Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage |
Procedure: Red blood cells transfusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- To compare the efficacy of two red blood cells transfusion (RBCT) indicators in decreasing RBCT in a neurocritical care patient population [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
- Number of Red Blood Cell (RBC) transfused [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
- Percentage of transfused patients in each group [ Time Frame: length of stay at intensive care unit ] [ Designated as safety issue: Yes ]
- Sixty days mortality [ Time Frame: hospital stay and 2 months period after the hospital discharge ] [ Designated as safety issue: Yes ]
- Length of intensive care unit (ICU) stay and hospital stay [ Time Frame: hospital stay and 2 months period after the hospital discharge ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
|
Procedure: Red blood cells transfusion
Patients will be transfused (one to one red blood cells unit transfusion)
|
|
Active Comparator: 2
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
Patients will be transfused (one to one red blood cells unit transfusion)
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Santiago R Leal-Noval, MD, PhD | 03455012528 ext 312528 | sramon@cica.es |
| Contact: Victoria Arellano, MD, PhD | 03455012528 ext 312528 | victoria_are_or@hotmail.com |
| Spain | |
| Hospital Universitario "Virgen del Rocío" | Recruiting |
| Seville, Spain, 41013 | |
| Contact: Santiago R Leal-Noval, MD, PhD 0-34-55012528 ext 312528 sramon@cica.es | |
| Contact: Victoria Arellano, MD, PhD 0-34-5012528 ext 312528 victoria_are_or@hotmail.com | |
| Principal Investigator: Santiago R Leal-Noval, MD, PhD | |
| Principal Investigator: | Santiago R Leal-Noval, MD, PhD | Hospital Universitario "Virgen del Rocío", Seville, Spain |
| Study Chair: | 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 Director: | Francisco Murillo, MD, PhD | Hospital Universitario "Virgen del Rocío", Seville, Spain |
| Study Chair: | Manuel Muñoz, Prof, MD, PhD | Prof Transfusion Medicine University of Malaga, Spain |
| Study Chair: | Vicente Padilla, MD | Hospital Universitario Virgen del Rocío |
| Study Chair: | Yael Corcia, MD | Hospital Universitario Virgen del Rocío |
| Study Chair: | Aurelio Cayuela, MD, PhD | Hospital Universitario "Virgen del Rocio" |
More Information
No publications provided
| Responsible Party: | Leal-Noval, Santiago R., Hospitales Universitarios "Virgen del Rocío" |
| ClinicalTrials.gov Identifier: | NCT00566709 History of Changes |
| Other Study ID Numbers: | PI-0157/2006, PI 157/06 |
| Study First Received: | November 29, 2007 |
| Last Updated: | February 5, 2009 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospitales Universitarios Virgen del Rocío:
|
transfusion NIRS cerebral oxygenation |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Brain Injuries Cerebral Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013