Impact of Cranioplasty On Cerebral Perfusion

NCT01113645 | Completed

• 2 other identifiers: UC090100006477
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Injuries; Subarachnoid Haemorrhage; Intra-cerebral Haemorrhage; Cerebral Thrombosis; Infarction, Middle Cerebral Artery

Keywords

Decompressive craniectomy; Cranioplasty; Cerebral blood flow; Cerebral hemodynamic; Neurological-cognitive test GOS, FAB, MMSE,; Transcranial Doppler

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Outcome evaluation by Glasgow Outcome Score (GOS), frontal assessment battery (FAB), and mini mental state examination (MMSE) scores

  at 6 and 24 weeks

• Evaluation of local and global cerebral hemodynamic and blood flow

  at 24 weeks

Study Arms (1)

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

Interventions

Cerebral perfusion evaluation PROCEDURE

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.

Cerebral perfusion evaluation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients being not assisted by the French NHS
• Patients allergic to CT contrast products
• Pregnant and nursing women

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Neurochirurgie - LARIBOISIERE

Paris, 75010, France

Location

Related 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 prospective multicenter study on 147 patients. World Neurosurg. 2011 Mar-Apr;75(3-4):558-62. doi: 10.1016/j.wneu.2010.10.020.

  PMID: 21600512 RESULT

MeSH Terms

Conditions

Craniocerebral Trauma; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Intracranial Thrombosis; Infarction, Middle Cerebral Artery; Fanconi Anemia, Complementation Group B

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Infarction; Ischemia; Necrosis

Study Officials

• Salvatore CHIBBARO, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 1, 2013

Record last verified: 2012-12

Locations

FR (1)