Tuesday, September 18, 2012

EMMC program to reduce blood transfusions draws international interest


BANGOR, Maine — Eastern Maine Medical Center is hosting physicians and researchers from abroad this month who are interested in the hospital’s work to reduce unnecessary blood transfusions.
On Monday, a team from western Australia visited Bangor for a hands-on introduction to EMMC’s “patient blood management program,” which began in 2007 as an effort to cut down on avoidable blood transfusions. On Sept. 24, a team from Switzerland will visit the hospital to learn about the program.
EMMC has reduced the number of blood transfusions it performs by 60 percent since 2006, according to Dr. Irwin Gross, medical director of transfusion services at the hospital.
In some cases, transfusions can save lives, such as by replenishing the blood lost by severely injured trauma patients, he said. But transfusions aren’t always necessary for some conditions and can lead to complications.
The risks associated with blood transfusions have traditionally centered on patients’ exposure to diseases, such as hepatitis and HIV, Gross said. In recent years, however, with the blood supply widely considered safe, the concerns have shifted to research indicating that transfusions are associated with longer hospital stays and greater risk of hospital-acquired infections and other complications, he said.
EMMC has cut down on unneeded transfusions by screening patients for anemia before they arrive for procedures such as hip and knee replacements, Gross said. By treating the condition — a lack of healthy red blood cells in the body — ahead of time, surgeons often can avoid the need for a transfusion.
“Once [patients] are here, we use medications and surgical techniques to try to minimize the amount of blood that’s lost,” he said.
While orthopedic procedures such as joint replacements often involve blood transfusions, the procedure is actually more common in nonsurgical hospital admissions, particularly among cancer patients, Gross said.
The hospital also has integrated the blood management strategies into its electronic medical records system, which helps doctors to make better decisions about when transfusions are necessary while reviewing patients’ histories, Gross said.
The team from western Australia, which is visiting EMMC through Wednesday, is interested in developing a blood management program across a number of hospitals in their region, he said. The group from the University Hospital Zurich, visiting next Monday, plans to do the same within their hospital, Gross said.

Childhood Coagulation Marker Levels Distinct From Adulthood

Levels of key coagulation markers significantly vary with age in children, research reveals, potentially affecting the diagnosis and treatment of pediatric thrombotic and hemorrhagic disease.

Young children have significantly lower levels of fibrinogen and factor (F)II, IX, XI, and XII than older children, the researchers report in the Journal of Thrombosis and Haemostasis.

Younger age was also associated with significantly lower levels of Protein C and Protein S, but higher concentrations of D-dimer.

Von Willebrand factor (vWF) levels were also elevated in the first year of life, but there was no associated increase in FVIII levels, expected due to the known impact of vWF on FVIII half life.

vWF levels fell to a nadir at 1 year and then gradually increased to adult levels, but this trend was dependent on blood group type. Blood group O carriers showed only a slight increase from a median of 66% to 88% of adult levels, versus a median 106% in non-O blood group carriers.

The researchers believe this may be due to the increased susceptibility of vWF of blood group O to the proteolytic activity ofADAMTS13 compared with non-O blood groups. In the first months of childhood, when A, B, and H antigens of vWF are low, there may be less pronounced blood group differences in vWF levels.

"Our results underline the need for age-specific reference ranges," write Inge Appel and co-workers, from Erasmus Medical Centre - Sophia Children's Hospital in Rotterdam, the Netherlands.

The greatest variation was between infants in the first year of life versus adults, but inter-individual variability in coagulation factors was highest in the youngest children. The researchers therefore recommend: "In neonates and infants multiple reference samples are required to define the normal range in coagulation proteins for age more precisely."

The team examined blood samples from 218 healthy children aged 1-6 months (n=29), 7-12 months (n=25), 1-5 years (n=57), 6-10 years (n=57), 11-18 years (n=50), and over 19 years (n=52) using two different analyzers; the Behring Coagulation System (Siemens Healthcare Diagnostics Products GmbH, Marburg, Germany) and the CA-1500 system (Sysmex, Kobe, Japan).

There was good correlation between the two systems for all coagulation markers, except prothrombin and activated partial thromboplastin time.

Alok Khorana To Head ISTH Subcommittee


Pittsford N.Y. resident Alok Khorana, M.D., vice chief of the Hematology/Oncology division at the James P. Wilmot Cancer Center, has been appointed chairman of the Hemostasis and Malignancy Subcommittee of the International Society of Thrombosis and Haemostasis (ISTH). 
The appointment signifies Khorana’s growing reputation as a global authority on thrombosis and other blood disorders.
In his new leadership role, Khorana will be responsible for the Subcommittee's 2013 program of work, primarily the 2013 Scientific Subcommittee Meeting, which will take place in conjunction with the 24th ISTH Congress in June in Amsterdam. Khorana is tasked with proposing educational topics and speakers for the session.
Khorana, who is also an associate professor of Hematology/Oncology in the Department of Medicine, has been at the Cancer Center since coming to the University of Rochester Medical Center as a fellow in Hematology/Oncology in 1999.

Tuesday, September 4, 2012

Baxter Submits Application for FDA Approval of Recombinant Factor IX for the Treatment of Hemophilia B


DEERFIELD, Ill. - Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a biologics license application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for approval of BAX 326, a recombinant factor IX (rFIX) protein being investigated for the treatment and prophylaxis of bleeding episodes for patients over 12 years of age with hemophilia B.
Hemophilia B, also known as Christmas disease, is the second most common type of hemophilia and results from insufficient amounts of clotting factor IX, a naturally occurring protein in blood that helps to control bleeding. 1 Approximately 25,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. 2
The BLA filing is based on results from a global Phase III study conducted in 10 countries around the world. The prospective, controlled, multicenter study evaluated the pharmacokinetics, efficacy, safety and immunogenicity of BAX 326 in 73 patients with severe or moderately severe hemophilia B previously treated with other factor IX therapy. The study met its primary objectives and the company plans to present the complete data from the study in late 2012. Baxter expects to file its application for BAX 326 in Europe in 2013.
"Hemophilia B patients have relatively limited options for their treatment today, with only one commercially available recombinant (genetically engineered) protein. As part of our long-standing commitment to the hemophilia community, we continue to pursue new potential treatment options like BAX 326 to support patients with this debilitating disease," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business.
In select countries, Baxter currently offers a plasma-derived factor IX treatment, Immunine [Factor IX Concentrate (Human)], for patients with hemophilia B, which has more than 16 years of patient experience in Europe and Latin America. In addition, Baxter recently announced a partnership with Chatham Therapeutics, LLC to develop a gene therapy based treatment for hemophilia B. Gene therapy could represent another important first for the community as an innovative potential therapy for hemophilia B treatment.