Impact of Cranioplasty On Cerebral Perfusion
Condition: Head Injuries; Subarachnoid Haemorrhage; Intra-cerebral Haemorrhage; Cerebral Thrombosis; Infarction, Middle Cerebral Artery
MeSH terms: Subarachnoid Hemorrhage; Craniocerebral Trauma; Cerebral Hemorrhage; Infarction, Middle Cerebral Artery; Intracranial Thrombosis; Thrombosis; Infarction; Hemorrhage
Study type: Observational

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 description: 
      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 trans-cranial Doppler 1 week prior and 6 and 24 weeks post
      cranioplasty. Expected Benefits: Better knowledge of local and global hemodynamic changes in
      patients after cranioplasty, its possible impact on neurological outcome and as a prognostic
      factor. Duration of the inclusion period: 1 year Duration of patient participation: 25 weeks
      (approximately 6 months) Total duration of the study: 1 year and 25 weeks (about 1 and ½
      year) Number of patients: 20 Main endpoints: Evaluation of local and global cerebral
      hemodynamics and blood flow 6 weeks post cranioplasty by CT perfusion scan and trans-cranial
      Doppler. Secondary endpoints: - Evaluation of neurological and cognitive performances by GOS,
      FAB and MMSE scores 1 week prior and 6 and 24 weeks post cranioplasty. - Evaluation of local
      and global cerebral hemodynamics and blood flow by transcranial Doppler 24 weeks post
      cranioplasty. Statistical analysis: This is a pilot study whose size was determined on the
      basis of its feasibility (one year). Besides its own interest, this study will clarify the
      conditions for a future comparative study comparing different strategies of cranioplasty.
    

Intervention name(s): Cerebral perfusion evaluation
Intervention type(s): Procedure
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: Decompressive craniectomy; Cranioplasty; Cerebral blood flow; Cerebral hemodynamic; Neurological-cognitive test GOS, FAB, MMSE,; Transcranial Doppler