Perioperative Blood Transfusion in Open Liver Resection

The Risk Factors for Perioperative Blood Transfusion in Open Liver Resection, a Retrospective Cohort Study Development of a Transfusion Scoring System to Predict the Requirement for Perioperative Blood Transfusion in Open Liver Resection

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

Study Overview

• Status: Completed
• Conditions: Blood Loss, Postoperative
• Intervention / Treatment: Procedure: Open liver resection

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 1201

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The definitions of liver resection and the type of hepatectomy were aligned with the anatomic classification of the Brisbane 2000 Terminology
non-transfused; Group of patients who did not received perioperative blood transfusions	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Warangkana Lapisatepun, M.D., Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: risk factors; blood transfusion; liver resection; scoring system
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage
• Other Study ID Numbers: ANE-2564-08020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Did not state about IPD sharing in the proposal which proposed to institutional review board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No