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NCT Number: NCT06642532

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. transcranial doppler ultrasonography parameters before and after cranioplasty

    Time frame: 6 months

    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。

Study contacts

Contact information is provided by the study sponsor or research team.

Junfeng Feng

CONTACT

[email protected]

13611860825

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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