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| ID | Type | Description | Link |
|---|---|---|---|
| PI 157/06 |
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Neurocritical ill patients are frequently transfused. Red blood cell transfusion (RBCT) in these patients has been associated with deleterious effects, including higher rates of nosocomial infections, multi-organ failure, and mortality. Therefore, it seems crucial to avoid any unnecessary RBCT.
Most critically ill patients tolerate hemoglobin levels near 7 g/dL without an increase in morbidity or mortality rates. In this regard, a recent sub-analysis of TRICC trial has showed that TBI patients may tolerate hemoglobin levels as low as 7 g/dL, but other studies including neurocritical patients suggested that severe anemia may worsen clinical outcome. Therefore, optimal hemoglobin levels in neurocritical care patients remain largely unknown. Some textbooks and guidelines recommend to transfuse these patients to reach hemoglobin levels near to 10 g/dL, despite the lack of a solid scientific background supporting this target.
Even though it has not been demonstrated, hemoglobin-based RBCT prescription could result in over- or under-transfusion in neurocritical patients. Alternatively, it has been suggested that more physiological transfusion triggers, using direct signals coming from the brain, will progressively replace arbitrary hemoglobin-based transfusion triggers in the neurocritical patients [65]. At the neurocritical units, patients are often monitored by using non-invasive methods, such as near infrared spectroscopy which indirectly measures regional cerebral oxygen saturation (rSO2). Changes in rSO2 values have been shown to directly correlate with changes in erythrocyte mass, thus increasing with RBCT and decreasing with blood losses. Moreover, rSO2 values also show a good correlation with clinical outcome and other variables which are often monitored in TBI patients.
The purpose of this study is to ascertain as to whether rSO2 levels are more efficacious than conventional hemoglobin levels in guiding RBCT in patients admitted to a neurocritical care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBCT based on rSO2 value | Experimental | Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%. |
|
| RBCT based on hemoglobin level value | Active Comparator | Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cells transfusion | Procedure | Patients will be transfused (one to one red blood cells unit transfusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Units of Packed Red Blood Cell Transfused | Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol | duration of the protocol, an average of 15 days |
| Percentage of Transfused Patients in Each Group | duration of the protocol, an average of 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Mortality | length of the hospital stay, an average of 20 days | |
| Length of Intensive Care Unit (ICU) Stay | The length of ICU stay, an avarege of 17 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago R Leal-Noval, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Principal Investigator |
| Victoria Arellano, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Chair |
| Rosario Amaya, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Chair |
| Antonio M Puppo, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Chair |
| Carmen M Ferrándiz, MD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Chair |
| Antonio J MarÃn, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Chair |
| Francisco Murillo, MD, PhD | Hospital Universitario "Virgen del RocÃo", Seville, Spain | Study Director |
| Manuel Muñoz, Prof, MD, PhD | Prof Transfusion Medicine University of Malaga, Spain | Study Chair |
| Vicente Padilla, MD | Hospitales Universitarios Virgen del RocÃo |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario "Virgen del RocÃo" | Seville | Seville | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 28486023 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | RBCT Based on rSO2 Value | Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) |
| FG001 | RBCT Based on Hemoglobin Level Value | Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patient included into to "Intention to treat" analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | RBCT Based on rSO2 Value | Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) |
| BG001 | RBCT Based on Hemoglobin Level Value |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Units of Packed Red Blood Cell Transfused | Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol | Posted | Mean | Standard Deviation | units | duration of the protocol, an average of 15 days |
|
From admission of the patients into the protocol to the hospital discharge, an avarage 21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RBCT Based on rSO2 Value | Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) |
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Limited adherence to the protocol in the rSO2 arm
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santiago R Leal-Noval, MD, PhD | University Hospital "Virgen del RocÃo" | 0034954012528 | srlealnoval@gmail.com |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Long-term Mortality |
| 1-year after hospital discharge |
| Unfavorable Glasgow Outcome Scale (GOS) | GOS measures the degree of disability associated with the brain injury Unfavorable GOS included the categories of:
| At hospital discharge, an average of 21 days |
| Study Chair |
| Yael Corcia, MD | Hospitales Universitarios Virgen del RocÃo | Study Chair |
| Aurelio Cayuela, MD, PhD | Hospitales Universitarios Virgen del RocÃo | Study Chair |
| Leal-Noval SR, Arellano-Orden V, Munoz-Gomez M, Cayuela A, Marin-Caballos A, Rincon-Ferrari MD, Garcia-Alfaro C, Amaya-Villar R, Casado-Mendez M, Dusseck R, Murillo-Cabezas F. Red Blood Cell Transfusion Guided by Near Infrared Spectroscopy in Neurocritically Ill Patients with Moderate or Severe Anemia: A Randomized, Controlled Trial. J Neurotrauma. 2017 Sep;34(17):2553-2559. doi: 10.1089/neu.2016.4794. Epub 2017 Jul 19. |
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Hemoglobin (g/L) | Mean | Standard Deviation | g/L |
|
| Arterial Hypertension (n) | Number | participants |
|
| Diabetes mellitus (n) | Number | participants |
|
| APACHE II score | Acute Physiology and Chronic Health Evaluation (APACHE) II score Minimun score:0, Maximum score: 71 Higher values represent worse result. | Mean | Standard Deviation | units on a scale |
|
| GCS | Glasgow Coma Scale Minimun: 3; Maximum: 15 Higher values represent better outcome | Median | Inter-Quartile Range | units on a scale |
|
| ISS score (N=30, 27) | Injury severity score (ISS) Minimum: 0; maximum: 75 Higher values represent worse outcome ISS is only collected in patients with traumatic brain injury (N=57)
| Mean | Standard Deviation | units on a scale |
|
| Hunt and Hess scale (N=10, 13) | Hunt and Hess scale for assessing the severity of patients with subarachnoid hemorrhage Minimum: 1; Maximum: 5 Higher values represent worse outcome Only 23 patients with subarachnoid hemorrhage are included.
| Mean | Standard Deviation | units on a scale |
|
| Fisher scale (N=10, 13) | Computer tomography Fisher Scale Minimum: 1; Maximum: 4 Higher values represent worse outcome Only 23 patients with subarachnoid hemorrhage are included
| Mean | Standard Deviation | units on a scale |
|
| Modified Grab score (N=11, 11) | Modified Graeb score for intra cerebral hemorrhage Minimum: 0; maximum: 42. Higher values represent worse outcome Only 22 patients with intra cerebral hemorrhage are included
| Mean | Standard Deviation | units on a scale |
|
| PbrO2 (mm Hg) (N=17, 22) | Pressure brain regional oxygen: PbrO2 Only 39 patients monitored with a PbrO2 probe are included:
| Mean | Standard Deviation | mm Hg |
|
| CPP (mm Hg) (N=17, 22) | Cerebral perfusion pressure (CPP) Only 39 patients monitored with a PbrO2 probe are included:
| Mean | Standard Deviation | mm Hg |
|
| Diagnosis | Number | participants |
|
|
|
|
| Primary | Percentage of Transfused Patients in Each Group | Posted | Number | percentage of transfused participant | duration of the protocol, an average of 15 days |
|
|
|
|
| Secondary | Hospital Mortality | Posted | Number | participants | length of the hospital stay, an average of 20 days |
|
|
|
|
| Secondary | Length of Intensive Care Unit (ICU) Stay | Posted | Mean | Standard Deviation | days | The length of ICU stay, an avarege of 17 days |
|
|
|
|
| Secondary | Long-term Mortality | Posted | Number | participants | 1-year after hospital discharge |
|
|
|
|
| Secondary | Unfavorable Glasgow Outcome Scale (GOS) | GOS measures the degree of disability associated with the brain injury Unfavorable GOS included the categories of:
| Posted | Number | participants | At hospital discharge, an average of 21 days |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | RBCT Based on Hemoglobin Level Value | Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL. Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion) | 0 | 51 | 0 | 51 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |