Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury (TCD)
This study has been completed.
Sponsor:
University Hospital, Grenoble
Collaborator:
CIC Clinical Investigation Centre Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01291706
First received: February 7, 2011
Last updated: April 25, 2014
Last verified: April 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Device: Transcranial Doppler |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective, Multicentre, Observational Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Grenoble:
Primary Outcome Measures:
- Negative predictive value of transcranial doppler [ Time Frame: within the first week after the injury ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- the impact of transcranial doppler for initial patient management [ Time Frame: within the first week after trauma ] [ Designated as safety issue: No ]
Number of brain CTscan performed within 7 days after the trauma.
Number of devices inserted to monitor intracranial pressure.
Secondary admissions to intensive care unit.
Length of hospital stay.
- Secondary neurological aggravation: risk factors and consequences. [ Time Frame: neurological outcome on D7 and D28 ] [ Designated as safety issue: No ]
Neurological outcome on day 7 and day 28 after trauma, as measured with disability rating scale.
Number and type of interventions for neurological deterioration
| Enrollment: | 369 |
| Study Start Date: | February 2011 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
|
Eligibility| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Criteria for inclusion:
- 15 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
Criteria for exclusion:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01291706
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291706
Locations
| France | |
| CHU Grenoble | |
| Grenoble, Isere, France, 38043 | |
| CHRA Annecy | |
| Annecy, Rhone Alpes, France, 74000 | |
| Ch Belley | |
| Belley, France | |
| CHU | |
| Besancon, France | |
| Ch Briancon | |
| Briancon, France | |
| Ch Cannes | |
| Cannes, France | |
| Ch Chambery | |
| Chambery, France | |
| CHU | |
| Clermont Ferrand, France | |
| CHU | |
| Dijon, France | |
| Ch Grasse | |
| Grasse, France | |
| Chu Edouard Herriot | |
| Lyon, France | |
| CHU Lyon | |
| Lyon, France | |
| CHU Pierre Benite | |
| Lyon, France | |
| CH Nantes | |
| Nantes, France | |
| Chu Nimes | |
| Nimes, France | |
| Ch Saint Jean de Maurienne | |
| Saint Jean de Maurienne, France | |
| Hopitaux Du Pays Du Mont Blanc | |
| Sallanches, France | |
| Ch Saint Julien En Genevois | |
| St Julien En Genevois, France | |
| Ch Thonon Les Bains | |
| Thonon Les Bains, France | |
| CH Valence | |
| Valence, France | |
| Ch Voiron | |
| Voiron, France | |
Sponsors and Collaborators
University Hospital, Grenoble
CIC Clinical Investigation Centre Grenoble
Investigators
| Principal Investigator: | Jean Francois Payen, MD | University Hospital, Grenoble |
More Information
Additional Information:
Publications:
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.
| Responsible Party: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT01291706 History of Changes |
| Other Study ID Numbers: | DCIC 10 17 |
| Study First Received: | February 7, 2011 |
| Last Updated: | April 25, 2014 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by University Hospital, Grenoble:
|
Transcranial Doppler Mild and moderate Traumatic Brain Injury Neurological deterioration Brain CT scan |
Additional relevant MeSH terms:
|
Wounds and Injuries Brain Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
ClinicalTrials.gov processed this record on September 27, 2016