Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Primary Purpose
Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Red blood cells transfusion
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring transfusion, NIRS, cerebral oxygenation, red blood cell, near infrared spectroscopy
Eligibility Criteria
Inclusion Criteria:
- Severe traumatic brain injury (Glasgow coma scale < 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
- Moderate anemia. Hemoglobin levels > 7 g/dL and < 10 g/dL
- Hemodynamical stability (mean arterial pressure > 75 mm Hg)
- Respiratory stability (PaO2 / FiO2 ratio > 220)
- Expected length of ICU stay > 3 days
Exclusion Criteria:
- Patient's relatives' refusal to patient's inclusion in the study
- Active bleeding
- Ongoing need for blood products
- Patients necessitating ongoing resuscitation
- End-stage in which death is imminent
- Antecedents of angina or myocardial infarction (poor cardiopulmonary reserve)
- Deficient signal of rSO2 impeding its proper valuation
Sites / Locations
- Hospital Universitario "Virgen del Rocío"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RBCT based on rSO2 value
RBCT based on hemoglobin level value
Arm Description
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
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.
Outcomes
Primary Outcome Measures
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
Percentage of Transfused Patients in Each Group
Secondary Outcome Measures
Hospital Mortality
Length of Intensive Care Unit (ICU) Stay
Long-term Mortality
Unfavorable Glasgow Outcome Scale (GOS)
GOS measures the degree of disability associated with the brain injury
Unfavorable GOS included the categories of:
death.
vegetative status.
severe disability.
Full Information
NCT ID
NCT00566709
First Posted
November 29, 2007
Last Updated
March 21, 2016
Sponsor
Hospitales Universitarios Virgen del Rocío
1. Study Identification
Unique Protocol Identification Number
NCT00566709
Brief Title
Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Official Title
Phase II Study of Usefulness of Near Infrared Spectroscopy to Optimize Red Blood Cells Transfusion in Neuro Critical Ill Patients With Severe Traumatic Brain Injury, Subarachnoid Hemorrhage or Intracerebral Hemorrhage.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitales Universitarios Virgen del Rocío
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
Keywords
transfusion, NIRS, cerebral oxygenation, red blood cell, near infrared spectroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RBCT based on rSO2 value
Arm Type
Experimental
Arm Description
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Arm Title
RBCT based on hemoglobin level value
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Red blood cells transfusion
Intervention Description
Patients will be transfused (one to one red blood cells unit transfusion)
Primary Outcome Measure Information:
Title
Number of Units of Packed Red Blood Cell Transfused
Description
Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol
Time Frame
duration of the protocol, an average of 15 days
Title
Percentage of Transfused Patients in Each Group
Time Frame
duration of the protocol, an average of 15 days
Secondary Outcome Measure Information:
Title
Hospital Mortality
Time Frame
length of the hospital stay, an average of 20 days
Title
Length of Intensive Care Unit (ICU) Stay
Time Frame
The length of ICU stay, an avarege of 17 days
Title
Long-term Mortality
Time Frame
1-year after hospital discharge
Title
Unfavorable Glasgow Outcome Scale (GOS)
Description
GOS measures the degree of disability associated with the brain injury
Unfavorable GOS included the categories of:
death.
vegetative status.
severe disability.
Time Frame
At hospital discharge, an average of 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe traumatic brain injury (Glasgow coma scale < 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
Moderate anemia. Hemoglobin levels > 7 g/dL and < 10 g/dL
Hemodynamical stability (mean arterial pressure > 75 mm Hg)
Respiratory stability (PaO2 / FiO2 ratio > 220)
Expected length of ICU stay > 3 days
Exclusion Criteria:
Patient's relatives' refusal to patient's inclusion in the study
Active bleeding
Ongoing need for blood products
Patients necessitating ongoing resuscitation
End-stage in which death is imminent
Antecedents of angina or myocardial infarction (poor cardiopulmonary reserve)
Deficient signal of rSO2 impeding its proper valuation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago R Leal-Noval, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Arellano, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rosario Amaya, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio M Puppo, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carmen M Ferrándiz, MD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antonio J Marín, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francisco Murillo, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocío", Seville, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuel Muñoz, Prof, MD, PhD
Organizational Affiliation
Prof Transfusion Medicine University of Malaga, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vicente Padilla, MD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yael Corcia, MD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aurelio Cayuela, MD, PhD
Organizational Affiliation
Hospital Universitario "Virgen del Rocio"
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario "Virgen del Rocío"
City
Seville
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
28486023
Citation
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.
Results Reference
derived
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Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
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