A Nomogram Predicting the Risk of High-dose Transfusion in Non-cardiac Surgery

Development and Validation of a Nomogram Predicting the Risk of Perioperative High-dose Transfusion in Non-cardiac Surgery

This retrospective study was designed to develop a preoperative nomogram, validated both internally and externally, to supply an individual and precise tool for predicting the probability that patients will require perioperative transfusion therapy.

Study Overview

• Status: Completed
• Conditions: Massive Transfusion; Nomogram Model

Detailed Description

Perioperative red blood cells (RBCs) transfusion is a necessary guarantee for surgical surgery and one of the indispensable means in modern medical treatment. In recent years, with the continuous improvement of medical standards, various major and complex surgeries have been carried out. The total number of patients receiving surgical treatment increased year by year, and the demand for surgical blood has also increased rapidly. Although unpaid blood donation has been vigorously advocated in recent years, the supply of blood products are still difficult to meet the growing demand for clinical blood. RBCs transfusion is often associated with unavoidable complications such as anaphylaxis and transfusion-related acute lung injury, which may lead to delayed recovery, increased hospital stay and medical costs, and result in serious adverse effects and even death.

Hemorrhage is a common complication of surgery. The effect of blood transfusion treatment and the patient's recovery process will be affected by the amount of blood transfused during the perioperative period. Similarly, blood products that are prepared in advance for surgery often remains unused perioperatively, leading to the waste of valuable blood resources and an increase in hospital expenses. Hemorrhage is one of the leading causes of death in various clinical situations, such as severe trauma, heart surgery, and traffic accidents.Timely and effective high-dose transfusion is directly related to life and death. However, high-dose transfusion may also lead to dilution coagulopathy, increased risk of bleeding, and imbalance in the internal environment.

In brief, there is an urgent requirement for a systematic, evidence-driven tool to comprehensively weigh the risks and benefits of high-dose RBCs transfusion in clinical practice.

• Study Type: Observational
• Enrollment (Actual): 11197

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This retrospective study included 【】patients who received RBCs transfusion during non-cardiac surgery at West China Hospital between January 2018 and June 2024.

Description

Inclusion Criteria:

• Patients undergoing non-cardiac surgery during hospitalization.
• Patients receiving allogeneic RBCs transfusion within 24 hours during and after surgery.

Exclusion Criteria:

• Age under 15 years.
• Patients with incomplete clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
High-dose group; Receive RBCs transfusion over 1600mL
No-high-dose group; Receive RBCs transfusion under 1600mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBCs transfusion volume	The total volume of RBCs transfused within 24 from the start of transfusion.	Up to 24 hours after transfusion

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Ren Liao, M.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Massive transfusion; Non-cardiac surgery; Patient blood management; Red blood cells; Nomogram
• Other Study ID Numbers: WCH20231634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No