AnemiaNCT06952361
Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients
An observational study of Anemia and Blood Transfusion, run by Ardak Arynov at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Blood Transfusion, Cancer
- What is being tested?
- Red blood cell transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 107 participants
- Where
- 1 siteKazakhstan
- Study dates
- 8 Mar 2019to 24 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anemia, Blood Transfusion, Cancer, Hemoglobin, Alternative Physiological Transfusion Triggers
- Being tested
- Red blood cell transfusion
- Keywords
- anemia, red blood cell transfusion, physiologic transfusion trigger, alternative transfusion trigger, oxygen extraction ratio, central venous oxygen saturation
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Extraction Ratio (O₂ER)
Difference in oxygen extraction ratio measured before and one hour after red blood cell transfusion
Measured: Baseline and 1 hour post-transfusion
Secondary outcomes (5)
Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)
Difference in PvO₂ measured before and one hour after transfusion
Measured: Baseline and 1 hour post-transfusion
Change in Central Venous Oxygen Saturation (ScvO₂)
Difference in ScvO₂ measured before and one hour after transfusion
Measured: Baseline and 1 hour post-transfusion
Change in Lactate Concentration
Difference in serum lactate measured before and one hour after transfusion
Measured: Baseline and 1 hour post-transfusion
Change in Arterio-Venous Oxygen Difference (A-VO₂diff)
Difference in arteriovenous oxygen difference measured before and one hour after transfusion
Measured: Baseline and 1 hour post-transfusion
Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)
Difference in ΔCO₂ measured before and one hour after transfusion
Measured: Baseline and 1 hour post-transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start8 Mar 2019
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardak Arynov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ardak Arynov, Kazakh Institute of Oncology and Radiology
- Investigators
- ARDAK A ARYNOV, M.D., Principal investigator, Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, KazakhstanEvgeni Brotfain, M.D., Professor, Study chair, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952361
- Sponsor's protocol ID
- KazIOR-ALTTRANS-2019
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study results will be published in aggregated form only. No individual participant data (IPD) will be shared.
Publications
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;16(1):2831. doi: 10.1038/s41598-025-32630-6.
PubMed 41419638
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06952361
- Acronym / sponsor ID
- KazIOR-ALTTRANS-2019
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ardak ArynovUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients with Anemia Receiving RBC Transfusion | – | Procedure: Red blood cell transfusionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Hemodynamic instability requiring inotropic or vasopressor support
- Active bleeding
- Shock of any etiology
- Patient refusal to participate in the study
- Hematological malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionStandard 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. | Procedure or surgery | Cancer Patients with Anemia Receiving RBC Transfusion |
Primary outcome
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
5 secondary outcomes
Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)
Time frame: Baseline and 1 hour post-transfusion
Change in Central Venous Oxygen Saturation (ScvO₂)
Time frame: Baseline and 1 hour post-transfusion
Change in Lactate Concentration
Time frame: Baseline and 1 hour post-transfusion
Change in Arterio-Venous Oxygen Difference (A-VO₂diff)
Time frame: Baseline and 1 hour post-transfusion
Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)
Time frame: Baseline and 1 hour post-transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41419638Arynov 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;16(1):2831. doi: 10.1038/s41598-025-32630-6.
- Individual participant dataSharing planned: No. The study results will be published in aggregated form only. No individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ARDAK A ARYNOV, M.D. principal investigator
Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, Kazakhstan
Evgeni Brotfain, M.D., Professor study chair
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Blood Transfusion, run by Ardak Arynov at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen Extraction Ratio (O₂ER) (time frame: Baseline and 1 hour post-transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.