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This clinical trial aims to personalise red blood cell transfusion strategies in the crtitically ill patients. The amount of transfusions needs to be minimised in order to prevent adverse events and organ dysfunctions linked to high amounts of red blood cell transfusions.
The researchers aim to investigate the efficacy and safety of measuring the central venous oxygen saturation (ScvO2) (oxygen content in a venous blood sample taken from a central line) to guide clinicians if transfusion is necessary.
The researchers aim to compare the ScvO2 guided transfusion strategy with transfusion based on the clinician's judgment (taking into consideration the patients' comorbidities and actual vital parameters).
Red blood cell transfusions are routine practice in the management of critically ill patients; 25% of patients treated in the intensive care unit receive a transfusion. Its aim is to restore adequate oxygen delivery to peripheral tissues. Transfusion has numerous potentially harmful effects and significantly increases healthcare costs. International guidelines recommend a restrictive transfusion policy. These recommendations are based on studies that use the hemoglobin level as a transfusion trigger. Hemoglobin level does not provide sufficient information about the balance between oxygen delivery and oxygen consumption, which determines tissue oxygenation. Incorporating a physiological parameter into the transfusion decision-making algorithm may ensure a personalized transfusion strategy. Clear evidence is lacking regarding the usefulness of physiological transfusion triggers in the treatment of anemia in critically ill patients. Case reports and retrospective studies have been published, but no randomized trials have been conducted. Central venous oxygen saturation (ScvOâ‚‚) reflects the balance between oxygen delivery and consumption; its normal physiological range is 70-75%, and a decrease indicates inadequate oxygen delivery and oxygen supply/demand imbalance. Thus, it may serve as a potential physiological trigger for clinicians in personalized transfusion management of hemodynamically stable intensive care patients.
Therefore our aim is to examine the efficacy and safety of an ScvOâ‚‚-guided transfusion trigger compared with clinician decision-based transfusion in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central venous saturation guided transfusion | Experimental | Transfusion will be ordered and administered if ScvO2 is below 70% |
|
| Clinician's decision (without ScvO2) | No Intervention | Transfusion will be ordered and administered based on the treating physician's judgment without the knowledge of ScvO2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of central venous saturation | Diagnostic Test | After randomisation central venous saturation will be measured. If the central venous saturation is below 70%, 1 unit of red blood cells will be transfused. The central venous saturation will be measured post transfusion, and if it is still below 70%, further 1 unit of RBCs will be transfused. Measurements and transfusions continue until ScvO2 reaches 70% or hemoglobin level increases above 9g/dl. If ScvO2 is above 70%, no transfusion will be administered. ScvO2 will be measured again between 4-12 hours after the initial measurement. If it is still above 70%, no transfusion will be administered, and no further measurement will be performed on the given day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of units of red blood cells transfused per patient | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central venous saturation (ScvO2) posttransfusion | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Length of vasopressor requirement | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months | |
| Length of meachanical ventilation | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
Inclusion Criteria:
Patient in medical/surgical/trauma ICU
Hemoglobin level between 7g/dl and 9g/dl
Written informed consent by patient or next of kin
Hemodynamically stable:
Monitored with CVC, arterial catheter, hourly urine output
Respiratorily stable
PiCCO or expert ECHO available within 48hours
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolett Kiss, Dr | Contact | +36204866809 | kiss.nikolett@semmelweis.hu | |
| Zsolt Molnar, Professor | Contact | +36303026668 | molnar.zsolt1@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Marton Papp, Dr | Semmelweis University | Study Chair |
| Caner Turan, Dr | Semmelweis University | Study Chair |
| Dilan Mark Karim, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University, Department of Intensive Therapy | Budapest | 1082 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17650770 | Background | Vallet B, Adamczyk S, Barreau O, Lebuffe G. Physiologic transfusion triggers. Best Pract Res Clin Anaesthesiol. 2007 Jun;21(2):173-81. doi: 10.1016/j.bpa.2007.02.003. | |
| 35610743 | Background | Lu K, Huang Z, Liang S, Pan F, Zhang C, Wei J, Wei H, Wang Y, Liao R, Huang A, Huang Y. A physiology-based trigger score to guide perioperative transfusion of allogeneic red blood cells: A multicentre randomised controlled trial. Transfus Med. 2022 Oct;32(5):375-382. doi: 10.1111/tme.12883. Epub 2022 May 24. |
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Individual participant data underlying the results reported in this study will be made available after de-identification. The data will include demographic characteristics, baseline measures, outcomes, and relevant study variables necessary to reproduce the findings.
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Data will be shared with qualified researchers who provide a methodologically sound proposal. Access will be granted following review and approval by the study institution, and after signing a data sharing agreement.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| Incidence of end-organ failure | Newly developed end-organ dysfunction and failure i.e: bowel ischaemia, acute kindney injury, stroke, AMI | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Incidence of infective complications | Incidence of VAP, CLABSI, UTI, wound infection | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Length of intensive care unit stay | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Length of hospital stay | From enrollment to the discharge from the hospital or date of death at the hospital, whichever came first, assessed up to 12 months |
| Change in CO2-gap post transfusion | From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months |
| Semmelweis University |
| Study Chair |
| Laszlo Zubek, Dr | Semmelweis University | Study Chair |
| North-Pest Central Hospital- Hungarian Defense Forces Medical Center, Department of Anaesthesiology and Intensive Therapy | Budapest | 1134 | Hungary |
|
| 37824153 | Background | Carson JL, Stanworth SJ, Guyatt G, Valentine S, Dennis J, Bakhtary S, Cohn CS, Dubon A, Grossman BJ, Gupta GK, Hess AS, Jacobson JL, Kaplan LJ, Lin Y, Metcalf RA, Murphy CH, Pavenski K, Prochaska MT, Raval JS, Salazar E, Saifee NH, Tobian AAR, So-Osman C, Waters J, Wood EM, Zantek ND, Pagano MB. Red Blood Cell Transfusion: 2023 AABB International Guidelines. JAMA. 2023 Nov 21;330(19):1892-1902. doi: 10.1001/jama.2023.12914. |
| 37824112 | Background | Raasveld SJ, de Bruin S, Reuland MC, van den Oord C, Schenk J, Aubron C, Bakker J, Cecconi M, Feldheiser A, Meier J, Muller MCA, Scheeren TWL, McQuilten Z, Flint A, Hamid T, Piagnerelli M, Tomic Mahecic T, Benes J, Russell L, Aguirre-Bermeo H, Triantafyllopoulou K, Chantziara V, Gurjar M, Myatra SN, Pota V, Elhadi M, Gawda R, Mourisco M, Lance M, Neskovic V, Podbregar M, Llau JV, Quintana-Diaz M, Cronhjort M, Pfortmueller CA, Yapici N, Nielsen ND, Shah A, de Grooth HJ, Vlaar APJ; InPUT Study Group. Red Blood Cell Transfusion in the Intensive Care Unit. JAMA. 2023 Nov 21;330(19):1852-1861. doi: 10.1001/jama.2023.20737. |
| D013568 | Pathological Conditions, Signs and Symptoms |