RECRUITING

Embolization of the Splenic Artery After Trauma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-10
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05128955

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.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥15 years of age
  2. 2. Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT
  3. 3. Splenic injury to be treated by non-operative management as decided by attending trauma surgeon and interventional radiologist
  4. 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. 1. Inability to obtain informed consent
  2. 2. ≤ 50kg
  3. 3. Uncorrectable coagulopathy
  4. 4. Patient is immunocompromised
  5. 5. Pregnant
  6. 6. Breast-feeding
  7. 7. Non-English speakers
  8. 8. Prisoners

Contacts and Locations

Study Contact

April Riddle, BS
CONTACT
2059346504
ariddle@uabmc.edu
Evan Hudson, BS
CONTACT
2059346499
evanhudson@uabmc.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Prisma Health
Greenville, South Carolina, 29615
United States
The University of Texas Health Science Center at Houston McGovern Medical School
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Andrew J. Gunn

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-10
Study Completion Date2025-04

Study Record Updates

Study Start Date2022-05-10
Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

  • High-grade Splenic Injuries