- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06762184
Scores in Critically Ill Patients After Craniotomy (SCORES)
February 8, 2025 updated by: Beijing Tiantan Hospital
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
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Estimated)
1600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianfang Zhou Zhou, MD
- Phone Number: 8610-59978451
- Email: zjfyanger@sina.com
Study Locations
-
-
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Beijing, Chile, 100070
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Jianfang Zhou Zhou, MD
- Phone Number: 8610-59978451
- Email: zjfyanger@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
predictive value of different scoring systems
Time Frame: 3 months
|
We would evaluate the predictive value of different scoring systems for in-hospital mortality in critically ill patients following craniotomy.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
January 1, 2025
First Submitted That Met QC Criteria
January 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 8, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JZhou-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.