NCT06762184

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 1, 2025

Last Update Submit

February 8, 2025

Conditions

Keywords

critical illpost-craniotomyAPACHE IISOFASAPS IIGCSGCS-Pmortality

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Pregnant or lactating women
  • Patients enrolled in other clinical studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing, 100070, Chile

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jianfang Zhou Zhou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

November 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

February 11, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification

Locations