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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06336889
Enrollment
400
Registered
2024-03-29
Start date
2017-10-26
Completion date
2024-10-31
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Hemorrhage

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.

Interventions

PROCEDUREPelvic 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.

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality outcome2018-2019Dead or Alive
transfusion requirements2018-2019transfusion requirements
thromboembolic events2018-2019thromboembolic events

Secondary

MeasureTime frameDescription
Patient demographics(age, sex)2018-2019Patient demographics

Countries

United States

Contacts

Primary ContactCrystee Cooper, DHEd
clinicalresearch@mhd.com214-947-1280
Backup ContactZaid Haddadin, MS
clinicalresearch@mhd.com214-947-1280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026