Splenic Artery Embolization for Spleen Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Froedtert Hospital, Milwaukee, WI
Spleen Injury+1 More
Splenic Artery Embolization - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial

See full description

Eligible Conditions

  • Spleen Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Splenic Artery Embolization will improve 1 primary outcome and 2 secondary outcomes in patients with Spleen Injury. Measurement will happen over the course of 30 days.

30 days
Complication rates
Failure of nonoperative management
Procedural complications for SAE Arm

Trial Safety

Trial Design

2 Treatment Groups

Observation
1 of 2
Splenic Artery Embolization (SAE)
1 of 2
Active Control
Experimental Treatment

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Splenic Artery Embolization is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Splenic Artery Embolization (SAE)
Procedure
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.
ObservationPatients 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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days for reporting.

Who is running the study

Principal Investigator
T. C.
Prof. Thomas Carver, Associate Professor
Medical College of Wisconsin

Closest Location

Froedtert Hospital - Milwaukee, WI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
AAST Grade 4 and 5 spleen injuries regardless of the presence of blush
Patients with blunt splenic injury.
Age ≥ 18 years old
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

Patient Q&A Section

What are common treatments for wounds?

"Wounds are treated differently from skin lesions, especially as wounds related to diabetes. The mainstay of therapy for a wound is surgical debridement. Further assessment is provided with an appropriate dressing and antiseptic application." - Anonymous Online Contributor

Unverified Answer

How many people get wounds a year in the United States?

"It is estimated that wounds affect over 100 million US adults each year. This leads to the greatest burden for this nation's health care system." - Anonymous Online Contributor

Unverified Answer

What are the signs of wounds?

"It can be concluded from the signs that the wound has been made as a result of trauma (e.g. gunshot or spear wound). The wound-site can also be palpated for swollen tissue. In a penetrating wound the patient may complain of pain and/or swelling. The severity and progress of a wound can be predicted on the basis of these signs of traumas." - Anonymous Online Contributor

Unverified Answer

What is wounds?

"Wounds are the most common skin manifestations occurring in patients with IBD. Patients with IBD suffer from severe dermatitis or stomatitis. For both lesions, the treatment is usually ineffective and must be repeated several times. Moreover, chronic wounds are more frequent in this group of patients." - Anonymous Online Contributor

Unverified Answer

Can wounds be cured?

"No treatment will prevent wounds and all wound treatments are symptomatic. The main goals of wound care are to reduce pain and discomfort (i.e. wound dehiscence, breakdown of the skin and infection) and to allow the underlying healing to progress. Treatment that reduces the chance of wound dehiscence by minimizing postoperative pain and discomfort and by improving wound healing will reduce wound breakdown. Similarly, the aim of wound healing will be achieved when these goals are achieved." - Anonymous Online Contributor

Unverified Answer

What causes wounds?

"Wounds present in different ways dependent on the location in the body but are more likely to grow and become infected if they have a slow rate of healing (such as in diabetes). The process of wound healing involves multiple interacting processes, in which several types of cells must cooperate. These include vascular endothelial cells, which are the cells responsible for wound healing, to form a sealing plug through the breakdown of blood plasma in order to prevent blood loss and tissue atrophy. Wound healing is also an active process that occurs in order to repair the damaged tissue. Wound healing can be divided into three phases, each with varying rates of repair." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for wounds?

"There are no randomized controlled trials demonstrating whether wounds can be healed by any alternative therapy or not. The most important consideration is to decide whether healing is better with alternative therapies or usual care. A combination of the best evidence, the clinical trials and other studies, should be used in the decision-making process. Clinical trials are needed for the management of diabetic foot infections and other chronic wounds. Wounds should not be excluded from clinical trials because they cannot be self-resolved." - Anonymous Online Contributor

Unverified Answer

Does splenic artery embolization improve quality of life for those with wounds?

"Patients with active liver disease who had been hospitalized for wounds that were not adequately treated with antibiotics and/or surgery had significantly improved physical and mental QoL after an emergency SAE procedure, compared to those without active liver disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating wounds?

"Most important developments in wound care have probably been happening in the past few decades, despite few studies being carried out. A key area for the future involves the improvement of wound healing with the intention of reducing the occurrence of wound breakdown by optimizing the quality of the wound. The discovery in 1998 of two genes with high and low expression levels in a developing rat's skin led to studies in 2005 as well as one study published in 2016 to evaluate these new genes in improving wound healing and the discovery that an effective therapy that may be trialled on patients by injecting the desired gene into skin is feasible. More work is necessary to evaluate its efficacy and to assess safety for both clinical trials and application." - Anonymous Online Contributor

Unverified Answer

How does splenic artery embolization work?

"The spleen is not the major organ involved in liver abscesses associated with splenic artery embolization because these complications are rare. This observation would be useful in the future in the decision-making for treating liver abscesses by splenic artery embolization." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of splenic artery embolization?

"Despite its significant role in treating portal hypertension, SAE may not always guarantee the optimal blood flow of the spleen. A lower spleen function and a longer time needed for the spleen to recover might compromise the functional and operative outcomes of SAE. Inadequate or delayed hemoglobin recovery may also affect the SAE outcome. Patients with multiple SAE will experience greater blood loss and longer operative times." - Anonymous Online Contributor

Unverified Answer

What is the latest research for wounds?

"The treatment of chronic wounds is the subject of ongoing research and clinical practice. Many effective methods have been documented and published over many years and are now recommended by expert clinical bodies and practice guidelines such as those published by the British Association for the Study of Wound Healing. Clinicians should always refer, where possible, to the most pertinent evidence available." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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