Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial
Completed · Not applicable
Conditions studied: Spleen Injury
In brief
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.
Key facts
- Study ID
- NCT05008172
- Run by
- Medical College of Wisconsin
- People needed
- 3
- Starts
- 2021-09-01
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2025-03-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- Patients who are unable to give consent
- Patients with contraindications for angioembolization (severe contrast allergy, chronic kidney disease (not on dialysis))
- Pregnancy
- Prisoners
Where it is running
- Froedtert Hospital — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.