Traumatic Brain InjuryPhase 2NCT00566709

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

A Phase 2 study testing Red blood cells transfusion in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
What is being tested?: Red blood cells transfusion
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteSpain
Study dates: Jun 2009to Dec 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario "Virgen del Rocío"
Seville, Seville, 41013

Other trials in Spain

About this study

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.

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
Being tested: Red blood cells transfusion
Keywords: transfusion, NIRS, cerebral oxygenation, red blood cell, near infrared spectroscopy
Medical subject headings: Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Red blood cells transfusionProcedure or surgery
Patients will be transfused (one to one red blood cells unit transfusion)

Study groups in NCT00566709
Study group	Role	What they receive
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%. Receives: 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. Receives: Procedure: Red blood cells transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: duration of the protocol, an average of 15 days
Percentage of Transfused Patients in Each Group
Measured: duration of the protocol, an average of 15 days

Secondary outcomes (4)

Hospital Mortality
Measured: length of the hospital stay, an average of 20 days
Length of Intensive Care Unit (ICU) Stay
Measured: The length of ICU stay, an avarege of 17 days
Long-term Mortality
Measured: 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:
1. death.
2. vegetative status.
3. severe disability.
Measured: At hospital discharge, an average of 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Dec 2009

First posted3 Dec 2007 (estimated)
Study startJun 2009
Primary completionNov 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00566709
Sponsor's protocol ID: PI-0157/2006
Other IDs: PI 157/06
Status last verified: Mar 2016
First submitted: 29 Nov 2007
Last updated: 19 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 41114449
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.
PubMed 28486023

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00566709
Acronym / sponsor ID: PI-0157/2006
Conditions: Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Hemorrhage
Keywords: transfusion, NIRS, cerebral oxygenation, red blood cell, near infrared spectroscopy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
Study start: Jun 2009
Primary completion: Nov 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 3 Dec 2007 (estimated)
Results: Posted 11 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RBCT based on rSO2 value	Experimental	Procedure: Red blood cells transfusionIntervention: 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	Procedure: Red blood cells transfusionIntervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Red blood cells transfusionPatients will be transfused (one to one red blood cells unit transfusion)	Procedure or surgery	RBCT based on hemoglobin level value, RBCT based on rSO2 value

Primary outcome

Number of Units of Packed Red Blood Cell Transfused
Time frame: duration of the protocol, an average of 15 days
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
Time frame: duration of the protocol, an average of 15 days

4 secondary outcomes

Hospital Mortality
Time frame: length of the hospital stay, an average of 20 days
Length of Intensive Care Unit (ICU) Stay
Time frame: The length of ICU stay, an avarege of 17 days
Long-term Mortality
Time frame: 1-year after hospital discharge
Unfavorable Glasgow Outcome Scale (GOS)
Time frame: At hospital discharge, an average of 21 days

Results and safety

Results posted to the registry on 11 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RBCT Based on rSO2 Value	51	46
RBCT Based on Hemoglobin Level Value	51	51

Primary outcome: Number of Units of Packed Red Blood Cell Transfused

Time frame: duration of the protocol, an average of 15 days. Mean (Standard Deviation). Unit: units

Measure	RBCT Based on rSO2 Value n = 46	RBCT Based on Hemoglobin Level Value n = 51
Value	0.9 (1.1)	1.5 (1.4)

RBCT Based on rSO2 Value vs RBCT Based on Hemoglobin Level Value: p = 0.03, t-test, 2 sided

Primary outcome: Percentage of Transfused Patients in Each Group

Time frame: duration of the protocol, an average of 15 days. Number. Unit: percentage of transfused participant

Measure	RBCT Based on rSO2 Value n = 46	RBCT Based on Hemoglobin Level Value n = 51
Value	54.3	70.5

RBCT Based on rSO2 Value vs RBCT Based on Hemoglobin Level Value: p = 0.07, Chi-squared, Corrected

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From admission of the patients into the protocol to the hospital discharge, an avarage 21 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RBCT Based on rSO2 Value	0 of 51 (0%)	0 of 51 (0%)	Not reported
RBCT Based on Hemoglobin Level Value	0 of 51 (0%)	0 of 51 (0%)	Not reported

Limitations and caveats (from the sponsor): Limited adherence to the protocol in the rSO2 arm

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41114449Carson 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.
Derived from this study: PubMed 28486023Leal-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.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Santiago R Leal-Noval, MD, PhD principal investigator

Hospital Universitario "Virgen del Rocío", Seville, Spain

Victoria Arellano, MD, PhD study chair

Hospital Universitario "Virgen del Rocío", Seville, Spain

Rosario Amaya, MD, PhD study chair

Hospital Universitario "Virgen del Rocío", Seville, Spain

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Red blood cells transfusion in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Units of Packed Red Blood Cell Transfused (time frame: duration of the protocol, an average of 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566709, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.