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Embolization vs Observation for Spleen Injury

N/A

Recruiting

Led By Thomas Carver, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing whether or not surgery is better than non-operative management for high grade blunt splenic injuries.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of Splenic Artery Embolization include pain at the catheter insertion site, allergic reaction to contrast dye used in imaging during the procedure, damage to blood vessels or nerves near the spleen, and complications related to reduced blood supply to the spleen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe spleen injury with significant internal bleeding.

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

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I am 18 years old or older.

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My spleen injury is severe.

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I have an injury to my spleen caused by a blunt force.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Failure of nonoperative management

Secondary outcome measures

Complication rates

Procedural complications for SAE Arm

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Splenic Artery Embolization (SAE)Experimental Treatment1 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: ObservationActive Control1 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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,633 Total Patients Enrolled

Thomas Carver, MDPrincipal InvestigatorMedical College of Wisconsin

1 Previous Clinical Trials

130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this trial?

"Affirmative. Clinicaltrials.gov information reveals that this trial, which debuted on September 1st 2021, is actively recruiting patients for participation. 80 individuals must be sourced from a solitary medical site."

Answered by AI

Is this research endeavor actively seeking participants?

"Yes, the information on clinicaltrials.gov confirms that this trial is still open for recruitment. It was initially announced on September 1st 2021 and has since been modified multiple times, with its last update being November 12th 2021. The research team needs to enlist 80 people from a single site in order to conduct the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Thomas Carver 2021. "Observation vs Embolization in Severe Splenic Injury: A Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05008172.