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

NCT05008172 | Completed

• 1 other identifier: PRO00040687
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blunt Splenic Injury; Nonoperative management; Splenic artery embolization

Outcome Measures

Primary Outcomes (3)

• Failure of nonoperative management

  Need for splenectomy

  30 days

• Failure of nonoperative management

  Need for splenorrhaphy

  30 days

• Failure of nonoperative management

  Unplanned SAE

  30 days

Secondary Outcomes (2)

• Complication rates

  30 days

• Procedural complications for SAE Arm

  30 days

Study Arms (2)

Splenic Artery Embolization (SAE)

EXPERIMENTAL

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.

Procedure: Splenic Artery Embolization

Observation

NO INTERVENTION

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.

Interventions

Splenic Artery Embolization PROCEDURE

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.

Splenic Artery Embolization (SAE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Thomas Carver, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the interventional nature of this study (embolization vs observation), it will not be possible to mask providers or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Once the attending surgeon decides on NOM the patient will be approached for enrollment by the ED Resuscitation Team. Randomization to prophylactic SAE vs observation will occur in block fashion.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 14, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)