Analysis of Urogenital Injuries in Polytraumatized Patients

Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors

Urogenital injuries occur in approximately 5-10 % of all severly injured patients. The literature lacks a thorough investigation into the mechanisms of trauma, the analysis of the whole urogenital tract and especially the correlation of thoracic and lumbar spine and pelvic injuries with urogenital injuries.

The goal of this study is to provide a thorough investigation into these primary end points in a multicenter study of university hospitals in Germany.

Study Overview

• Status: Completed
• Conditions: Polytrauma
• Intervention / Treatment: Other: retrospective analysis

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective analysis of polytrauma patients.

Description

Inclusion Criteria:

• ISS (Injury severity score) > 15 points
• Patient Age > 16
• Fracture of the thoracic and/ or lumbar spine
• Fracture of the pelvic girdle
• at least one AIS (abbreviated injury scale) > 2

Exclusion Criteria:

• ISS < 16 points
• no fractures of the thoracic or lumbar spine or fractures of the pelvic girdle
• no AIS > 2
• patient age under 16 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients with urogenital injuries	Other: retrospective analysis
2; Patients without urogenital injuries	Other: retrospective analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors for urogenital injuries	This retrospective analysis is designed to identify predictors of urogenital injuries in polytrauma patients	5 years

Collaborators and Investigators

• Sponsor: Technical University of Munich

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (ACTUAL): October 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: 229/20 S-EB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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