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

Traumatic Brain Injury Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566709
• Other study ID #: PI-0157/2006
• Secondary ID: PI 157/06
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2007
• Last updated: February 12, 2016
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2016
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Procedure:
• Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)

Locations

Country	Name	City	State
Spain	Hospital Universitario "Virgen del Rocío"	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	duration of the protocol, an average of 15 days	No
Primary	Percentage of Transfused Patients in Each Group		duration of the protocol, an average of 15 days	No
Secondary	Hospital Mortality		length of the hospital stay, an average of 20 days	Yes
Secondary	Length of Intensive Care Unit (ICU) Stay		The length of ICU stay, an avarege of 17 days	Yes
Secondary	Long-term Mortality		1-year after hospital discharge	Yes
Secondary	Unfavorable Glasgow Outcome Score (GOS)	GOS measures the degree of disability associated with the brain injury Unfavorable GOS included the categories of severe disability, vegetative status, and death.	At hospital discharge, an average of 21 days	Yes