Clinical trial NCT06952361: Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients
Official title: Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Kazakh Institute of Oncology and Radiology
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Oxygen Extraction Ratio (O₂ER)
timeFrame: Baseline and 1 hour post-transfusion
Secondary outcomes:
measure: Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)
timeFrame: Baseline and 1 hour post-transfusion
measure: Change in Central Venous Oxygen Saturation (ScvO₂)
timeFrame: Baseline and 1 hour post-transfusion
measure: Change in Lactate Concentration
timeFrame: Baseline and 1 hour post-transfusion
measure: Change in Arterio-Venous Oxygen Difference (A-VO₂diff)
timeFrame: Baseline and 1 hour post-transfusion
measure: Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)
timeFrame: Baseline and 1 hour post-transfusion
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, Kazakhstan
name: ARDAK A ARYNOV, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Evgeni Brotfain, M.D., Professor
role: STUDY_CHAIR
References: