Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients

NCT00566709 | Completed Phase 2 Results DMC

• 2 other identifiers: PI-0157/2006PI 157/06
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracerebral Hemorrhage

Keywords

transfusion; NIRS; cerebral oxygenation; red blood cell; near infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

• Long-term Mortality

  1-year after hospital discharge

• Unfavorable Glasgow Outcome Scale (GOS)

  At hospital discharge, an average of 21 days

Study Arms (2)

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%.

Procedure: Red blood cells transfusion

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.

Procedure: Red blood cells transfusion

Interventions

Red blood cells transfusion PROCEDURE

Patients will be transfused (one to one red blood cells unit transfusion)

RBCT based on hemoglobin level value; RBCT based on rSO2 value

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario "Virgen del Rocío"

Seville, Seville, 41013, Spain

Location

Related Publications (2)

• 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.

  PMID: 41114449 DERIVED

• 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.

  PMID: 28486023 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limited adherence to the protocol in the rSO2 arm

Results Point of Contact

• Title: Santiago R Leal-Noval, MD, PhD
• Organization: University Hospital "Virgen del Rocío"

srlealnoval@gmail.com

0034954012528

Study Officials

• Santiago R Leal-Noval, MD, PhD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  PRINCIPAL INVESTIGATOR

• Victoria Arellano, MD, PhD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  STUDY CHAIR

• Rosario Amaya, MD, PhD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  STUDY CHAIR

• Antonio M Puppo, MD, PhD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  STUDY CHAIR

• Carmen M Ferrándiz, MD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  STUDY CHAIR

• Antonio J Marín, MD, PhD

  Hospital Universitario "Virgen del Rocío", Seville, Spain

  STUDY CHAIR

• Francisco Murillo, MD, PhD

  Hospital Universitario "Virgen del Rocío", 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 Rocío

  STUDY CHAIR

• Yael Corcia, MD

  Hospitales Universitarios Virgen del Rocío

  STUDY CHAIR

• Aurelio Cayuela, MD, PhD

  Hospital Universitario Virgen del Rocio

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Santiago R. Leal-Noval, MD Ph.D

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 19, 2016
• Results First Posted: March 11, 2016

Record last verified: 2016-03

Locations

ES (1)