Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury

NCT01291706 | Completed

• 1 other identifier: DCIC 10 17
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 21

Brief Summary

Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.

Conditions

Traumatic Brain Injury

Keywords

Transcranial Doppler; Mild and moderate Traumatic Brain Injury; Neurological deterioration; Brain CT scan

Outcome Measures

Primary Outcomes (1)

• Negative predictive value of transcranial doppler

  Patient with mild to moderate traumatic brain injury (Glasgow Coma Scale 9-15) and a CT scan (TCDB II).TCD is performed within 8 hours after the trauma. Aggravation defined by: * a decrease in the Glasgow Coma Scale of 2 points or more from the initial value, in the absence of pharmacological sedation. * a neurological deterioration sufficient to warrant intervention: mechanical ventilation, sedation, osmotherapy, barbiturates, transfer to more intensive care, or neurosurgical intervention.

  within the first week after the injury

Secondary Outcomes (2)

• the impact of transcranial doppler for initial patient management

  within the first week after trauma

• Secondary neurological aggravation: risk factors and consequences.

  neurological outcome on D7 and D28

Study Arms (1)

Mild TBI with mild lesions on CT scan

Negative predictive value of transcranial doppler for patients with mild to moderate traumatic brain injury and mild brain lesions on initial CT scan (TCDB II)

Device: Transcranial Doppler

Interventions

Transcranial Doppler DEVICE

Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury

Mild TBI with mild lesions on CT scan

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary admission of patients following mild to moderate traumatic brain injury who need exploration with brain CT scan.

You may qualify if:

• years of age or more
• primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.
• with or without multiple injury.
• with no hemodynamic or respiratory distress: SAP \>90mmHg, SPO2 \>92%,hemoglobin \> 8 g/dl.
• with mild brain lesions on CTscan according to the traumatic coma data bank classification (TCDB) II: diffuse injury with cisterns present and no midline shift, mixed density lesions \<25 ml.
• Transcranial Doppler within 8 hours after the trauma.
• patient affiliated to the social security system or equivalent

You may not qualify if:

• Severe TBI (GCS\<9)
• Penetrating TBI
• patient with no brain CT scan
• patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)
• Hemodynamic or respiratory distress
• Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)
• previous intracranial surgery
• Patient with sedation and mechanical ventilation
• transcranial Doppler unable
• patient deprived of freedom by judicial or administrative decision
• Follow up at 7 days impossible
• Refusal consent to use data for statistics

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• CIC Clinical Investigation Centre Grenoble: collaborator

Study Sites (21)

CHRA Annecy

Annecy, Auvergne-Rhône-Alpes, 74000, France

Location

CHU Grenoble

Grenoble, Isere, 38043, France

Location

Ch Belley

Belley, France

Location

CHU

Besançon, France

Location

Ch Briancon

Briançon, France

Location

Ch Cannes

Cannes, France

Location

Ch Chambery

Chambéry, France

Location

CHU

Clermont-Ferrand, France

Location

CHU

Dijon, France

Location

Ch Grasse

Grasse, France

Location

Chu Edouard Herriot

Lyon, France

Location

CHU Lyon

Lyon, France

Location

CHU Pierre Benite

Lyon, France

Location

CH Nantes

Nantes, France

Location

Chu Nimes

Nîmes, France

Location

Ch Saint Jean de Maurienne

Saint-Jean-de-Maurienne, France

Location

Ch Saint Julien En Genevois

Saint-Julien-en-Genevois, France

Location

Hopitaux Du Pays Du Mont Blanc

Sallanches, France

Location

Ch Thonon Les Bains

Thonon-les-Bains, France

Location

CH Valence

Valence, France

Location

Ch Voiron

Voiron, France

Location

Related Publications (11)

• Thornhill S, Teasdale GM, Murray GD, McEwen J, Roy CW, Penny KI. Disability in young people and adults one year after head injury: prospective cohort study. BMJ. 2000 Jun 17;320(7250):1631-5. doi: 10.1136/bmj.320.7250.1631.

  PMID: 10856063 BACKGROUND

• Davis DP, Kene M, Vilke GM, Sise MJ, Kennedy F, Eastman AB, Velky T, Hoyt DB. Head-injured patients who "talk and die": the San Diego perspective. J Trauma. 2007 Feb;62(2):277-81. doi: 10.1097/TA.0b013e31802ef4a3.

  PMID: 17297312 BACKGROUND

• Livingston DH, Lavery RF, Passannante MR, Skurnick JH, Baker S, Fabian TC, Fry DE, Malangoni MA. Emergency department discharge of patients with a negative cranial computed tomography scan after minimal head injury. Ann Surg. 2000 Jul;232(1):126-32. doi: 10.1097/00000658-200007000-00018.

  PMID: 10862205 BACKGROUND

• Marshall LF, Marshall SB, Klauber MR, van Berkum Clark M, Eisenberg HM, Jane JA, et al. A new classification of head injury based on computerized tomography. J Neurosurg 1991; 75: S14-S20.

  BACKGROUND

• Wardlaw JM, Easton VJ, Statham P. Which CT features help predict outcome after head injury? J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):188-92; discussion 151. doi: 10.1136/jnnp.72.2.188.

  PMID: 11796768 BACKGROUND

• Sifri ZC, Homnick AT, Vaynman A, Lavery R, Liao W, Mohr A, Hauser CJ, Manniker A, Livingston D. A prospective evaluation of the value of repeat cranial computed tomography in patients with minimal head injury and an intracranial bleed. J Trauma. 2006 Oct;61(4):862-7. doi: 10.1097/01.ta.0000224225.54982.90.

  PMID: 17033552 BACKGROUND

• af Geijerstam JL, Oredsson S, Britton M; OCTOPUS Study Investigators. Medical outcome after immediate computed tomography or admission for observation in patients with mild head injury: randomised controlled trial. BMJ. 2006 Sep 2;333(7566):465. doi: 10.1136/bmj.38918.669317.4F. Epub 2006 Aug 8.

  PMID: 16895944 BACKGROUND

• Stein SC, Burnett MG, Glick HA. Indications for CT scanning in mild traumatic brain injury: A cost-effectiveness study. J Trauma. 2006 Sep;61(3):558-66. doi: 10.1097/01.ta.0000233766.60315.5e.

  PMID: 16966987 BACKGROUND

• White H, Venkatesh B. Applications of transcranial Doppler in the ICU: a review. Intensive Care Med. 2006 Jul;32(7):981-94. doi: 10.1007/s00134-006-0173-y. Epub 2006 May 10.

  PMID: 16791661 BACKGROUND

• McQuire JC, Sutcliffe JC, Coats TJ. Early changes in middle cerebral artery blood flow velocity after head injury. J Neurosurg. 1998 Oct;89(4):526-32. doi: 10.3171/jns.1998.89.4.0526.

  PMID: 9761044 BACKGROUND

• Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. doi: 10.1007/s00134-005-2630-4. Epub 2005 Apr 16.

  PMID: 15834704 BACKGROUND

Related Links

• Username : DTC99 Password : DTCTST

MeSH Terms

Conditions

Brain Injuries, Traumatic; Lymphoma, Follicular

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Jean Francois Payen, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 8, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

FR (21)