TBI (Traumatic Brain Injury)NIRSTBINCT01728831
Study of Cerebral Tissue Oxygenation During Transfusion in Traumatic Brain Injury
An observational study of TBI (Traumatic Brain Injury) and Acute Brain Injuries, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Acute Brain Injuries
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 Patient with clinical diagnosis of severe TBI and GCS <9 and Age > 18 years old
Who may be able to join
- Age > 18 years old
- Patient with clinical diagnosis of severe TBI and GCS <9
- Patient requiring PRBC transfusion with a qualifying Hb< 10/dL
Who cannot join
- Inability to place the NIRS probes on the patients (facial fractures, facial laceration, etc.).
- Deficient signal of SctO2 impeding its proper valuation
- Active coronary ischemia as judged by dynamic ischemic ECG changes and/ or positive troponin levels not due to myocardial contusion.
- Active hemorrhage: Example
- Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolization
- Pelvic fracture likely to require surgery +/- embolization
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- More than two long bone fractures requiring operative fixation
- Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
- Systolic BP <90mmHg
- Heart rate > 120bpm
- GCS=3 + un-reactive pupils
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- TBI (Traumatic Brain Injury), Acute Brain Injuries
- Keywords
- Red Cell Transfusion, Cerebral tissue oxygenation, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Applicability of a 4 wavelength near-infrared spectroscopy (NIRS) to monitor the CHANGE in absolute cerebral oximetry over time
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.
Measured: Compare the change from the start of the transfusion until 10 hours later.
Secondary outcomes (1)
The impact of PRBC transfusion on absolute cerebral oximetry compared to peripheral values over time.
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.
Measured: Level of hemoglobin and hematocrit on admission, before transfusion and hourly after the transfusion for up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Baker, MD, Study director, Medical Director, Critical CareVictoria A McCredie, MBChB, Principal investigator, Sunnybrook Health Sciences Center, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728831
- Sponsor's protocol ID
- 11-294
- Acronym
- NIRSTBI
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cerebral Tissue Oxygen Saturation During Blood Transfusion in Severe Traumatic Brain Injured Patients
- ClinicalTrials.gov ID
- NCT01728831
- Acronym / sponsor ID
- NIRSTBI / 11-294
- Conditions
- TBI (Traumatic Brain Injury), Acute Brain Injuries
- Keywords
- Red Cell Transfusion, Cerebral tissue oxygenation, Traumatic brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 Patient with clinical diagnosis of severe TBI and GCS <9 and Age > 18 years old
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patient with clinical diagnosis of severe TBI and GCS <9
- Patient requiring PRBC transfusion with a qualifying Hb< 10/dL
Key exclusion criteria (11 listed)
- Inability to place the NIRS probes on the patients (facial fractures, facial laceration, etc.).
- Deficient signal of SctO2 impeding its proper valuation
- Active coronary ischemia as judged by dynamic ischemic ECG changes and/ or positive troponin levels not due to myocardial contusion.
- Active hemorrhage: Example
- Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Baker, MD study director
Medical Director, Critical Care
Victoria A McCredie, MBChB principal investigator
Sunnybrook Health Sciences Center, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TBI (Traumatic Brain Injury) and Acute Brain Injuries, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.