Embolization vs Observation for Spleen Injury
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Monitoring
Participants in the observation arm are monitored in the ICU or trauma floor for continuous care.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of procedural complications and overall outcomes.
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
Citations
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.
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% ...
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 ...
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) ...
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.
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%.
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 ...
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