't speak English, are prisoners, immunocompromised, or unable to consent.

Inclusion Criteria

My spleen injury is being treated without surgery, as decided by my doctors.

I have a severe spleen injury shown on a CT scan.

I am 15 years old or older.

Exclusion Criteria

Non-English speakers

Breast-feeding

I weigh 50kg or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo splenic artery embolization using either vascular embolic coils or plugs

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes and technical success

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Vascular Embolic Coils or Plugs

Trial Overview The study tests how well two different devices—vascular embolic coils and plugs—work in blocking the splenic artery to control bleeding after serious spleen injuries. Patients will be randomly assigned one of these methods in multiple hospitals.

How Is the Trial Designed?

Group I: Active Comparator: Splenic artery embolization with vascular embolic coils Active Control 1 Intervention

Device: Splenic artery embolization with vascular embolic coils

Group II: Active Comparator: Splenic artery embolization with vascular embolic plugs Active Control 1 Intervention

Active Comparator: Splenic artery embolization with vascular embolic plugs

Vascular Embolic Coils or Plugs is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Gastroesophageal varices

Approved in United States as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Portal hypertension

Approved in Canada as Vascular Embolic Coils or Plugs for:

• High-grade splenic trauma
• Splenic artery aneurysms
• Gastroesophageal varices

Who Is Running the Clinical Trial?

Andrew J. Gunn

Lead Sponsor

Trials

1

Recruited

250+

Penumbra Inc.

Industry Sponsor

Trials

38

Recruited

10,800+

Published Research Related to This Trial

In a study of 26 patients with traumatic splenic injuries, both vascular plugs and endovascular coils were effective for proximal splenic artery embolization, achieving a 100% splenic salvage rate with no major complications.

Using vascular plugs resulted in significantly lower fluoroscopy times (14.5 minutes) compared to endovascular coils (34.0 minutes), suggesting a more efficient procedure without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular plugs are associated with reduced fluoroscopy times compared to endovascular coils in proximal splenic artery embolization in trauma. Glenn, AM., Huang, J., Gunn, AJ., et al.[2022]

In a study of 22 patients with blunt splenic injury, splenic artery embolization demonstrated a high splenic salvage rate of 91%, indicating its effectiveness in preserving the spleen and avoiding splenectomy.

The procedure had a relatively low complication rate, with 41% of patients experiencing complications, primarily left pleural effusion, and no reported mortality, suggesting it is a safe adjunctive treatment for managing splenic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early embolization in the non-operative management of blunt splenic injuries: a retrospective multicenter study]. Brugère, C., Arvieux, C., Dubuisson, V., et al.[2022]

The Amplatzer Vascular Plug (AVP) demonstrated precise deployment and resistance to migration in proximal splenic artery embolization (SAE), with successful use in 18 out of 18 cases, compared to 31.8% migration in coil procedures.

AVP procedures resulted in a significantly lower radiation dose (842 mGy) compared to coils (1,309 mGy), making it a safer option in terms of radiation exposure, although the need for additional embolic material may limit its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the Amplatzer Vascular Plug in splenic artery embolization: a comparison study with conventional coil technique. Zhu, X., Tam, MD., Pierce, G., et al.[2011]

The Cera vascular plug, delivered through the innovative FuStar steerable introducer sheath, demonstrated improved safety and efficacy in a pig model, resulting in shorter fluoroscopy times and reduced contrast medium usage compared to a control introducer.

At a 2-month follow-up, the Cera plug showed persistent occlusion in 18 out of 20 target vessels without migration, although organ ischemia was noted in one case, indicating the importance of proper placement within the target vessel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel endovascular occlusion device with a steerable introducer for embolization in a porcine model. Lu, W., Fu, W., Si, Y., et al.[2016]

In a meta-analysis of eight studies involving 133 patients, vascular plugs were found to achieve faster vessel occlusion times (7.11 minutes quicker) and required fewer devices compared to coil embolization for splenic artery procedures.

Patients treated with vascular plugs experienced significantly less radiation exposure (439 mGy less) and shorter fluoroscopy times (13.82 minutes shorter), indicating a safer profile for this method compared to coils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of Intraprocedural Comparative Effectiveness of Vascular Plugs Vs Coils in Proximal Splenic Artery Embolization and Associated Patient Radiation Exposure. Johnson, P., Wong, K., Chen, Z., et al.[2022]

In a study involving 14 patients, the Amplatzer vascular plug (AVP) was successfully used for precise proximal splenic artery embolization, demonstrating effective placement and occlusion without complications.

The procedure achieved occlusion in an average of 10 minutes, and follow-up CT scans confirmed no device migration or recanalization, indicating the safety and efficacy of the AVP for splenic salvage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Amplatzer vascular plug for proximal splenic artery embolization. Widlus, DM., Moeslein, FM., Richard, HM.[2019]

The study successfully enrolled 46 out of 50 eligible patients (92%) in a randomized controlled trial comparing endovascular coils (EC) and vascular plugs (VP) for treating high-grade splenic trauma, indicating that such trials are feasible.

Both EC and VP demonstrated excellent splenic salvage rates of 98%, with primary technical success rates suggesting a higher likelihood of success for EC compared to VP, while complications were low for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of endovascular coils and vascular plugs for proximal splenic artery embolization in high-grade splenic trauma. Gunn, AJ., Raborn, JR., Griffin, R., et al.[2021]

Splenic artery embolization (SAE) was successfully performed on a 52-year-old male with a grade IV splenic injury and significant cardiac issues, demonstrating its effectiveness as a life-saving intervention in complex cases.

Despite the patient's unstable cardiac condition and anticoagulant therapy, the procedure was well-tolerated, allowing for a quick recovery and discharge just three days post-embolization, highlighting the safety and efficacy of SAE in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of a delayed, post-traumatic rupture of splenic artery pseudoaneurysm in a patient with life threatening co-morbidities: A treatment challenge. Kumari, M., Parwez, M., Jain, A., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9832195/

Proximal splenic artery embolization using a vascular plug ... Overall mortality of the patients was 2.6% (2/76 patients), with one patient succumbing to other injuries not related to their splenic trauma.

2. jvir.org jvir.org/article/S1051-0443(18)32107-9/fulltext

03:18 PM Abstract No. 250 Meta-analysis of ... The vascular plug appears to be superior to coils in embolization of proximal splenic artery with respect to time to occlusion, fluoroscopy time, patient ...

3. jtraumainj.org jtraumainj.org/journal/view.php?number=1334

Splenic artery embolization for trauma: a narrative review SAE has demonstrated a success rate exceeding 90% in controlling splenic hemorrhage in trauma settings [1,15,38,42,43,45,51,52]. Complication ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05128955

Embolization of the Splenic Artery After Trauma Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211568418301487

Proximal embolization of splenic artery in acute trauma ... The efficacy rate of proximal splenic embolization with POD® and AVP was 100% without additional embolization and 89% using coils (one splenectomy was necessary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8049757/

Splenic Artery Embolization for Patients with High-Grade ... The purpose of this article is to review the indications, technical aspects, and clinical outcomes of splenic artery embolization for patients with high-grade ...

7. cvirendovasc.springeropen.com cvirendovasc.springeropen.com/articles/10.1186/s42155-022-00345-8

Proximal splenic artery embolization using a vascular plug in ... The main purpose of this study was to retrospectively assess if proximal SAE with a vascular plug alone is effective in stopping bleeding and achieving splenic ...