(SAFE TBI II)
Fluid resuscitation for patients with traumatic brain injury - potential mechanisms behind the detrimental effect of albumin resuscitation (SAFE TBI II)
Chief Investigator: Professor Jamie Cooper
Other Investigators: Associate Professor John Myburgh, Associate Professor Simon Finfer, Professor Rinaldo Bellomo, Professor Robyn Norton
Lead Organisation: Bayside Health
TAC Neurotrauma Funding: $227,700
Project Dates: 15 June 2007 – 15 February 2010
All patients with traumatic brain injury (TBI) are treated with intravenous fluids that help maintain an adequate blood pressure so that vital organs such as the brain are perfused. The landmark SAFE study (the largest randomised controlled trial ever to be conducted within Intensive Care Units) suggested that, at the 28 day mark, patients that were receiving an albumin-based fluid for resuscitation were more likely to die from their injuries, than those who received saline fluid resuscitation. This finding was confirmed in the TAC funded study SAFE-TBI that was published in the New England Journal of Medicine (August 2007).
The SAFE TBI II study was conducted to search for mechanisms behind the differences in mortality between albumin and saline resuscitation in those patients with TBI.
SAFE TBI II went back and looked at the medical charts of the 460 study patients from SAFE–TBI . The study period was defined as the first 14 days after randomisation, as this was the time period when most deaths occurred.
In each patient the case history, ICU charts, pathology results and radiology test results were examined and the key values and therapeutic interventions were recorded. These included: type and duration of ICP monitoring, intracranial pressures, the medications infused to control and treat intracranial hypertension, the drugs and therapies used to achieve vascular and intracranial pressure treatment goals, and measures of coagulation status, blood electrolytes and blood gases.
Mean daily measurements were done of ICP, volume of CSF drained through ventricular drainage catheters, blood gas results, daily doses of drugs to control ICP, drugs used to support blood pressure, and measures of coagulation status.
Results of CT brain scans were scored using the Marshall classification by an independent blinded trauma neuroradiologist. These scans were compared and assessed for progression or regression of brain swelling.
The results of the study suggest a likely mechanism for the increased mortality in those patients with TBI and are likely to lead to recommendations for clinical practice.
The details of the results are currently embargoed for public dissemination since they are being submitted for publication in international medical journals as a follow-up to the previous study.
MYBURGH J, COOPER DJ, FINFER S, BELLOMO R, NORTON R, BISHOP N, LO S-K, VALLANCE S. Resuscitation with saline compared to albumin in traumatic brain injury. New England. J Med. 2007;357:874-84.
COOPER DJ. Outcomes from severe traumatic brain injury can be improved Society of Critical Care Medicine 37th Annual Congress; 2008 February 2-6, Hawaii, USA.
COOPER DJ. Traumatic Brain Injury - Where are we today? Trauma Melbourne; 2008 November 20-22, Melbourne, Australia.
COOPER DJ Albumin resuscitation in traumatic brain injury. Critical Care Canada Forum; 2009 October 25-28, Toronto, Canada.
COOPER DJ. Critical Care Networks experience - The Australian Experience. First Neurocritical Care Research Conference; 2009 September 6, Texas, USA.
COOPER DJ. TBI Outcomes - More optimism. Critical Care Canada Forum; 2009 October 25-28, Toronto, Canada.
COOPER DJ How I manage Traumatic Brain Injury. Saudi Critical Care Society Annual Scientific Meeting; 2010 April 27-29, Jeddah, Saudi Arabia.
COOPER DJ. Albumin for Traumatic Brain Injury Resuscitation. Saudi Critical Care Society Annual Scientific Meeting; 2010 April 27-29, Jeddah, Saudi Arabia.