- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952361
Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients
May 16, 2025 updated by: Ardak Arynov
Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients: A Prospective Observational Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
107
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Almaty, Kazakhstan, 050000
- Kazakh Institute of Oncology and Radiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Oxygen Extraction Ratio (O₂ER)
Time Frame: Baseline and 1 hour post-transfusion
|
Difference in oxygen extraction ratio measured before and one hour after red blood cell transfusion
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Baseline and 1 hour post-transfusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)
Time Frame: Baseline and 1 hour post-transfusion
|
Difference in PvO₂ measured before and one hour after transfusion
|
Baseline and 1 hour post-transfusion
|
|
Change in Central Venous Oxygen Saturation (ScvO₂)
Time Frame: Baseline and 1 hour post-transfusion
|
Difference in ScvO₂ measured before and one hour after transfusion
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Baseline and 1 hour post-transfusion
|
|
Change in Lactate Concentration
Time Frame: Baseline and 1 hour post-transfusion
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Difference in serum lactate measured before and one hour after transfusion
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Baseline and 1 hour post-transfusion
|
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Change in Arterio-Venous Oxygen Difference (A-VO₂diff)
Time Frame: Baseline and 1 hour post-transfusion
|
Difference in arteriovenous oxygen difference measured before and one hour after transfusion
|
Baseline and 1 hour post-transfusion
|
|
Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)
Time Frame: Baseline and 1 hour post-transfusion
|
Difference in ΔCO₂ measured before and one hour after transfusion
|
Baseline and 1 hour post-transfusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ARDAK A ARYNOV, M.D., Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, Kazakhstan
- Study Chair: 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Actual)
November 24, 2021
Study Completion (Actual)
November 24, 2021
Study Registration Dates
First Submitted
April 23, 2025
First Submitted That Met QC Criteria
April 23, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Actual)
May 21, 2025
Last Update Submitted That Met QC Criteria
May 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KazIOR-ALTTRANS-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The study results will be published in aggregated form only.
No individual participant data (IPD) will be shared.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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