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NCT05008172 · ClinicalTrials.gov registry record · NA
Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial
A NA study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT05008172 is a NA study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 3 participants.
The verdict
NCT05008172, a NA study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
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.
Interventions
- PROCEDURE Splenic Artery Embolization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05008172
The ClinicalTrials.gov registry entry for NCT05008172 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Splenic Artery Embolization is the first listed.
NCT05008172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05008172 about?
NCT05008172 is a clinical study titled "Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial". 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. ...
What is the current status of trial NCT05008172?
This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2021-09-01. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT05008172?
The interventions under investigation include: Splenic Artery Embolization (PROCEDURE).
Who is sponsoring clinical trial NCT05008172?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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