Impact of Cranioplasty On Cerebral Perfusion

Infarction, Middle Cerebral Artery Clinical Trial

— CCP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113645
• Other study ID #: UC0901
• Secondary ID: 00006477
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: April 30, 2013
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients over 18 years of age up to 65 years

• Patients receiving a decompressive craniectomy for : severe head injuries, Subarachnoid hemorrhage, intra-cerebral hemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke and undergoing to reconstructive cranioplasty

• Patients informed about the study and giving consent

Exclusion Criteria:

• Patients being not assisted by the French NHS

• Patients allergic to CT contrast products

• Pregnant and nursing women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Thrombosis
• Craniocerebral Trauma
• Head Injuries
• Hemorrhage
• Infarction, Middle Cerebral Artery
• Intra-cerebral Haemorrhage
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
France	Service de Neurochirurgie - LARIBOISIERE	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Chibbaro S, Di Rocco F, Mirone G, Fricia M, Makiese O, Di Emidio P, Romano A, Vicaut E, Menichelli A, Reiss A, Mateo J, Payen D, Guichard JP, George B, Bresson D. Decompressive craniectomy and early cranioplasty for the management of severe head injury: a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of local and global cerebral hemodynamic and blood flow	1 week prior and 6 weeks post cranioplasty by CT perfusion scan and trans-cranial doppler.	at 6 weeks	No
Secondary	Outcome evaluation by Glasgow Outcome Score (GOS), frontal assessment battery (FAB), and mini mental state examination (MMSE) scores	at 1 week prior and 6 and 24 weeks post cranioplasty.	at 6 and 24 weeks	No
Secondary	Evaluation of local and global cerebral hemodynamic and blood flow	24 weeks post cranioplasty by trans-cranial Doppler	at 24 weeks	No