Analysis of Urogenital Injuries in Polytraumatized Patients

• Sponsor: Technische Universität München (Other)
• Overall Status: Completed
• CT.gov ID: NCT05074095
• Collaborator: (none)
• Enrollment: 500
• Actual Duration (Months): 61

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Polytrauma	Other: retrospective analysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Injuries of the Urogenital Tract in Polytraumatized Patients in Correlation With Injuries to the Spine and Pelvic Girdle- Are There Positive Predictive Factors
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with urogenital injuries	Other: retrospective analysis
2 Patients without urogenital injuries	Other: retrospective analysis

Outcome Measures

Primary Outcome Measures

1. Predictive factors for urogenital injuries [5 years]

   This retrospective analysis is designed to identify predictors of urogenital injuries in polytrauma patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Technische Universität München

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität München
• ClinicalTrials.gov Identifier: NCT05074095
• Other Study ID Numbers: 229/20 S-EB
• First Posted: Oct 12, 2021
• Last Update Posted: Oct 12, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Trauma

Study Results

No Results Posted as of Oct 12, 2021