Impact of Cranioplasty On Cerebral Perfusion (CCP)
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|ClinicalTrials.gov Identifier: NCT01113645|
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : May 1, 2013
|Condition or disease||Intervention/treatment|
|Head Injuries Subarachnoid Haemorrhage Intra-cerebral Haemorrhage Cerebral Thrombosis Infarction, Middle Cerebral Artery||Procedure: Cerebral perfusion evaluation|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||The Impact of Cranioplasty on Local and Global Cerebral Blood Flow as Clinical Outcome Prognostic Factor in Patients Undergoing Decompressive Craniectomy for Severe Head Injury.|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||April 2012|
Cerebral perfusion evaluation
All patients are evaluated by GOS (Glasgow Outcome Score) and neurocognitive tests by FAB (frontal assessment battery) and MMSE (mini mental state examination) scores. Hemodynamic monitoring by CT perfusion scan, as well as by trans-cranial Doppler.
Procedure: Cerebral perfusion evaluation
The patient who received a craniectomy is included in the study and an information notice given to him. All patients are evaluated by GOS (Glasgow Outcome Score) and neurocognitive tests by FAB (frontal assessment battery) and MMSE (mini mental state examination) scores 1 week prior and 6 and 24 weeks post cranioplasty. Furthermore, hemodynamic monitoring is performed by CT perfusion scan (with quantitative assessment of global and local cerebral flow) 1 week prior and 6 weeks post cranioplasty, as well as by trans-cranial Doppler 1 week prior and 6 and 24 weeks post cranioplasty.
- Evaluation of local and global cerebral hemodynamic and blood flow [ Time Frame: at 6 weeks ]1 week prior and 6 weeks post cranioplasty by CT perfusion scan and trans-cranial doppler.
- Outcome evaluation by Glasgow Outcome Score (GOS), frontal assessment battery (FAB), and mini mental state examination (MMSE) scores [ Time Frame: at 6 and 24 weeks ]at 1 week prior and 6 and 24 weeks post cranioplasty.
- Evaluation of local and global cerebral hemodynamic and blood flow [ Time Frame: at 24 weeks ]24 weeks post cranioplasty by trans-cranial Doppler
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113645
|Service de Neurochirurgie - LARIBOISIERE|
|Paris, France, 75010|
|Principal Investigator:||Salvatore CHIBBARO, MD||Assistance Publique - Hôpitaux de Paris|