Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used)

NCT ID: NCT06336889

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-26
• Study Completion Date: 2024-10-31

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.

Detailed Description

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. The investigator's will divide patients into groups based on positive or negative angiogram. Within each group the investigator's will compare those embolized and level of embolization. All blunt trauma patients undergoing angiography for pelvic fracture associated hemorrhage will be eligible for the study. Demographic, physiologic, operative, and post-operative data will be collected including blood product resuscitation, classification and management of pelvic fracture, associated injuries, angiographic details, complications, outcomes and overall injury burden. The study population will be stratified based on presence of arterial hemorrhage on initial angiogram (positive or negative angiogram) and then further stratified based on performance of embolization. NSE will be defined as embolization of the main internal iliac artery, either unilaterally or bilaterally and SE as any embolization distal to the main internal iliac artery. Bivariable and multivariable analyses will be performed to determine differences in pelvic hemorrhage as measured by transfusion necessity and quantity of products required, complications and to identify independent risk factors for outcome variables. A power analysis was performed based off of thromboembolic complication difference in selective vs. non selective embolization and then again with blood transfusion requirement difference in embolized vs. not embolized for those who have no evidence of arterial bleeding on angiogram (IE the two questions the investigator's are trying to answer).The investigator's plan to complete the data collection and analysis by 1/1/2019.

Conditions

Pelvic Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Burris, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Crystee Cooper, DHEd

Role: CONTACT

clinicalresearch@mhd.com

214-947-1280

Zaid Haddadin, MS

Role: CONTACT

clinicalresearch@mhd.com

214-947-1280

Facility Contacts

Jennifer Burris, MD

Role: primary

clinicalresearch@mhd.com

214-947-1280

Other Identifiers

092.TRA.2018.D

Identifier Type: -

Identifier Source: org_study_id