Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury (NIRSTBI)
|ClinicalTrials.gov Identifier: NCT01728831|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : December 3, 2015
|Condition or disease|
|TBI (Traumatic Brain Injury) Acute Brain Injuries|
While there are studies that have invasively monitored cerebral saturation and brain tissue oxygen in severe traumatic brain injury (sTBI) patients, there are none using non-invasive cerebral saturation monitoring in TBI patients undergoing packed red blood cell (pRBC) transfusion. To date, all published studies have involved invasive monitoring with their concomitant potential side effects. Insertion of invasive probes and monitors has several risks and side effects including bleeding, local trauma and brain damage, and infection. Furthermore, they have limited utility as information is restricted to the region of the brain surrounding the probe, as opposed to a more global picture. We therefore propose an observational study using non-invasive near infrared spectroscopy to monitor brain tissue oxygen during the transfusion of packed red blood cells.
• Improved oxygen delivery causes improved brain tissue oxygen saturation.
• The transfusion of packed red blood cells resulting in a change in the hemoglobin in the 70- 100g/L range, will be associated with an increase in cerebral tissue oxygen saturation measured by near infrared spectroscopy in severe traumatic brain injured patients.
• Evaluate the applicability of a 4 wavelength near-infrared spectroscopy (NIRS) to monitor the cerebral oximetry in traumatic brain injury patients. Observe the trend of cerebral tissue oxygenation saturations (StO2) before, during and after a blood transfusion in TBI patients.
- We hypothesize that as pRBCs are transfused there will be a plateau (i.e. hemoglobin threshold) beyond which no increase in cerebral tissue oxygenation will occur.
- There will be lag time between the increase in systemic hemoglobin and the improvement of cerebral tissue oxygenation.
- To correlate the systemic hemoglobin level with cerebral tissue oxygenation saturation as pRBCs are transfused.
- Correlation of non-invasive cerebral tissue oxygenation saturation measurements with invasive brain tissue oxygen tension (if available).
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Observational Study of Cerebral Tissue Oxygen Saturation During Blood Transfusion in Severe Traumatic Brain Injured Patients|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||November 2015|
- Applicability of a 4 wavelength near-infrared spectroscopy (NIRS) to monitor the CHANGE in absolute cerebral oximetry over time [ Time Frame: Compare the change from the start of the transfusion until 10 hours later. ]After the physician in charge for the patient decides a PRBC transfusion is needed, the FORE-SIGHT probe will be placed on the patient's forehead. A single PRBC unit will be transfused over 30 - 60 minutes. Recording will be started 60 minutes before the transfusion and continued for up to 10 hours after the PRBC unit.
- The impact of PRBC transfusion on absolute cerebral oximetry compared to peripheral values over time. [ Time Frame: Level of hemoglobin and hematocrit on admission, before transfusion and hourly after the transfusion for up to 5 hours ]Blood specimens (2-4 ml each every 30-60 minutes up to 5 hours) will be drawn concurrently with the routine blood work ordered by the clinical team. The additional blood work will be drawn from an arterial line or central line already in place so no needles will be used, thus minimizing the risk further.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728831
|St Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Study Director:||Andrew Baker, MD||Medical Director, Critical Care|
|Principal Investigator:||Victoria A McCredie, MBChB||Sunnybrook Health Sciences Center, University of Toronto|