Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

Skull Injury Trauma Clinical Trial

Official title:

Multicenter Clinical Study on Diagnosis and Treatment of Skull Base Trauma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02571023
• Other study ID #: Skull Base Trauma 2016
• Status: Not yet recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 7, 2015
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2015
• Source: Shanghai Changzheng Hospital
• Contact: Lijun Hou, MD
• Phone: 008602181885671
• Email: 15921509289[@]163.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical Trial Summary

The purposes of this study are as follows:

1. to collect the largest epidemiological data of skull base trauma and analyze the related influence factors of mortality and morbidity.

2. to establish a set of standard classification methods of skull base trauma and to establish a standard rating scale for each type of trauma.

3. to select optimized conservative and surgical treatments of skull base trauma and to compare the therapeutic effect between microscope surgery and neuroendoscopic surgery.

4. to clear the epidemiological characteristics of the skull base trauma combined with paroxysmal sympathetic hyperactivity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Skull Base Trauma

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Skull Injury Trauma
• Wounds and Injuries

Intervention

Procedure:
• microscope surgery

• neuroendoscope surgery

Locations

Country	Name	City	State
China	Department of Neurosurgery, Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hou Lijun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		1 year	No
Primary	disability rate		1 year	No