Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial (NCT05008172) | Clinical Trial Compass
CompletedNot Applicable
Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial
United States3 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. AAST Grade 4 and 5 spleen injuries regardless of the presence of blush
Exclusion criteria
✕. Hemodynamic instability on arrival at the hospital
✕. Patients undergoing immediate surgical exploration for splenic or other intra-abdominal injuries
✕. Patients with non-contrast CT scan of the abdomen
✕. Patients undergoing angioembolization for other injuries
✕. Patients with severe traumatic brain injury (GCS 8 or less)