A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TCD group.
- Who it may be relevant to
- Registry conditions: Cranial Defect, TCD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Polyetheretherketone has become one of the most important material choices for cranioplasty surgery. It has been shown that conventional ultrasound can be performed through the polyetheretherketone material for the examination of brain tissue and ventricular morphology. Transcranial doppler ultrasound can obtain good images of cerebral hemodynamic parameters in patients through polyetheretherketone-covered temporal window. This trial is a clinical prospective observational study in which cases treated with polyetheretherketone cranioplasty, and transcranial doppler ultrasonography is performed preoperatively and 10 days postoperatively, and data were collected mainly including bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window.
Interventions
- Device TCD group
Transcranial Doppler ultrasound to examine bilateral hemodynamic parameters of middle cerebral artery(MCA), terminal internal carotid artery(TICA), (anterior communicating artery)ACA, and posterior cerebral artery(PCA) (Vs, Vd, Vm, PI index, RI index) from temporal window
Primary outcome measures
- transcranial doppler ultrasonography parameters before and after cranioplasty [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age of 18 years or older;
- Proposed polyetheretherketone cranioplasty;
- Incomplete cranial bone in the lateral temporal window;
- Signed informed consent for surgery and informed consent for research.
Exclusion criteria
1)Although cranioplasty is proposed, the cranial bone in the temporal region is intact.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 2 centers
- Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong Univer — Shanghai
- Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong Univers — Shanghai
Identifiers
NCT: NCT06642532 · LY2024-093-B