Blood Transfusion and Outcomes

International panel of experts finds little evidence for transfusions
improving health

MILWAUKEE, Wis., April 22 /PRNewswire/ -- An exhaustive review and analysis of
the medical literature by a panel of experts at the International Consensus
Conference on Transfusion and Outcomes (ICCTO) held this month in Phoenix
concluded that there is little evidence to support a beneficial effect from
the greatest number of transfusions currently being given to patients. The
vast majority of studies show an association between red blood cell
transfusions and higher rates of complications such as heart attack, stroke,
lung injury, infection and kidney failure and death.

The ICCTO conference brought together leading international physicians and
scientists in the fields of anesthesiology, intensive care, hematology,
oncology, surgery, and patient blood management, and was monitored by the Food
and Drug Administration, the American and the Australian Red Cross, the Joint
Commission, along with government health officials, and other organizations.

"The results of the conference firmly establish the view that, rather than
being a benign procedure, blood transfusion is associated with increased risk
of medical complications," said Aryeh Shander, M.D., Chief of the Department
of Anesthesiology, Critical Care Medicine, Pain Management and Hyperbaric
Medicine at Englewood Hospital and Medical Center in Englewood, NJ and a
founding member of the Society for the Advancement of Blood Management (SABM).
"The evidence tells us to restrict the practice of transfusion and to avoid
unnecessarily transplanting stored blood that could harm a patient's
recovery."

About ICCTO:
Safety concerns with blood initially came to the public's awareness with the
realization that infectious agents such as HIV could be transmitted via blood
transfusion. Careful screening and testing have resulted in the risk of known
infectious agents being transmitted via blood being reduced to extremely low
levels. Since then, concern has emerged amongst many in the medical profession
that transfusion itself may be a risk factor for adverse patient outcomes. It
has been known for some time that blood undergoes many physical and chemical
changes during storage, losing its ability to supply oxygen to vital organs
and triggering inflammatory and immune reactions when transfused. It is now
thought by some that these storage-related problems may result in negative
outcomes to patients.

ICCTO was convened by two professional medical societies, the USA based
Society for the Advancement of Blood Management (SABM) and the international
Medical Society for Blood Management (MSBM), out of concern for the lack of
evidence supporting transfusion effectiveness and the growing number of
studies reporting the association between transfusion and negative patient
outcomes. Because blood transfusion came into medical use decades ago, it has
never been subject to the same rigorous safety and efficacy assessment process
applied today to other drugs and treatments before they are approved for use.
This has resulted in a great deal of uncertainty and lack of knowledge among
physicians as to whether a patient should or should not be transfused. As a
consequence, there is enormous variation in transfusion practice between
countries, states within countries, hospitals and even between clinicians
within the same institution.

The accepted "consensus conference" process using the RAND-UCLA method was
chosen to unravel some of this uncertainty. This method involves a
comprehensive review of all published scientific studies on a treatment, after
which a panel of experts assesses a series of patient scenarios using the
scientific literature to determine whether the treatment has evidence to
support that it will improve the patient's outcome.

The ICCTO panelists also considered what has come to be known as the Bradford
Hill Criteria for establishing causation, the process Sir Austin Bradford Hill
and Sir Richard Doll used in the 1960s to establish that cigarette smoking
caused such diseases as lung cancer and emphysema.

The ICCTO literature review searched for all studies on blood transfusion and
outcomes published in the last 13 years. 555 studies met study inclusion
criteria and were analyzed by each panelist in preparation for the conference.

A great majority of these studies were initiated to investigate the benefits
of transfusions, and instead either found no benefit or identified negative
outcomes associated with blood transfusions. Only a small minority of clinical
scenarios, were associated with suggested improved outcome.

The panel confined this initial ICCTO analysis to stable non-bleeding
patients. Approximately sixty percent of the 90 million units collected around
the globe each year (14 million units annually in the USA) are given to such
patients.

"Given what we now know, donor transfusions should be limited only to surgery
patients who are experiencing major bleeding that is difficult to control
quickly," said James Isbister, MD, Clinical Professor of Medicine at the
University of Sydney, and a founding member of MSBM. "We hope the conference
will help all physicians and the public become aware of the many negative
outcomes associated with transfusion, and call for blood management strategies
to improve patient outcomes."

The two convening societies
SABM and MSBM are educational organizations comprised of a network of
practitioners from a wide variety of medical and scientific disciplines who
are dedicated to improving patient outcomes and the advancement of optimal
patient blood management in clinical practice through education, cooperation
and research. The societies work to facilitate cooperation among existing and
future patient blood management/blood conservation, (and/or) bloodless
medicine and surgery programs as well as enhance the clinical and scientific
aspects of transfusion practice. Patient blood management seeks to optimize
and conserve the patient's own blood, reducing or avoiding the need for a
blood transfusion. Stored donor blood should only be used as therapy, with
patient consent, when there are no alternatives, and when the expected
benefits exceed the negative consequences. Additional information is available
at www.sabm.org and www.bloodmanagement.org

SOURCE Society for the Advancement of Blood Management

Dave Schemelia, +1-646-722-8819