Embolization vs Observation for Spleen Injury

Overseen By Margo Mantz-Wichman, BS RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to determine if blocking blood flow to injured parts of the spleen helps patients with severe spleen injuries heal better, especially those at high risk of complications.

Research Team

Thomas Carver, MD

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

This trial is for adults over 18 with certain types of severe spleen injuries from blunt trauma. They must show specific signs on a CT scan, like contrast blush or pseudoaneurysm, and not require immediate surgery for other injuries. Excluded are those with severe brain injury, kidney disease not on dialysis, pregnant women, prisoners, or unstable vital signs upon hospital arrival.

Inclusion Criteria

I have a severe spleen injury with significant internal bleeding.

My injury is severe with specific signs on a CT scan or angiography.

I am 18 years old or older.

Exclusion Criteria

I have had a severe brain injury.

I am unable to give consent by myself.

Hemodynamic instability on arrival at the hospital

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to either Splenic Artery Embolization (SAE) or Observation. SAE is performed within 6-12 hours of enrollment for those in the SAE arm.

1 day

1 visit (in-person)

Monitoring

Participants in the observation arm are monitored in the ICU or trauma floor for continuous care.

30 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of procedural complications and overall outcomes.

30 days

Treatment Details

Interventions

• Splenic Artery Embolization

Trial Overview The study compares two approaches to treating serious spleen injuries: just watching the patient carefully (observation) versus using a procedure called Splenic Artery Embolization (SAE), which blocks blood flow to damaged areas of the spleen to prevent bleeding.

Participant Groups

Group I: Splenic Artery Embolization (SAE) Experimental Treatment 1 Intervention

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.

Group II: Observation Active Control 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+