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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
PSI Foundation inc
Information provided by (Responsible Party):
Dr. Andrew Baker, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01728831
First received: November 4, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
TBI (Traumatic Brain Injury)
Acute Brain Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Cerebral Tissue Oxygen Saturation During Blood Transfusion in Severe Traumatic Brain Injured Patients

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728831

Contacts
Contact: Jana Suresh, MD 416-864-6060 ext 669 sureshj@smh.ca
Contact: Victoria A McCredie, MBChB 416 480 6100 ext 1671 victoria.mccredie@sunnybrook.ca

Locations
Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Andrew Baker, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
PSI Foundation inc
Investigators
Study Director: Andrew Baker, MD Medical Director, Critical Care
Principal Investigator: Victoria A McCredie, MBChB Sunnybrook Health Sciences Center, University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Andrew Baker, Medical Director, Critical Care, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01728831     History of Changes
Other Study ID Numbers: 11-294
Study First Received: November 4, 2012
Last Updated: December 18, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Red Cell Transfusion
Cerebral tissue oxygenation
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 20, 2014