Embolization of the Splenic Artery After Trauma

Description

Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.

Conditions

High-grade Splenic Injuries

Talk to us

Study Overview

On this page

Study Details

Study overview

Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.

Embolization of the Splenic Artery After Trauma (ELSA-2)

Embolization of the Splenic Artery After Trauma

Condition
High-grade Splenic Injuries
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Winston-Salem

Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States, 27157

Columbus

Ohio State University Medical Center, Columbus, Ohio, United States, 43210

Greenville

Prisma Health, Greenville, South Carolina, United States, 29615

Houston

The University of Texas Health Science Center at Houston McGovern Medical School, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. ≥15 years of age
  • 2. Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT
  • 3. Splenic injury to be treated by non-operative management as decided by attending trauma surgeon and interventional radiologist
  • 4. The attending interventional radiologist determines that the patient will undergo proximal splenic artery embolization with the specific method to be decided by randomization.
  • 1. Inability to obtain informed consent
  • 2. ≤ 50kg
  • 3. Uncorrectable coagulopathy
  • 4. Patient is immunocompromised
  • 5. Pregnant
  • 6. Breast-feeding
  • 7. Non-English speakers
  • 8. Prisoners

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Andrew J. Gunn,

Study Record Dates

2025-04