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

Recruiting

• Conditions: Pelvic Hemorrhage

• Registration Number: NCT06336889
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2017-10-26
• Study First Submitted: 2022-04-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
transfusion requirements	2018-2019	transfusion requirements
thromboembolic events	2018-2019	thromboembolic events
Mortality outcome	2018-2019	Dead or Alive

Secondary Outcome Measures

Name	Time	Method
Patient demographics(age, sex)	2018-2019	Patient demographics

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States