NCT06246500

Brief Summary

Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
Last Updated

February 7, 2024

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

March 2, 2021

Last Update Submit

February 6, 2024

Conditions

Head Trauma

Outcome Measures

Primary Outcomes (1)

  • Describe the evolution of CT scan lesions between admission and reassessment CT scan

    Number of patient with an aggravation of lesions on CT scan

    24 hours

Secondary Outcomes (6)

  • Mortality

    Day 28

  • Causes of death

    Day 28

  • Describe the coagulation status on admission with severe head trauma trauma

    24 hours

  • Describe the coagulation status on admission with severe head trauma trauma

    24 hours

  • Describe the coagulation status on admission with severe head trauma trauma

    24 hours

  • +1 more secondary outcomes

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient data will be selected retrospectively and consecutively according to in and exclusion criteria. All patient admitted in emergency room between January 2016 and December 2018 severe head injury defined

You may qualify if:

  • Adults
  • Patients informed and did not object to the collection of their medical data for the study
  • Patient admitted in Trauma center between January 2016 and December 2018 severe head injury defined by a Glasgow Coma Scale (GCS) \< 9 AND/OR Abnormalities on the first brain CT-scan with pathological transcranial Doppler (Vd \< 25 cm/s and IP \> 1.25)

You may not qualify if:

  • Abbreviated Injury Score (AIS) head and neck ≤ 3 AND/OR AIS out of head and neck \> 3
  • Taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses;
  • Patients under guardianship
  • Patients still alive at the time of data collection AND opposed to the collection of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Annecy Genevois

Pringy, 74374, France

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

March 2, 2021

First Posted

February 7, 2024

Study Start

May 11, 2021

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

February 7, 2024

Record last verified: 2022-07

Locations

FR(1)