NCT05074095

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

September 29, 2021

Last Update Submit

October 11, 2021

Conditions

Polytrauma

Outcome Measures

Primary Outcomes (1)

  • Predictive factors for urogenital injuries

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

    5 years

Study Arms (2)

1

Patients with urogenital injuries

Other: retrospective analysis

2

Patients without urogenital injuries

Other: retrospective analysis

Interventions

retrospective analysisOTHER
12

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Retrospective analysis of polytrauma patients.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

February 1, 2021

Last Updated

October 12, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share