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Completed

NCT Number: NCT02380482

Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transthoracic echocardiography on TBI patients

Other

Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma

Transthoracic echocardiography on control patients

Other

Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated

Primary outcomes

  1. left ventricular ejection fraction

    Time frame: within the first 24 hours after injury

Secondary outcomes

  1. Strain evaluation by speckle tracking (in percentage of systolic duration)

    Time frame: within the first 24 hours after injury

  2. Systolic strain rate by speckle tracking (in second)

    Time frame: within the first 24 hours after injury

  3. Diastolic strain rate by speckle tracking (in second)

    Time frame: within the first 24 hours after injury

  4. Systolic rotational velocity by speckle tracking (in degree by second)

    Time frame: within the first 24 hours after injury

  5. Diastolic rotational velocity by speckle tracking (in degree by second)

    Time frame: within the first 24 hours after injury

  6. Systolic twisting velocity by speckle tracking (in degree by second)

    Time frame: within the first 24 hours after injury

  7. Diastolic untwisting velocity by speckle tracking (in degree by second)

    Time frame: within the first 24 hours after injury

  8. Myocardial wall thickness (in millimeter)

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

  9. left ventricular diastolic function (cm/sec)

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

  10. Cardiac index

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

  11. tissue doppler imaging (cm/sec)

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

  12. right ventricular diastolic function

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

  13. right ventricular systolic function

    Time frame: within the first 24 hours after injury

    2D transthoracic echography

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: Echo-TC

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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