Clinical Trial: Impact of Cranioplasty On Cerebral Perfusion

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.

Brief Summary: The purpose of this study is to examine the impact of cranioplasty on cerebral hemodynamic and blood flow as prognostic factor in patients receiving decompressive craniectomy for Head injuries, Subarachnoid haemorrhage, intra-cerebral haemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke.

Detailed Summary: Background: The decompressive craniectomy has recently experienced a renewed interest in the international neurosurgical community: the number of patients receiving decompressive craniectomy has remarkably increased over last decades. Nowadays the most widely recognized indications for cranioplasty is aesthetic reconstruction and protection of brain against external injuries; it is usually performed several months after the craniectomy. Unexpected improvements of patients neurological status were noted but this phenomenon remains unexplained. This could be due to the reduction of local cerebral compression caused by atmospheric pressure, to improved cerebrospinal fluid hydrodynamics and possibly to the improvement of local and global cerebral hemodynamics, blood flow and metabolism. Main objective: To evaluate changes in local and global cerebral hemodynamics and blood flow before and after skull bone reconstruction. Patients and Methods: Pilot observational study on 20 patients. Inclusion criteria: Patient over 18 and up to 65 years who underwent decompressive craniectomy after severe head injury, subarachnoid hemorrhage, intracerebral hemorrhage, venous sinus thrombosis with hemorrhage / malignant edema and malignant middle cerebral artery stroke requiring of course reconstructive cranioplasty. Exclusion criteria: Patient not affiliated to the French NHS, pregnant and/or nursing women, patients being allergic to CT scan contrast products. Study Protocol: 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 tran
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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.


Original Primary Outcome: 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 doopler


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Outcome evaluation by GOS, FAB and 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


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 28, 2010
Date Started: July 2010
Date Completion:
Last Updated: April 30, 2013
Last Verified: December 2012