Age of Blood in Brain Injury - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00141674

Purpose

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.

Condition	Intervention
Traumatic Brain Injury	Procedure: Blood Transfusion

MedlinePlus related topics: Blood Transfusion and Donation Traumatic Brain Injury

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment
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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with primary traumatic brain injury
Glasgow Coma Scale < 8
Invasive neurological monitoring:
1. External Ventricular Drain
2. Jugular bulb catheter
Hemoglobin < 100 g/L and decision has been made by Attending Physician to treat with one unit pRBC

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141674

Locations

Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Dean Chittock, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Dean Chittock )
Study ID Numbers:	C04-0459, VCHRI #V04-0261
Study First Received:	August 30, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00141674
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Blood transfusion
Age of blood
Traumatic Brain Injury
Cerebral Oxygen Extraction Ratio
Age of transfused blood in traumatic brain injury

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009