Scores in Critically Ill Patients After Craniotomy | NCT06762184

Studies
Scores in Critically Ill Patients After Craniotomy

NCT06762184

Sponsor

Beijing Tiantan Hospital

Status

Recruiting

Last Update Posted

Feb 11, 2025Actual

Enrollment

1,600Estimated

Phase

Not provided

Conditions

Post-craniotomy
Critical Illness
Mortality
Severity of Illness Scores

Interventions

Not provided

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Jan 1, 2025

First Submission Date that Met QC Criteria

Jan 1, 2025

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2025

Last Update Posted Date

Feb 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study planned to review patients admitted to three ICU wards at Beijing Tiantan Hospital between 2017 and 2020. It focused on adult patients who had undergone craniotomy and stayed in the ICU for more than 24 hours. Researchers intended to collect patient information, surgery details, complications, and outcomes from medical records. They also planned to gather routine scoring data used at the hospital and double-check its accuracy. Patients would be divided into two groups based on whether they survived or not, and the ability of different scoring systems to predict outcomes would be analyzed. Additionally, the study aimed to group patients by the type of surgery and assess how well the scoring systems predicted outcomes for each group.

Detailed Description

This study would screen patients admitted to three ICU wards at Beijing Tiantan Hospital from 2017 to 2020. Adult postoperative craniotomy patients with an ICU stay of more than 24 hours would be included. Baseline information, surgery-related data, complications, and outcomes would be retrospectively collected. Routine scoring assessments conducted at our center would be gathered, and researchers would verify the accuracy of the scoring data. Based on patient outcomes, the cohort would be divided into a mortality group and a survival group. The predictive value of different scoring systems for patient outcomes would be evaluated. Additionally, patients would be grouped according to surgical indications, and the predictive value of the scoring systems for outcomes in patients with different surgical indications would be assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
predictive value of different scoring systems	We would evaluate the predictive value of different scoring systems for in-hospital mortality in critically ill patients following craniotomy.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU wards between 2017 and 2020
Patients underwent craniotomy
Patientshad an ICU stay of more than 24 hours

Exclusion Criteria:

Pregnant or lactating women
Patients enrolled in other clinical studies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the ICU wards between 2017 and 2020 would be screened, and those who underwent craniotomy and had an ICU stay of more than 24 hours were eligible for inclusion. For patients with multiple ICU admissions during a single hospitalization, only the first admission was included. Pregnant or lactating women, as well as patients enrolled in other clinical studies, would be excluded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfang Zhou Zhou, MD	Contact	8610-59978451		zjfyanger@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital, Capital Medical University	Recruiting	Beijing	Beijing	100070	Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41638721	Derived	Zhou J, Luo XY, Li HL, Shi GZ, Chen GQ. Comparison of the predictive value of APACHE II, SOFA, SAPS II, GCS and GCS-P scores for in-hospital mortality in critically ill patients after craniotomy: a retrospective cohort study in a Chinese tertiary hospital. BMJ Open. 2026 Feb 4;16(2):e101867. doi: 10.1136/bmjopen-2025-101867.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms