Traumatic Brain InjuryEcho-TCNCT02380482
Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
A study testing Transthoracic echocardiography on TBI patients in people with Traumatic Brain Injury, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Transthoracic echocardiography on TBI patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Treated major cardiovascular risks factors
- cardiovascular past medical history (acute cardiovascular event)
- Cardio thoracic surgery
- Brain dead status
- Inotrope drugs
- Severe polytraumatism
Show all 24Show fewer
- 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
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Transthoracic echocardiography on TBI patients, Transthoracic echocardiography on control patients
- Keywords
- Traumatic brain injury, Myocardial dysfunction, Transthoracic echocardiography, Speckle tracking
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiography on TBI patientsOther
Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma
Transthoracic echocardiography on control patientsOther
Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated
| Study group | Role | What they receive |
|---|---|---|
| Traumatic brain injury | Other | 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 Receives: Other: Transthoracic echocardiography on TBI patients |
| Controls | Other | 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 Receives: Other: Transthoracic echocardiography on control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction
Measured: within the first 24 hours after injury
Secondary outcomes (13)
Strain evaluation by speckle tracking (in percentage of systolic duration)
Measured: within the first 24 hours after injury
Systolic strain rate by speckle tracking (in second)
Measured: within the first 24 hours after injury
Diastolic strain rate by speckle tracking (in second)
Measured: within the first 24 hours after injury
Systolic rotational velocity by speckle tracking (in degree by second)
Measured: within the first 24 hours after injury
Diastolic rotational velocity by speckle tracking (in degree by second)
Measured: within the first 24 hours after injury
Systolic twisting velocity by speckle tracking (in degree by second)
Measured: within the first 24 hours after injury
Diastolic untwisting velocity by speckle tracking (in degree by second)
Measured: within the first 24 hours after injury
Myocardial wall thickness (in millimeter)
2D transthoracic echography
Measured: within the first 24 hours after injury
left ventricular diastolic function (cm/sec)
2D transthoracic echography
Measured: within the first 24 hours after injury
Cardiac index
2D transthoracic echography
Measured: within the first 24 hours after injury
tissue doppler imaging (cm/sec)
2D transthoracic echography
Measured: within the first 24 hours after injury
right ventricular diastolic function
2D transthoracic echography
Measured: within the first 24 hours after injury
right ventricular systolic function
2D transthoracic echography
Measured: within the first 24 hours after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380482
- Sponsor's protocol ID
- Echo-TC
- Acronym
- Echo-TC
- Status last verified
- Dec 2015
- First submitted
- 23 Feb 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16926367Eagle 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.
PubMed 11823097Lang 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.
PubMed 16376782Mor-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.
PubMed 21338865Moussouttas 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.
PubMed 22311230Prathep 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.
PubMed 23963125Rosenthal 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.
PubMed 18496376Schrader 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.
PubMed 4061050Shanlin 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.
PubMed 3403832Shivalkar 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.
PubMed 8419012Song 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.
PubMed 19513307Sosin 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.
PubMed 7769773Cuisinier 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.
PubMed 27793208
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT02380482
- Acronym / sponsor ID
- Echo-TC / Echo-TC
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Myocardial dysfunction, Transthoracic echocardiography, Speckle tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury | Other | Other: Transthoracic echocardiography on TBI patientsTwo 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 |
| Controls | Other | Other: Transthoracic echocardiography on control patientsTwo 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- Treated major cardiovascular risks factors
- cardiovascular past medical history (acute cardiovascular event)
- Cardio thoracic surgery
- Brain dead status
- Inotrope drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiography on TBI patientsTwo Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma | Other | Traumatic brain injury |
| Transthoracic echocardiography on control patientsTwo Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated | Other | Controls |
Primary outcome
left ventricular ejection fraction
Time frame: within the first 24 hours after injury
13 secondary outcomes
Strain evaluation by speckle tracking (in percentage of systolic duration)
Time frame: within the first 24 hours after injury
Systolic strain rate by speckle tracking (in second)
Time frame: within the first 24 hours after injury
Diastolic strain rate by speckle tracking (in second)
Time frame: within the first 24 hours after injury
Systolic rotational velocity by speckle tracking (in degree by second)
Time frame: within the first 24 hours after injury
Diastolic rotational velocity by speckle tracking (in degree by second)
Time frame: within the first 24 hours after injury
Systolic twisting velocity by speckle tracking (in degree by second)
Time frame: within the first 24 hours after injury
Diastolic untwisting velocity by speckle tracking (in degree by second)
Time frame: within the first 24 hours after injury
Myocardial wall thickness (in millimeter)
Time frame: within the first 24 hours after injury
left ventricular diastolic function (cm/sec)
Time frame: within the first 24 hours after injury
Cardiac index
Time frame: within the first 24 hours after injury
tissue doppler imaging (cm/sec)
Time frame: within the first 24 hours after injury
right ventricular diastolic function
Time frame: within the first 24 hours after injury
right ventricular systolic function
Time frame: within the first 24 hours after injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Background: PubMed 16926367Bahloul 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.
- Background: PubMed 11823097Eagle 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.
- Background: PubMed 16376782Lang 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.
- Background: PubMed 21338865Mor-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.
- Background: PubMed 22311230Moussouttas 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.
- Background: PubMed 23963125Prathep 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.
- Background: PubMed 18496376Rosenthal 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.
- Background: PubMed 4061050Schrader 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.
- Background: PubMed 3403832Shanlin 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.
- Background: PubMed 8419012Shivalkar 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.
- Background: PubMed 19513307Song 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.
- Background: PubMed 7769773Sosin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiography on TBI patients in people with Traumatic Brain Injury, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction (time frame: within the first 24 hours after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380482, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.