Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography (Echo-TC)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Other: Transthoracic echocardiography on TBI patients; Other: Transthoracic echocardiography on control patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02380482

Echo-TC

Details and patient eligibility

About

Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

TBI patients

Inclusion Criteria:

• Isolated and non opened traumatic brain injury
• 18 - 65 years old
• Intubated and mechanically ventilated
• Glasgow score < or = 9 or
• Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
• Medical insurance

Exclusion Criteria:

• Treated major cardiovascular risks factors
• cardiovascular past medical history (acute cardiovascular event)
• Cardio thoracic surgery
• Brain dead status
• Inotrope drugs
• Severe polytraumatism
• Acute haemorrhage
• Non echogenic patient
• High level athlete
• Incapacitated person by law and pregnant women
• Discovery during echocardiography of underlying cardiomyopathy
• Urgent neurosurgery required

Control patients

Inclusion Criteria:

• Isolated and non opened traumatic brain injury
• 18 - 65 years old
• Intubated and mechanically ventilated
• Paired with TBI patient on age, BMI and sex
• Undergoing urgent non severe surgery
• Medical insurance

Exclusion Criteria:

• Traumatic brain injury
• Treated major cardiovascular risks factors
• cardiovascular past medical history (acute cardiovascular event)
• Cardio thoracic surgery
• Inotrope and vasopressive drugs
• Circulatory failure
• Non echogenic patient
• High level athlete
• Incapacitated person by law and pregnant women
• Discovery during echocardiography of underlying cardiomyopathy
• Urgent neurosurgery required

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Traumatic brain injury

Other group

Description:

Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients * Glasgow score \< or = 9 or * Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages: diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries

Treatment:

Other: Transthoracic echocardiography on TBI patients

Controls

Other group

Description:

Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria: * Intubated and mechanically ventilated * Undergoing urgent non severe surgery

Treatment:

Other: Transthoracic echocardiography on control patients