Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT06336889

Conditions

Pelvic Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic Angioembolization

Study Details

Brief summary:

The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization.

Conditions

Pelvic Hemorrhage

Study ID

NCT06336889

Start date

Oct 26, 2017

Status verified date

Mar, 2024

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • All blunt trauma patients undergoing angiography for pelvic fracture associated hemorrhage

Exclusion Criteria:

  • • Pregnant patients

  • Patients < 18 years old
  • Patients undergoing angiography greater than 24 hours from arrival

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

Pelvic Angioembolization

Embolization is performed by placing a small catheter inside the blood vessels that supply the area that is bleeding. Carefully navigating the catheter, under image guidance, to the safest and farthest point, a variety of different materials can then be used to block the bleeding vessels.

Primary outcome measure

  • Mortality outcome [ Time Frame: 2018-2019 ]
  • transfusion requirements [ Time Frame: 2018-2019 ]
  • thromboembolic events [ Time Frame: 2018-2019 ]

Central Contacts and Locations

Central contacts

Crystee Cooper, DHEd

214-947-1280clinicalresearch@mhd.com

Zaid Haddadin, MS

214-947-1280clinicalresearch@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75201

Contacts

Jennifer Burris, MD

214-947-1280clinicalresearch@mhd.com

More Information

Sponsor

Methodist Health System

Last update posted

Mar 29, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-03-29.