A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty

NCT06642532 | Recruiting

• 1 other identifier: LY2024-093-B
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cranial Defect; TCD

Outcome Measures

Primary Outcomes (1)

• transcranial doppler ultrasonography parameters before and after cranioplasty

  transcranial doppler ultrasonography's hemodynamic parameters: Pulse Index（PI） of middle cerebral artery(MCA), terminal internal carotid artery(TICA), anterior communicating artery(ACA), and posterior cerebral artery(PCA) from bilateral temporal window before and after polyetheretherketone cranioplasty. PI=（Vs - Vd ）/ Vm。

  6 months

Interventions

TCD group DEVICE

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

Eligibility Criteria

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

Study Population

1. Age of 18 years or older; 2. Proposed polyetheretherketone cranioplasty; 3. Incomplete cranial bone in the lateral temporal window.

You may qualify if:

• 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.

You may not qualify if:

• )Although cranioplasty is proposed, the cranial bone in the temporal region is intact.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Junfeng Feng

CONTACT

13611860825; fengjfmail@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Director of Brain Injury Center

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)