Liver InjuryNCT06080308
Liver Ischemia-reperfusion Injury and Clinical Data Analysis
An observational study of Liver Injury, run by Qin Zhang at 1 site in China.
Trial summary
Searching for new targets for the diagnosis and treatment of liver ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Injury
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Adult, Older adult
Study population: Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.
Who may be able to join
- Willingness to participate in the study and has signed an informed consent form. 2) Age ≥ 18 years and ≤ 70 years. 3) ASA classification ≤ III. 4) Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.
Who cannot join
- 1) Patients with adverse events during surgery. 2) Patients in the end stage of disease with liver failure. 3) Liver tumor metastasis with concomitant severe heart failure or chronic renal insufficiency, etc. 4) Deemed unsuitable for participation in the study based on the judgment of the researchers.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Qin Zhang, phd, 15717154768, qzhang8@tjh.tjmu.edu.cn
Xiao Ran, phd, 15926207366, ranxiao1001@tjh.tjmu.edu.cn
About this study
Official title: Research on the Molecular Mechanisms of Liver Ischemia-reperfusion Injury and Clinical Data Analysis: an Observational Study
Searching for new targets for the diagnosis and treatment of liver ischemia-reperfusion injury.
Read the detailed description
Through the analysis of serological data during liver resection elective surgery with hepatic pedicle occlusion and reperfusion, as well as the analysis of patient-related data, we aim to identify key target points that affect reperfusion injury and explore their underlying mechanisms.
- Conditions
- Liver Injury
- Being tested
- No intervention
- Keywords
- Hepatic ischemia; Reperfusion injury
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Oct 2023
- Primary completion20 Dec 2023
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080308
- Sponsor's protocol ID
- TJ-IRB20230940
- Status last verified
- Apr 2024
- First submitted
- 6 Oct 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Molecular Mechanisms of Liver Ischemia-reperfusion Injury and Clinical Data Analysis: an Observational Study
- ClinicalTrials.gov ID
- NCT06080308
- Acronym / sponsor ID
- TJ-IRB20230940
- Conditions
- Liver Injury
- Keywords
- Hepatic ischemia; Reperfusion injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Oct 2023 (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.
Searching for new targets for the diagnosis and treatment of liver ischemia-reperfusion injury.
Detailed description
Through the analysis of serological data during liver resection elective surgery with hepatic pedicle occlusion and reperfusion, as well as the analysis of patient-related data, we aim to identify key target points that affect reperfusion injury and explore their underlying mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.
Key inclusion criteria (1 listed)
- Willingness to participate in the study and has signed an informed consent form. 2) Age ≥ 18 years and ≤ 70 years. 3) ASA classification ≤ III. 4) Criteria for liver ischemia-reperfusion injury patients: patients undergoing elective liver resection surgery with hepatic pedicle occlusion and reperfusion during the procedure.
Key exclusion criteria (2 listed)
- 1) Patients with adverse events during surgery. 2) Patients in the end stage of disease with liver failure. 3) Liver tumor metastasis with concomitant severe heart failure or chronic renal insufficiency, etc. 4) Deemed unsuitable for participation in the study based on the judgment of the researchers.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Length of hospital stay
Time frame: 7days
Length of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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. This study is not recruiting at the moment.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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 Liver Injury, run by Qin Zhang at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.