Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury (NIRSTBI)

December 1, 2015 updated by: Unity Health Toronto

Observational Study of Cerebral Tissue Oxygen Saturation During Blood Transfusion in Severe Traumatic Brain Injured Patients

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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:

• Improved oxygen delivery causes improved brain tissue oxygen saturation.

Testable Hypothesis:

• 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.

Primary Aims:

• 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.

Secondary Hypothesis:

  • 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.

Secondary Aims:

  • 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

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

30 Patient with clinical diagnosis of severe TBI and GCS <9 and Age > 18 years old

Description

Inclusion Criteria:

  1. Age > 18 years old
  2. Patient with clinical diagnosis of severe TBI and GCS <9
  3. Patient requiring PRBC transfusion with a qualifying Hb< 10/dL

Exclusion Criteria:

  1. Inability to place the NIRS probes on the patients (facial fractures, facial laceration, etc.).
  2. Deficient signal of SctO2 impeding its proper valuation
  3. Active coronary ischemia as judged by dynamic ischemic ECG changes and/ or positive troponin levels not due to myocardial contusion.

  4. Active hemorrhage: Example

    1. Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolization
    2. Pelvic fracture likely to require surgery +/- embolization
    3. More than two long bone fractures requiring operative fixation
  5. Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
  6. Systolic BP <90mmHg
  7. Heart rate > 120bpm
  8. GCS=3 + un-reactive pupils

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Compare the change from the start of the transfusion until 10 hours later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Level of hemoglobin and hematocrit on admission, before transfusion and hourly after the transfusion for up to 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Study Director: Andrew Baker, MD, Medical Director, Critical Care
  • Principal Investigator: Victoria A McCredie, MBChB, Sunnybrook Health Sciences Center, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (ESTIMATE)

November 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-294

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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