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

NCT05008172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-03-14

No results posted yet for this study

Summary

Nonoperative management (NOM) of blunt splenic injuries has been the standard of care for decades. While many splenic injuries can be successfully observed, studies have demonstrated increased failure rates for higher grade injuries, which prompted some institutions to perform SAE prophylactically. The current literature comparing observation and SAE is limited to observational data and is frequently inconsistent. As such, the standard of care varies across institutions and both strategies are considered acceptable management for splenic injuries. Our own institution does not routinely perform SAE and our splenic salvage rate exceed 90% but the investigators noted an increased rate of NOM failure in patients with a contrast blush on CT. Contrast blush is a known risk factor for NOM failure and has been cited as a reason to perform SAE, but even within this population no randomized trials have been performed to demonstrate if SAE improves outcomes. The purpose of this project is to provide definitive high-quality evidence for the effectiveness of SAE to decrease the rate of NOM failure in high grade splenic injuries.

Conditions

  • Spleen Injury

Interventions

PROCEDURE

Splenic Artery Embolization

The decision for proximal or distal (selective) embolization is at the discretion of the Interventional Radiologist. For patients with angiographically evident injury, the choice of embolization site will be left to the discretion of the operator. For patients without angiographically evident injury, proximal splenic embolization will be performed with approved materials (coils or plugs for most patients) within the main splenic artery. The embolization endpoint will be hemostasis in the main splenic artery.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Thomas Carver, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008172 on ClinicalTrials.gov