Severe Head Trauma: Coagulation and CT-Scan Aggravation. (TCA-COAG)

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.

Study Overview

• Status: Terminated
• Conditions: Head Trauma
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• France
  • Pringy, France, 74374
    • Centre Hospitalier Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate	Day 28
Causes of death	Causes of death	Day 28
Describe the coagulation status on admission with severe head trauma trauma	Fibrinogen level values	24 hours
Describe the coagulation status on admission with severe head trauma trauma	Platelet count values	24 hours
Describe the coagulation status on admission with severe head trauma trauma	INR values	24 hours
Describe the coagulation status on admission with severe head trauma trauma	ROTEM values	24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): July 8, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: 18-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No