Liver Ischemia-reperfusion Injury and Clinical Data Analysis | NCT06080308

Studies
Liver Ischemia-reperfusion Injury and Clinical Data Analysis

NCT06080308

Sponsor

Qin Zhang

Status

Unknown status

Last Update Posted

Apr 10, 2024Actual

Enrollment

270Estimated

Phase

Not provided

Conditions

Liver Injury

Interventions

No intervention

Countries

China

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2023Actual

Primary Completion Date

Dec 20, 2023Actual

Completion Date

Sep 30, 2024Estimated

First Submitted Date

Oct 6, 2023

First Submission Date that Met QC Criteria

Oct 6, 2023

First Posted Date

Oct 12, 2023Actual

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

Apr 8, 2024

Last Update Posted Date

Apr 10, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

Retention

Enrollment

270Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay	Length of hospital stay	7days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430030	China

Condition Browse Module

MeSH Terms

ID	Term
D015427	Reperfusion Injury

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided