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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Hemorrhage
• Intervention / Treatment: Procedure: Pelvic Angioembolization

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: ClinicalResearch@mhd.com
• Study Contact Backup: Name: Zaid Haddadin, MS; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75201
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Jennifer Burris, MD; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigator will ensure that this study is conducted in full conformity with the principles set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, as drafted by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979) and codified in 45 CFR Part 46 and/or the ICH E6. If the study is conducted at international sites, the statement could be as above and/or could reference compliance with the Declaration of Helsinki, CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002), or another country's ethical policy statement, whichever provides the most protection to human subjects.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality outcome	Dead or Alive	2018-2019
transfusion requirements	transfusion requirements	2018-2019
thromboembolic events	thromboembolic events	2018-2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient demographics(age, sex)	Patient demographics	2018-2019

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Jennifer Burris, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 092.TRA.2018.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No