Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141674
Status:
COMPLETED
Last Update Posted:
2008-09-04
First Post:
2005-08-30
Brief Title:
Age of Blood in Brain Injury
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 gl 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
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 gl 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VCHRI V04-0261 | None | None | None |