St Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
NCT Number: NCT01728831
This proposal aims to provide some objective, non-invasively achieved, physiologically relevant data in order to provide some rational basis for decision-making for transfusion in sTBI. Specifically this proposal is an observational study of transfusion and brain tissue saturation in sTBI patients. The results will illustrate to what degree brain tissue oxygenation is critically dependent on the degree of anemia in sTBI and help in the decision of whether transfusion might be helpful.
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Notify Me18 year–80 year
All sexes
Observational
Toronto, Ontario, M5B 1W8, Canada
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.
Primary Hypothesis:
Testable Hypothesis:
Primary Aims:
Secondary Hypothesis:
Secondary Aims:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Unity Health Toronto
Other
Observational Study of Cerebral Tissue Oxygen Saturation During Blood Transfusion in Severe Traumatic Brain Injured Patients
Acronym: NIRSTBI
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