Age of Blood in Brain Injury

NCT00141674 | Completed

• 2 other identifiers: C04-0459VCHRI #V04-0261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  24 hours

Interventions

Blood Transfusion PROCEDURE

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Dean Chittock, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 4, 2008

Record last verified: 2008-09

Locations

CA (1)