Clinical trial · Observational
Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
Prospective, Multicentre, Observational Study
NCT01291706CI-TRIAL-00014353TCDcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Traumatic Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transcranial Doppler | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Mild TBI with mild lesions on CT scan
- description
- 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)
- interventionNames
- Device: Transcranial Doppler
Primary outcomes (1)
- measure
- Negative predictive value of transcranial doppler
- timeFrame
- within the first week after the injury
- description
- 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 outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDThornhill 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
- BACKGROUNDDavis 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
- BACKGROUNDLivingston 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
- BACKGROUNDMarshall 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.
- BACKGROUNDWardlaw 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
- BACKGROUNDSifri 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
- BACKGROUNDaf 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.