NCT06189911

Brief Summary

This observational study is specifically designed to identify the pre-operative risk factors that significantly contribute to perioperative packed red cell transfusions in open liver resection procedures. The main question it aims to answer are:

  1. 1.What are the risk factors of peri-operative blood transfusion in open liver resection procedures
  2. 2.What are the difference outcomes between patients who receive blood transfusion and the other group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

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

January 1, 2006

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

16 years

First QC Date

December 19, 2023

Last Update Submit

February 29, 2024

Conditions

Keywords

liver resectionrisk factorsblood transfusionscoring system

Outcome Measures

Primary Outcomes (1)

  • the pre-operative risk factors of perioperative packed red cell transfusions in open liver resection procedures.

    Significant risk factors for perioperative blood transfusion were determined by factors with a p-value \< 0.05 derived from the multivariable logistic regression analysis. This analysis facilitated adjustments for potential confounders to identify the independent risk factors associated with perioperative blood transfusion

    the transfusion of packed red cells during the operation and 48 hours after surgery

Study Arms (2)

transfused

Group of patients who received perioperative blood transfusions which was defined as the transfusion of packed red cells during the operation and 48 hours after surgery.

Procedure: Open liver resection

non-transfused

Group of patients who did not received perioperative blood transfusions

Procedure: Open liver resection

Interventions

The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology

non-transfusedtransfused

Eligibility Criteria

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

All adult patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017

You may qualify if:

  • All genders age above 18 year old who underwent open liver resection from 2006-2017
  • Elective open liver resection

You may not qualify if:

  • Patients who death during the course of a surgical operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Warangkana Lapisatepun, M.D.

    Chiang Mai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

January 1, 2006

Primary Completion

December 31, 2021

Study Completion

January 1, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Did not state about IPD sharing in the proposal which proposed to institutional review board.