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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Transthoracic echocardiography on TBI patients; Other: Transthoracic echocardiography on control patients

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Traumatic brain injury; 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	Other: Transthoracic echocardiography on TBI patients; Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma
Other: Controls; 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	Other: Transthoracic echocardiography on control patients; Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
left ventricular ejection fraction	within the first 24 hours after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strain evaluation by speckle tracking (in percentage of systolic duration)		within the first 24 hours after injury
Systolic strain rate by speckle tracking (in second)		within the first 24 hours after injury
Diastolic strain rate by speckle tracking (in second)		within the first 24 hours after injury
Systolic rotational velocity by speckle tracking (in degree by second)		within the first 24 hours after injury
Diastolic rotational velocity by speckle tracking (in degree by second)		within the first 24 hours after injury
Systolic twisting velocity by speckle tracking (in degree by second)		within the first 24 hours after injury
Diastolic untwisting velocity by speckle tracking (in degree by second)		within the first 24 hours after injury
Myocardial wall thickness (in millimeter)	2D transthoracic echography	within the first 24 hours after injury
left ventricular diastolic function (cm/sec)	2D transthoracic echography	within the first 24 hours after injury
Cardiac index	2D transthoracic echography	within the first 24 hours after injury
tissue doppler imaging (cm/sec)	2D transthoracic echography	within the first 24 hours after injury
right ventricular diastolic function	2D transthoracic echography	within the first 24 hours after injury
right ventricular systolic function	2D transthoracic echography	within the first 24 hours after injury

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Publications and helpful links

General Publications

• Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
• Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015.
• Bahloul M, Chaari AN, Kallel H, Khabir A, Ayadi A, Charfeddine H, Hergafi L, Chaari AD, Chelly HE, Ben Hamida C, Rekik N, Bouaziz M. Neurogenic pulmonary edema due to traumatic brain injury: evidence of cardiac dysfunction. Am J Crit Care. 2006 Sep;15(5):462-70.
• Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, Fleisher LA, Froehlich JB, Gusberg RJ, Leppo JA, Ryan T, Schlant RC, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology; American Heart Association. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). J Am Coll Cardiol. 2002 Feb 6;39(3):542-53. doi: 10.1016/s0735-1097(01)01788-0. No abstract available. Erratum In: J Am Coll Cardiol. 2006 Jun 6;47(11):2356.
• Moussouttas M, Lai EW, Khoury J, Huynh TT, Dombrowski K, Pacak K. Determinants of central sympathetic activation in spontaneous primary subarachnoid hemorrhage. Neurocrit Care. 2012 Jun;16(3):381-8. doi: 10.1007/s12028-012-9673-5.
• Prathep S, Sharma D, Hallman M, Joffe A, Krishnamoorthy V, Mackensen GB, Vavilala MS. Preliminary report on cardiac dysfunction after isolated traumatic brain injury. Crit Care Med. 2014 Jan;42(1):142-7. doi: 10.1097/CCM.0b013e318298a890.
• Rosenthal G, Hemphill JC 3rd, Sorani M, Martin C, Morabito D, Obrist WD, Manley GT. Brain tissue oxygen tension is more indicative of oxygen diffusion than oxygen delivery and metabolism in patients with traumatic brain injury. Crit Care Med. 2008 Jun;36(6):1917-24. doi: 10.1097/CCM.0b013e3181743d77.
• Schrader H, Hall C, Zwetnow NN. Effects of prolonged supratentorial mass expansion on regional blood flow and cardiovascular parameters during the Cushing response. Acta Neurol Scand. 1985 Sep;72(3):283-94. doi: 10.1111/j.1600-0404.1985.tb00872.x.
• Shanlin RJ, Sole MJ, Rahimifar M, Tator CH, Factor SM. Increased intracranial pressure elicits hypertension, increased sympathetic activity, electrocardiographic abnormalities and myocardial damage in rats. J Am Coll Cardiol. 1988 Sep;12(3):727-36. doi: 10.1016/s0735-1097(88)80065-2.
• Shivalkar B, Van Loon J, Wieland W, Tjandra-Maga TB, Borgers M, Plets C, Flameng W. Variable effects of explosive or gradual increase of intracranial pressure on myocardial structure and function. Circulation. 1993 Jan;87(1):230-9. doi: 10.1161/01.cir.87.1.230.
• Song HS, Back JH, Jin DK, Chung PW, Moon HS, Suh BC, Kim YB, Kim BM, Woo HY, Lee YT, Park KY. Cardiac troponin T elevation after stroke: relationships between elevated serum troponin T, stroke location, and prognosis. J Clin Neurol. 2008 Jun;4(2):75-83. doi: 10.3988/jcn.2008.4.2.75. Epub 2008 Jun 20.
• Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with traumatic brain injury, 1979 through 1992. Success and failure. JAMA. 1995 Jun 14;273(22):1778-80.
• Cuisinier A, Maufrais C, Payen JF, Nottin S, Walther G, Bouzat P. Myocardial function at the early phase of traumatic brain injury: a prospective controlled study. Scand J Trauma Resusc Emerg Med. 2016 Oct 28;24(1):129. doi: 10.1186/s13049-016-0323-3.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Traumatic brain injury; Speckle tracking; Transthoracic echocardiography; Myocardial dysfunction
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Echo-TC