Severe Head Trauma: Coagulation and CT-Scan Aggravation. | NCT06246500

Studies
Severe Head Trauma: Coagulation and CT-Scan Aggravation.

NCT06246500

Sponsor

Centre Hospitalier Annecy Genevois

Status

Terminated

Last Update Posted

Feb 7, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Head Trauma

Interventions

No intervention

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment issue

Expanded Access Info

Start Date

May 11, 2021Actual

Primary Completion Date

Jul 8, 2021Actual

Completion Date

Jul 8, 2021Actual

First Submitted Date

Mar 2, 2021

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The objective of the study is to describe the evolution of CTscan lesions in patients with isolated Head Trauma between admission and re-evaluation after 24 hours.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality	Mortality rate	Day 28
Causes of death	Causes of death	Day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Annecy Genevois		Pringy		74374	France

Condition Browse Module

MeSH Terms

ID	Term
D006259	Craniocerebral Trauma

Ancestor Terms

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided