What side effects are associated with this type of intervention?

Splenic Artery Embolization (SAE) is a procedure used to control bleeding in spleen injuries by reducing blood flow to the spleen. Common side effects of SAE include post-embolization syndrome, which is characterized by fever, pain, and nausea. There is also a risk of infection, splenic abscess, and infarction. Additionally, patients may experience complications related to the embolic material used, such as allergic reactions or migration of the material to other organs.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of spleen injury that directly mimic the mechanism of Splenic Artery Embolization (SAE). SAE itself is a procedural intervention rather than a pharmacological treatment. It involves the use of embolic agents to reduce blood flow to the spleen, thereby controlling bleeding and promoting clot formation. While various embolic materials and techniques are used in interventional radiology, these are procedural tools rather than drugs requiring FDA approval in the traditional sense.

What other types of research exist?

Promising novel alternatives to Splenic Artery Embolization (SAE) for spleen injury patients include: 1) Nonoperative management (NOM) with close monitoring and supportive care, which remains a standard approach for many splenic injuries. 2) Advanced imaging techniques and interventional radiology methods that enhance the precision of embolization or other minimally invasive procedures. 3) Use of hemostatic agents and sealants applied laparoscopically or via interventional radiology to control bleeding. 4) Development of bioengineered materials and devices designed to promote hemostasis and tissue regeneration. These alternatives aim to improve outcomes by reducing the need for invasive procedures, minimizing complications, and preserving splenic function.

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Embolization vs Observation for Spleen Injury

N/A

Recruiting

Led By Thomas Carver, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AAST Grade 3 spleen injuries with significant hemoperitoneum (2 or more areas of hemoperitoneum)

AAST Grade 3 with the presence of contrast blush or pseudoaneurysm on contrast CT scan or angiography

Must not have

Patients with severe traumatic brain injury (GCS 8 or less)

Patients who are unable to give consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if blocking blood flow to injured parts of the spleen helps patients with severe spleen injuries heal better, especially those at high risk of complications.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Splenic Artery Embolization include pain at the catheter insertion site, allergic reaction to contrast dye used in imaging during the procedure, damage to blood vessels or nerves near the spleen, and complications related to reduced blood supply to the spleen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe spleen injury with significant internal bleeding.

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

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I am 18 years old or older.

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My spleen injury is severe.

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I have an injury to my spleen caused by a blunt force.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a severe brain injury.

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I am unable to give consent by myself.

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

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I am receiving angioembolization for injuries not related to the trial.

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I am having surgery soon for injuries inside my belly, including my spleen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Failure of nonoperative management

Secondary study objectives

Complication rates

Procedural complications for SAE Arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Splenic Artery Embolization (SAE)Experimental Treatment1 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: ObservationActive Control1 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.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Splenic Artery Embolization (SAE) is a key treatment for spleen injuries, working by reducing blood flow to the spleen to control bleeding and promote clot formation. This is particularly important for spleen injury patients as it helps stabilize their condition while preserving spleen function, thus avoiding more invasive surgical procedures. Other treatments include nonoperative management (NOM), which involves monitoring and supportive care, and splenectomy, the surgical removal of the spleen, typically reserved for more severe cases. Each treatment is chosen based on the injury's severity and the patient's overall stability.

Splenic preservation after isolated splenic blunt trauma: The angioembolization paradox.