The Society for the Advancement of Blood Management (www.SABM.org) is a non-profit organization with several mandates dedicated to improving blood management based on evidence-based medicine. One basic premise is that proper blood management will include alternatives to allogeneic blood products.
The Society for the Advancement of Blood Management is a co-sponsor of meetings known as STORMACT (Strategies TO Reduce Military And Civilian Transfusions). There have been five meetings of STORMACT since October of 2001 held at the behest of US military medical leaders seeking optimal resuscitation management strategies, including those of immediate concern on the battlefield. This document is a summary of a working draft to be published later this year by physicians concerned with fluid management and resuscitation.
Because the current concern relates to cardiac surgery with cardiopulmonary bypass, our clinical experience with over 400 patients having cardiopulmonary bypass during cardiac surgery is relevant. We employ aggressive colloid therapies using hydroxyethyl starches (Hextend exclusively). We measure thromboelastography at baseline after anesthesia is begun, before and after hemodilution, and at the end of bypass. We are beginning to present these data, but at present we can say with certainty that no clinically significant bleeding has been observed. Furthermore, our rate of transfusion is 11% perioperatively for cardiac surgery.
The STORMACT findings are a consensus of opinions on the relative effectiveness of fluid resuscitation. We have reached a consensus that the carrier of the hydroxyethyl starches, is the culprit of any coagulation abnormality and only then under specific circumstances. High chloride concentration and the absence of calcium may be the reason for additional bleeding with hydroxyl starch in saline. Hydroxyl starch in balanced salt solution have enabled clinicians familiar with this agent, to infuse large doses without increased risk of bleeding.
On balance, we urge the FDA to take a cautionary approach to any restrictive measures. As major proponents of the efficacy of Hextend in particular we believe data support conclusions that blood management and the avoidance of transfusions are supported by the use of Hextend.
The members of STORMACT are as follows:
1) Healtherlee Bailey, MD, FAAEM, Assistant Professor of Emergency Medicine,
Associate Program Director for the Department of Emergency Medicine
MCP Hospital
3300 Henry Avenue Philadelphia, PA19129
2) Daniel Freilich, CDR, MC, USNR, Director Hematomimetics Program
Naval Medical Research Center Combat Casualty Resuscitation
Directorate
503 Grant Avenue Silver Spring, MD 29010-7500
3) Lawrence Tim Goodnough, MD, Professor of Medicine and Pathology & Immunology, Division of Laboratory Medicine
Washington University in St. Louis School of Medicine
660 S. Euclid Avenue St. Louis, MO 63110
4) Lewis Kaplan, MD, FACS, Associate Professor and Director of Surgical Intensive
Care Unit
MCP Hospital
3300 Henry Avenue Philadelphia, PA 19129
5) Richard Spence, MD, FACS, Director of Surgical Education, President of the
Society for the Advancement of Blood Management (SABM)
Birmingham Baptist Health Systems
701 Princeton Avenue SW 4 East Birmingham, AL 35211-1399
6) Aryeh Shander, MD, Chief Department of Anesthesiology, Critical Care
Medicine, Pain Management and Hyperbaric Medicine, Medical Director of
the New Jersey Institute for the Advancement of Bloodless Medicine and
Surgery, Executive Director of the Society for the Advancement of Blood
Management (SABM)
Englewood Hospital and Medical Center 350 Engle Street Englewood, NJ
07631
7) James Wright, MD, Col, Chief of Clinical Investigations Branch
Davis Hyperbaric Laboratory
USAFSAM/FEH 2602 W. Gate Road Brooks AFB TX 78235-5252
For the Society for the Advancement of Blood Management, and representing the consensus opinion of STORMACT, I submit this as,
Yours truly,
Aryeh Shander, MD, FCCM, FCCP
Executive Director
Society for the Advancement of Blood Management