Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336889
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2022-04-27
Brief Title:
Pelvic Angioembolization A Prospective Multi-Institutional Study Data From All Campuses Will be Used
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Pelvic Angioembolization A Prospective Multi-Institutional Study Data From All Campuses Will be Used
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators 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 investigators 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 investigators will divide patients into groups based on positive or negative angiogram Within each group the investigators 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 investigators are trying to answerThe investigators plan to complete the data collection and analysis by 112019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None