Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients

NCT06952361 | Completed

• 1 other identifier: KazIOR-ALTTRANS-2019
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center observational study conducted at the Kazakh Institute of Oncology and Radiology. The study included 107 clinically stable adult patients with cancer who required red blood cell transfusion based on a restrictive hemoglobin threshold. The aim of the study was to evaluate alternative physiological indicators of transfusion need and effectiveness. Measurements included oxygen extraction ratio (O₂ER), central venous oxygen saturation (ScvO₂), partial pressure of oxygen in central venous blood (PvO₂), arterio-venous oxygen difference (A-VO₂diff), lactate, and veno-arterial carbon dioxide difference (ΔCO₂). These parameters were assessed before and one hour after transfusion. For data analysis, patients were stratified into two groups based on their baseline O₂ER (≤35.4% and \>35.4%) to evaluate whether higher O₂ER is associated with more pronounced physiological response to transfusion.

Conditions

Anemia; Blood Transfusion; Cancer; Hemoglobin; Alternative Physiological Transfusion Triggers

Keywords

anemia; red blood cell transfusion; physiologic transfusion trigger; alternative transfusion trigger; oxygen extraction ratio; central venous oxygen saturation

Outcome Measures

Primary Outcomes (1)

• Change in Oxygen Extraction Ratio (O₂ER)

  Difference in oxygen extraction ratio measured before and one hour after red blood cell transfusion

  Baseline and 1 hour post-transfusion

Secondary Outcomes (5)

• Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)

  Baseline and 1 hour post-transfusion

• Change in Central Venous Oxygen Saturation (ScvO₂)

  Baseline and 1 hour post-transfusion

• Change in Lactate Concentration

  Baseline and 1 hour post-transfusion

• Change in Arterio-Venous Oxygen Difference (A-VO₂diff)

  Baseline and 1 hour post-transfusion

• Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)

  Baseline and 1 hour post-transfusion

Study Arms (1)

Cancer Patients with Anemia Receiving RBC Transfusion

This group includes clinically stable, non-ventilated adult oncology patients with anemia who received red blood cell transfusion at the Kazakh Institute of Oncology and Radiology. All participants were monitored for physiological parameters-including O₂ER, ScvO₂, PvO₂, A-VO₂diff, lactate, and ΔCO₂-before and one hour after transfusion.

Procedure: Red blood cell transfusion

Interventions

Red blood cell transfusion PROCEDURE

Standard red blood cell transfusion performed as part of routine clinical care. All participants received one or more units of RBCs based on a restrictive hemoglobin threshold. The transfusion protocol was not altered for the purpose of the study.

Cancer Patients with Anemia Receiving RBC Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically stable, non-ventilated adult oncology patients with anemia who required red blood cell transfusion as part of routine clinical care at the Kazakh Institute of Oncology and Radiology.

You may qualify if:

• Adult cancer patients (age 18 years or older)
• Hemodynamically stable
• Not requiring any form of respiratory support
• Presence of a central venous catheter inserted into the superior vena cava

You may not qualify if:

• Hemodynamic instability requiring inotropic or vasopressor support
• Active bleeding
• Shock of any etiology
• Patient refusal to participate in the study
• Hematological malignancies
• Age under 18 years
• Pregnancy

Sponsors & Collaborators

• Ardak Arynov: lead

Study Sites (1)

Kazakh Institute of Oncology and Radiology

Almaty, 050000, Kazakhstan

Location

Related Publications (1)

• Arynov A, Gratz J, Kabon B, Kaidarova D, Satanova A, Brotfain E. Evaluation of alternative transfusion triggers in hemodynamically stable, non-ventilated cancer patients: a prospective observational study. Sci Rep. 2025 Dec 19. doi: 10.1038/s41598-025-32630-6. Online ahead of print.

  PMID: 41419638 DERIVED

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• ARDAK A ARYNOV, M.D.

  Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, Kazakhstan

  PRINCIPAL INVESTIGATOR

• Evgeni Brotfain, M.D., Professor

  Division of Anesthesia and Critical Care, Director of Post Anesthesia Care Unit, Soroka University Medical Center, Ben Gurion University of the Negev, Be'er Sheva, Israel

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: March 8, 2019
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: May 21, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)