Post-craniotomySCORESNCT06762184
Scores in Critically Ill Patients After Craniotomy
An observational study of Post-craniotomy and Critical Illness, run by Beijing Tiantan Hospital at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-craniotomy, Critical Illness, Mortality
- How many people
- 1,600 participants
- Where
- 1 siteChile
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Patients admitted to the ICU wards between 2017 and 2020
- Patients underwent craniotomy
- Patientshad an ICU stay of more than 24 hours
Who cannot join
- Pregnant or lactating women
- Patients enrolled in other clinical studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, 100070
Jianfang Zhou Zhou, MD, 8610-59978451, zjfyanger@sina.com
About this study
Official title: 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.
Read the 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.
- Keywords
- critical ill, post-craniotomy, APACHE II, SOFA, SAPS II, GCS, GCS-P, mortality
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-craniotomyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762184
- Sponsor's protocol ID
- JZhou-2
- Acronym
- SCORES
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification
Publications
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.
PubMed 41638721
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06762184
- Acronym / sponsor ID
- SCORES / JZhou-2
- Keywords
- critical ill, post-craniotomy, APACHE II, SOFA, SAPS II, GCS, GCS-P, mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Patients admitted to the ICU wards between 2017 and 2020
- Patients underwent craniotomy
- Patientshad an ICU stay of more than 24 hours
Key exclusion criteria (2 listed)
- Pregnant or lactating women
- Patients enrolled in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 41638721Zhou 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-craniotomy and Critical Illness, run by Beijing Tiantan Hospital at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianfang Zhou Zhou, MD (8610-59978451, zjfyanger@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive value of different scoring systems (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.