Severe Head Trauma: Coagulation and CT-Scan Aggravation.

Head Trauma Clinical Trial

— TCA-COAG  

Official title:

Severe Head Trauma: Coagulation and CT-Scan Aggravation.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06246500
• Other study ID #: 18-43
• Status: Terminated
• Start date: May 11, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Trauma
• Wounds and Injuries

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Centre Hospitalier Annecy Genevois	Pringy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality rate	Day 28
Secondary	Causes of death	Causes of death	Day 28
Secondary	Describe the coagulation status on admission with severe head trauma trauma	Fibrinogen level values	24 hours
Secondary	Describe the coagulation status on admission with severe head trauma trauma	Platelet count values	24 hours
Secondary	Describe the coagulation status on admission with severe head trauma trauma	INR values	24 hours
Secondary	Describe the coagulation status on admission with severe head trauma trauma	ROTEM values	24 hours