Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-31 @ 5:36 PM
Study NCT ID:
NCT06952361
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2025-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017707', 'term': 'Erythrocyte Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oxygen Extraction Ratio (O₂ER)', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in oxygen extraction ratio measured before and one hour after red blood cell transfusion'}], 'secondaryOutcomes': [{'measure': 'Change in Partial Pressure of Oxygen in Central Venous Blood (PvO₂)', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in PvO₂ measured before and one hour after transfusion'}, {'measure': 'Change in Central Venous Oxygen Saturation (ScvO₂)', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in ScvO₂ measured before and one hour after transfusion'}, {'measure': 'Change in Lactate Concentration', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in serum lactate measured before and one hour after transfusion'}, {'measure': 'Change in Arterio-Venous Oxygen Difference (A-VO₂diff)', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in arteriovenous oxygen difference measured before and one hour after transfusion'}, {'measure': 'Change in Veno-Arterial Carbon Dioxide Difference (ΔCO₂)', 'timeFrame': 'Baseline and 1 hour post-transfusion', 'description': 'Difference in ΔCO₂ measured before and one hour after transfusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anemia', 'red blood cell transfusion', 'physiologic transfusion trigger', 'alternative transfusion trigger', 'oxygen extraction ratio', 'central venous oxygen saturation'], 'conditions': ['Anemia', 'Blood Transfusion', 'Cancer', 'Hemoglobin', 'Alternative Physiological Transfusion Triggers']}, 'referencesModule': {'references': [{'pmid': '41419638', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult cancer patients (age 18 years or older)\n* Hemodynamically stable\n* Not requiring any form of respiratory support\n* Presence of a central venous catheter inserted into the superior vena cava\n\nExclusion Criteria:\n\n* Hemodynamic instability requiring inotropic or vasopressor support\n* Active bleeding\n* Shock of any etiology\n* Patient refusal to participate in the study\n* Hematological malignancies\n* Age under 18 years\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06952361', 'briefTitle': 'Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kazakh Institute of Oncology and Radiology'}, 'officialTitle': 'Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'KazIOR-ALTTRANS-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer Patients with Anemia Receiving RBC Transfusion', 'description': '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.', 'interventionNames': ['Procedure: Red blood cell transfusion']}], 'interventions': [{'name': 'Red blood cell transfusion', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Cancer Patients with Anemia Receiving RBC Transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh Institute of Oncology and Radiology', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}], 'overallOfficials': [{'name': 'ARDAK A ARYNOV, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology, Almaty city, Kazakhstan'}, {'name': 'Evgeni Brotfain, M.D., Professor', 'role': 'STUDY_CHAIR', '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"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study results will be published in aggregated form only. No individual participant data (IPD) will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardak Arynov', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Intensive Care, Kazakh Institute of Oncology and Radiology', 'investigatorFullName': 'Ardak Arynov', 'investigatorAffiliation': 'Kazakh Institute of Oncology and Radiology'}}}}