Embolization vs Observation for Spleen Injury

Overseen By Margo Mantz-Wichman, BS RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Hemodynamic instability, Severe TBI, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether splenic artery embolization (SAE), a procedure that blocks blood flow to the spleen, is more effective than observation for individuals with serious spleen injuries. The goal is to determine if SAE can prevent the failure of non-surgical management in these cases. Participants include those who have experienced a blunt spleen injury with significant internal bleeding or damage visible on scans. As an unphased trial, it offers participants the chance to contribute to medical knowledge and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that splenic artery embolization is safe for managing splenic injuries?

Research has shown that Splenic Artery Embolization (SAE) is generally safe and effective. Studies indicate it successfully stops bleeding from the spleen after an injury in over 90% of cases. However, some risks exist. One study found that about 25% of patients experienced complications, with approximately 9.6% requiring additional procedures, such as spleen removal.

While SAE effectively controls bleeding, there is a chance of needing further treatment or facing complications. These factors are important to consider when deciding to join a clinical trial for this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Splenic Artery Embolization (SAE) for spleen injuries because it offers a minimally invasive alternative to traditional surgery. Unlike surgical removal of the spleen, which can lead to significant recovery time and potential complications, SAE targets the blood vessels directly to control bleeding, preserving the spleen and its immune functions. This technique can be performed relatively quickly, within 6-12 hours of injury, providing timely intervention while reducing the need for more invasive procedures.

What evidence suggests that splenic artery embolization is effective for decreasing NOM failure in high grade splenic injuries?

Research has shown that Splenic Artery Embolization (SAE), one of the treatments studied in this trial, effectively treats serious spleen injuries. Studies have found that SAE stops bleeding in over 90% of trauma cases. In one study, the procedure succeeded every time, with only about 9.6% of patients requiring surgery afterward. Although some complications can occur, SAE is generally considered a safe and effective alternative to surgery. This treatment blocks blood flow to the spleen, potentially avoiding more invasive procedures. Participants in this trial will be randomized to receive either SAE or observation. ^{1 2 3 6 7}

Who Is on the Research Team?

Thomas Carver, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain types of severe spleen injuries from blunt trauma. They must show specific signs on a CT scan, like contrast blush or pseudoaneurysm, and not require immediate surgery for other injuries. Excluded are those with severe brain injury, kidney disease not on dialysis, pregnant women, prisoners, or unstable vital signs upon hospital arrival.

Inclusion Criteria

I have a severe spleen injury with significant internal bleeding.

My injury is severe with specific signs on a CT scan or angiography.

My spleen injury is severe.

Exclusion Criteria

I have had a severe brain injury.

I am unable to give consent by myself.

I cannot have angioembolization due to severe contrast allergy or chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to either Splenic Artery Embolization (SAE) or Observation. SAE is performed within 6-12 hours of enrollment for those in the SAE arm.

1 day

1 visit (in-person)

Monitoring

Participants in the observation arm are monitored in the ICU or trauma floor for continuous care.

30 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of procedural complications and overall outcomes.

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Splenic Artery Embolization

Trial Overview The study compares two approaches to treating serious spleen injuries: just watching the patient carefully (observation) versus using a procedure called Splenic Artery Embolization (SAE), which blocks blood flow to damaged areas of the spleen to prevent bleeding.

How Is the Trial Designed?

Group I: Splenic Artery Embolization (SAE) Experimental Treatment 1 Intervention

If a patient is randomized to the SAE arm, the Interventional Radiology (IR) team will be notified of the patient's enrollment. The timing of embolization is left to the IR team but will occur within 6-12 hours of enrollment.

Group II: Observation Active Control 1 Intervention

Patients assigned to the observation arm will be transferred from the trauma bay to floor or the ICU for monitoring and continuous care under the Trauma team.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38824852/

Clinical Outcomes of Splenic Artery Embolization Versus ... This study aims to compare the outcomes of splenic artery embolization (SAE) versus splenectomy in adult trauma patients with high-grade blunt splenic injuries.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12470969/

Real-World Outcomes of Splenic Artery Embolization in Blunt ... Results: The technical success rate was 100%, with a 9.6% rate of post-embolization splenectomy and a complication rate of 24.9% (including 5.7% ...

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. nature.com nature.com/articles/s41598-024-59420-w

Comparative effectiveness of angioembolization versus ... The effectiveness and safety of transcatheter splenic artery embolization (SAE) compared to those of open surgery in patients with blunt splenic injury (BSI) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424002671

Clinical Outcomes of Splenic Artery Embolization Versus ... This study aims to compare the outcomes of splenic artery embolization (SAE) versus splenectomy in adult trauma patients with high-grade blunt splenic injuries.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6710021/

Outcomes Following Blunt Traumatic Splenic Injury Treated ... There were no treatment failures in the embolization group. In the observation group, there were 19 treatment failures for an overall failure rate of 11.2%.

7. dirjournal.org dirjournal.org/articles/splenic-artery-embolization-in-the-treatment-of-blunt-splenic-injury-single-level-1-trauma-center-experience/dir.2024.242789

Splenic artery embolization in the treatment of blunt ... The endovascular management of BSI is safe and effective. The overall splenic salvage rate was 90.3%. Distal embolization with Gelfoam®was not associated with ...