Traumatic Brain InjuryNCT00141674
Age of Blood in Brain Injury
A study testing Blood Transfusion in people with Traumatic Brain Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
Donated red blood cells vary in how old they are, that is, how long they have been stored since being collected from donors. Blood that has been donated is stored for a maximum of 42 days, after this time it is expired. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Blood Transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Dec 2007
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary traumatic brain injury
- Glasgow Coma Scale < 8
- Invasive neurological monitoring:
- External Ventricular Drain
- Jugular bulb catheter
- Hemoglobin < 100 g/L and decision has been made by Attending Physician to treat with one unit pRBC
Who cannot join
- Age < 16
- Ongoing need for blood products
- Received Packed Red Blood Cells within preceding 24 hours
- Multiple trauma necessitating ongoing resuscitation
- Pregnant patients
- Chronic renal failure
Show all 10Show fewer
- Severe sepsis or septic shock
- Adult respiratory distress syndrome or acute lung injury
- Presumed unstable neurological status during course of study
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial Comparing the Effects of Fresh vs. Old Blood on Cerebral Oxygen Extraction in Patients With Traumatic Brain Injuries
Donated red blood cells vary in how old they are, that is, how long they have been stored since being collected from donors. Blood that has been donated is stored for a maximum of 42 days, after this time it is expired. That means that red blood cells that are given to patients as a blood transfusion can be anywhere from a few days old to 42 days old. The average age of blood that is given as a blood transfusion in this hospital is 21 days old.
As stored blood gets older its ability to carry oxygen may be reduced. Whether or not this is important in patients with a brain injury is not currently known.
The purpose of this study is to try and determine if fresh blood (less than 5 days old) is better than old blood (greater than 20 days old) in improving the supply of oxygen in patients who have suffered an injury to their brain.
Read the detailed description
PURPOSE
To demonstrate that packed red blood cells (pRBC) less than 5 days old are superior to older (>20days) blood in improving markers of cerebral oxygenation in acutely head injured patients.
HYPOTHESIS
Transfusion of pRBC will result in increased cerebral extraction of oxygen. This effect will be greatest in pRBC stored for a greater length of time.
JUSTIFICATION
One of the main aims of the intensive management of head injured patients is the prevention of secondary hypoxic or hypotensive insults in the already injured brain. Packed red blood cell transfusions are commonly given to trauma patients suffering anemia (Hgb <100 g/l) secondary to blood loss in order to improve oxygen delivery to vital organs including the brain.
Previous studies have shown that the capacity of packed red blood cells (pRBC) to improve oxygen delivery to tissues diminishes with increased time in storage. This storage lesion may improve with time post transfusion; however, this may take many hours.
Other studies have shown an association between age of pRBCs transfused and length of stay in trauma patients and mortality in septic ICU patients. Unused old blood is likely to be sent to high volume centers to avoid wasting a precious resource.
The effects of 'old' transfused blood have not been subject to rigorous prospective studies and age of blood has not been shown to be causally related to the adverse outcomes mentioned above, hence the need for further studies.
The injured brain is uniquely sensitive to further damage. Even a brief secondary insult of either hypotension or hypoxia has been shown to have a significant adverse effect on outcomes including permanent disability and death. Furthermore the measurement of markers of cerebral oxygenation forms part of the standard care of severely head injured patients in this institution giving a unique opportunity to study the effects of blood transfusion in this group of patients.
The presence of a storage lesion in pRBCs lasting even a few hours could have a significant impact on the head injured patient. If indeed 'fresh' blood does significantly improve markers of cerebral oxygenation when compared to older blood it could alter clinical practice significantly by placing a priority on transfusing only 'fresh' blood in such patients. The effect of age of pRBCs has never been studied in the head injured population.
Donated blood is stored for a maximum of 42 days. The average age of pRBC administered at VGH is 21 days.
OBJECTIVES
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) pRBC on cerebral oxygen extraction. We will also evaluate the effect of transfusion of pRBC on cerebral oxygen extraction in patients with traumatic brain injury.
RESEARCH METHOD
This is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study.
- Conditions
- Traumatic Brain Injury
- Being tested
- Blood Transfusion
- Keywords
- Blood transfusion, Age of blood, Traumatic Brain Injury, Cerebral Oxygen Extraction Ratio, Age of transfused blood in traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TransfusionProcedure or surgery
This is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) packed red blood cells (pRBC) on cerebral oxygen extraction ratio for 24 hours post transfusion
Measured: 20 days
Secondary outcomes (1)
To evaluate the effect of transfusion of pRBC on cerebral oxygen extraction in patients with traumatic brain injury for 24 hours post transfusion.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Dean Chittock, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141674
- Sponsor's protocol ID
- C04-0459
- Other IDs
- VCHRI #V04-0261
- Status last verified
- Sep 2008
- First submitted
- 30 Aug 2005
- Last updated
- 4 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing the Effects of Fresh vs. Old Blood on Cerebral Oxygen Extraction in Patients With Traumatic Brain Injuries
- ClinicalTrials.gov ID
- NCT00141674
- Acronym / sponsor ID
- C04-0459
- Conditions
- Traumatic Brain Injury
- Keywords
- Blood transfusion, Age of blood, Traumatic Brain Injury, Cerebral Oxygen Extraction Ratio, Age of transfused blood in traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Sep 2005 (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.
Donated red blood cells vary in how old they are, that is, how long they have been stored since being collected from donors. Blood that has been donated is stored for a maximum of 42 days, after this time it is expired. That means that red blood cells that are given to patients as a blood transfusion can be anywhere from a few days old to 42 days old. The average age of blood that is given as a blood transfusion in this hospital is 21 days old.
As stored blood gets older its ability to carry oxygen may be reduced. Whether or not this is important in patients with a brain injury is not currently known.
The purpose of this study is to try and determine if fresh blood (less than 5 days old) is better than old blood (greater than 20 days old) in improving the supply of oxygen in patients who have suffered an injury to their brain.
Detailed description
PURPOSE
To demonstrate that packed red blood cells (pRBC) less than 5 days old are superior to older (>20days) blood in improving markers of cerebral oxygenation in acutely head injured patients.
HYPOTHESIS
Transfusion of pRBC will result in increased cerebral extraction of oxygen. This effect will be greatest in pRBC stored for a greater length of time.
JUSTIFICATION
One of the main aims of the intensive management of head injured patients is the prevention of secondary hypoxic or hypotensive insults in the already injured brain. Packed red blood cell transfusions are commonly given to trauma patients suffering anemia (Hgb <100 g/l) secondary to blood loss in order to improve oxygen delivery to vital organs including the brain.
Previous studies have shown that the capacity of packed red blood cells (pRBC) to improve oxygen delivery to tissues diminishes with increased time in storage. This storage lesion may improve with time post transfusion; however, this may take many hours.
Other studies have shown an association between age of pRBCs transfused and length of stay in trauma patients and mortality in septic ICU patients. Unused old blood is likely to be sent to high volume centers to avoid wasting a precious resource.
The effects of 'old' transfused blood have not been subject to rigorous prospective studies and age of blood has not been shown to be causally related to the adverse outcomes mentioned above, hence the need for further studies.
The injured brain is uniquely sensitive to further damage. Even a brief secondary insult of either hypotension or hypoxia has been shown to have a significant adverse effect on outcomes including permanent disability and death. Furthermore the measurement of markers of cerebral oxygenation forms part of the standard care of severely head injured patients in this institution giving a unique opportunity to study the effects of blood transfusion in this group of patients.
The presence of a storage lesion in pRBCs lasting even a few hours could have a significant impact on the head injured patient. If indeed 'fresh' blood does significantly improve markers of cerebral oxygenation when compared to older blood it could alter clinical practice significantly by placing a priority on transfusing only 'fresh' blood in such patients. The effect of age of pRBCs has never been studied in the head injured population.
Donated blood is stored for a maximum of 42 days. The average age of pRBC administered at VGH is 21 days.
OBJECTIVES
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) pRBC on cerebral oxygen extraction. We will also evaluate the effect of transfusion of pRBC on cerebral oxygen extraction in patients with traumatic brain injury.
RESEARCH METHOD
This is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with primary traumatic brain injury
- Glasgow Coma Scale < 8
- Invasive neurological monitoring:
- Hemoglobin < 100 g/L and decision has been made by Attending Physician to treat with one unit pRBC
Key exclusion criteria (10 listed)
- Age < 16
- Ongoing need for blood products
- Received Packed Red Blood Cells within preceding 24 hours
- Multiple trauma necessitating ongoing resuscitation
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood TransfusionThis is a single centre randomized trial in severely head injured patients requiring a blood transfusion. Randomization will be by computer generated random numbers paced in sealed envelopes. Patients would be randomized to receive either blood less than 5 days old or greater than 20 days old. The decision to transfuse and all other intensive care management will be unaltered by enrolment in the study. | Procedure or surgery | – |
Primary outcome
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) packed red blood cells (pRBC) on cerebral oxygen extraction ratio for 24 hours post transfusion
Time frame: 20 days
1 secondary outcome
To evaluate the effect of transfusion of pRBC on cerebral oxygen extraction in patients with traumatic brain injury for 24 hours post transfusion.
Time frame: 24 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 4 Sep 2008.
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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.
Dean Chittock, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Transfusion in people with Traumatic Brain Injury, run by University of British Columbia 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 6 inclusion and 10 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 4 Sep 2008. 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?
To evaluate the effect of transfusing "fresh" (blood stored less than 5 days) versus "stored" (blood stored for greater than 20 days) packed red blood cells (pRBC) on cerebral oxygen extraction ratio for 24 hours post transfusion (time frame: 20 days). 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 4 Sep 2008.