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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06189911
Other study ID # ANE-2564-08020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006
Est. completion date January 1, 2023

Study information

Verified date February 2024
Source Chiang Mai University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. What are the risk factors of peri-operative blood transfusion in open liver resection procedures 2. What are the difference outcomes between patients who receive blood transfusion and the other group. Researcher will compare perioperative factor and post operative outcomes between transfused and non-transfused group


Description:

After approval of the study protocol from the institutional review board of Chiangmai University (Approval number: ANE-2564-08020), we performed a retrospective review of all patients who underwent an elective open liver resection in our specialized hepato-biliary center from January 2006 through December 2017. This retrospective inquiry comprised 808 patients. The data was systematically retrieved from electronic medical records. Baseline characteristics including age, gender, body mass index (BMI), co-morbidity, American Society of Anesthesiologists (ASA) classification, diagnosis, hepatitis profile, Child-Pugh classification, cirrhosis, the largest tumor size, previous liver resection, and pre-operative laboratory investigations were collected. The following intra-operative data were collected: type of liver resection, hilar resection, vascular reconstruction, volume and type of fluid administration, estimated blood loss, packed red cell and blood product transfusion, and operation time. The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology


Recruitment information / eligibility

Status Completed
Enrollment 1201
Est. completion date January 1, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All genders age above 18 year old who underwent open liver resection from 2006-2017 - Elective open liver resection Exclusion Criteria: - Patients who death during the course of a surgical operation

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chiang Mai University

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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