August 10, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a device (Prefilled Dual-Chamber Syringe; Pfizer, Inc) used to reconstitute and administer antihemophilic factor (recombinant) plasma/albumin-free intravenous infusion (Xyntha; Pfizer) in patients with hemophilia A.
The all-in-one syringe is the first to supply freeze-dried albumin-free recombinant factor VIII and also the diluent (0.9% sodium chloride), thereby eliminating the reconstitution transfer step and improving patient convenience.
"For the hemophilia A patient who is always on-the-go, any treatment option that can enhance convenience is critical to the management of his health and lifestyle," said Sue Geraghty, RN, MBA, nurse coordinator, University of Colorado School of Medicine Hemophilia and Thrombosis Center, Denver, in a company news release. "As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with hemophilia A convenience in reconstituting Xyntha, potentially saving them both time and effort."
The first ready-to-use syringe will be marketed in November 2010 and is designed to provide 3000 IU antihemophilic factor in a 4-mL volume. Lower doses are expected to be available in 2011.
Albumin-free recombinant factor VIII uses a next-generation purification process designed to address the potential risk for murine and other viral contamination. Previously available in single-use vials containing 250, 500, 1000, or 2000 IU freeze-dried powder, the product is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.
Saturday, August 21, 2010
Friday, August 20, 2010
Wednesday, August 18, 2010
International Symposium on Critical Bleeding 2010
International Symposium on Critical Bleeding 2010
September 6-7, 2010 Copenhagen Denmark
Main sessions:
Critical bleeding – overview of concepts
Coagulopathy of Critical Bleeding
Coagulopathy of Trauma - a new entity or an old tale?
Monitoring of haemostasis
Blood products and critical bleeding – what is the evidence?
Case discussions
Alternatives to Blood transfusion
Resuscitation strategies for massive haemorrhage – how I do it
Surgeons and critical bleeding – State of the Art
Antithrombotics and critical bleeding
September 6-7, 2010 Copenhagen Denmark
Main sessions:
Critical bleeding – overview of concepts
Coagulopathy of Critical Bleeding
Coagulopathy of Trauma - a new entity or an old tale?
Monitoring of haemostasis
Blood products and critical bleeding – what is the evidence?
Case discussions
Alternatives to Blood transfusion
Resuscitation strategies for massive haemorrhage – how I do it
Surgeons and critical bleeding – State of the Art
Antithrombotics and critical bleeding
Website HERE
Combat casualty care conference shows promising research returns
Top scientists gathered this week at an annual conference to discuss therapies for traumatic brain injuries and lifesaving medical tools to deploy to the battlefield. The annual Advanced Technology Applications for Combat Casualty Care Conference, which is being held this week in St. Pete Beach, Fla., includes presentations on topics ranging from regenerative medicine to pain control to more sensitive vital system monitors. But the two biggest issues talked about were traumatic brain injury and hemorrhage research, said Col. Dallas Hack, director of the Combat Casualty Care Research Program in the U.S. Army Medical and Materiel Command at Fort Detrick.
"We want to save the most lives we can, and that's hemorrhage," Hack said during a phone conference Tuesday morning.
Col. Lorne Blackbourne, commander of the U.S. Army Institute of Surgical Research in San Antonio, Texas, said his command presented a paper on Monday showing that half of the service members who died of injuries suffered "potentially survivable" wounds. Eighty percent of those were hemorrhages, Blackbourne said. Of those hemorrhages, 30 percent were in the legs and arms, where a tourniquet can be used to stop bleeding; 20 percent were in the neck, groin, armpit and areas where a tourniquet cannot be used but pressure can be applied to stop bleeding; and 50 percent were in the chest or abdomen, where pressure cannot stop the bleeding.
Blackbourne said combat medics are better trained than ever before and the tourniquet technique, in use for about 300 years, is "the most valuable piece of equipment" in the battlefield. He said the more certain way of saving lives is to find ways of bringing blood products to the field though.
In the civilian world, bleeding patients may be pumped with salt water or other clear liquids to keep their blood pressure up until they reach the hospital in a matter of minutes. In a combat zone, on the other hand, bad weather or enemy fire may keep a bleeding service member from being airlifted to a hospital for hours. Without plasma to promote clotting, or a blood transfusion, the patient can bleed to death before reaching the hospital.
Hack said two products showcased at the conference, which is sponsored by the Department of Defense, may be approved for use within a few years. Freeze-dried plasma is already in human trials, and spray-dried plasma is about six months behind, he said.
"We want to save the most lives we can, and that's hemorrhage," Hack said during a phone conference Tuesday morning.
Col. Lorne Blackbourne, commander of the U.S. Army Institute of Surgical Research in San Antonio, Texas, said his command presented a paper on Monday showing that half of the service members who died of injuries suffered "potentially survivable" wounds. Eighty percent of those were hemorrhages, Blackbourne said. Of those hemorrhages, 30 percent were in the legs and arms, where a tourniquet can be used to stop bleeding; 20 percent were in the neck, groin, armpit and areas where a tourniquet cannot be used but pressure can be applied to stop bleeding; and 50 percent were in the chest or abdomen, where pressure cannot stop the bleeding.
Blackbourne said combat medics are better trained than ever before and the tourniquet technique, in use for about 300 years, is "the most valuable piece of equipment" in the battlefield. He said the more certain way of saving lives is to find ways of bringing blood products to the field though.
In the civilian world, bleeding patients may be pumped with salt water or other clear liquids to keep their blood pressure up until they reach the hospital in a matter of minutes. In a combat zone, on the other hand, bad weather or enemy fire may keep a bleeding service member from being airlifted to a hospital for hours. Without plasma to promote clotting, or a blood transfusion, the patient can bleed to death before reaching the hospital.
Hack said two products showcased at the conference, which is sponsored by the Department of Defense, may be approved for use within a few years. Freeze-dried plasma is already in human trials, and spray-dried plasma is about six months behind, he said.
Tuesday, August 17, 2010
Call for Abstracts: 4th International Symposium on Women’s Health Issues in Thrombosis and Haemostasis
Call for Abstracts: 4th International Symposium on Women’s Health Issues in Thrombosis and Haemostasis
February 4-6, 2011 Berlin, Germany
Participants are requested to submit an abstract to the secretariat no later than October 5, 2010 together with the registration form and fees. Authors will be notified regarding abstract acceptance. Accepted abstracts will be presented during a poster session. Abstracts selected by the Scientific Committee will be presented as short Oral Communications during the symposia. All accepted abstracts will be printed in the Book of Abstracts that will be distributed at the Symposium.
Secretariat and Symposium Organizers
Palex Tours Ltd. Israel
59 Ha'atzmaut Road, PO Box 33018, Haifa 33033, Israel
Tel: +972 - 4666 - 0510/11; Fax: +972 - 4852 - 2491
E-mail: whith2011@palex.co.il
Website: www.palexconventions.co.il/whith2011
February 4-6, 2011 Berlin, Germany
Participants are requested to submit an abstract to the secretariat no later than October 5, 2010 together with the registration form and fees. Authors will be notified regarding abstract acceptance. Accepted abstracts will be presented during a poster session. Abstracts selected by the Scientific Committee will be presented as short Oral Communications during the symposia. All accepted abstracts will be printed in the Book of Abstracts that will be distributed at the Symposium.
Secretariat and Symposium Organizers
Palex Tours Ltd. Israel
59 Ha'atzmaut Road, PO Box 33018, Haifa 33033, Israel
Tel: +972 - 4666 - 0510/11; Fax: +972 - 4852 - 2491
E-mail: whith2011@palex.co.il
Website: www.palexconventions.co.il/whith2011
Cutting back on blood use could halt infections, illness — and even death
SEATTLE — As a doctor and a patient, Dale Reisner knows the value of donated blood. But when the Seattle obstetrician had to have heart surgery four years ago, she did everything possible not to get a single drop.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.
“I don’t have any religious problems with it. If I was near death, I definitely would have taken blood, no question,” said Reisner, who is fine now at age 62. “But if I could avoid a transfusion by better pre-op preparation, then I was interested.”
Dr. Dale Reisner actively avoided a blood transfusion during surgery to repair a mitral valve in her heart.
Long dominated by Jehovah’s Witnesses — whose faith forbids blood transfusions — bloodless surgeries and blood conservation programs are now attracting mainstream patients worried about what some experts say are clear risks, including more infections, longer recuperation, increased illness and even death.
"The best blood is in your own veins,” said Dr. Lori Heller, medical director of the blood management program at Swedish Medical Center in Seattle, where Reisner had her surgery — without any transfusion. “We want to think before we transfuse.”
Decades of experience with Jehovah’s Witness patients, including 1.5 million members in the United States, has helped propel the new emphasis on blood management, said Sherri Ozawa, clinical director of the Institute for Patient Blood Management at Englewood Hospital and Medical Center in New Jersey.
“In the early days, it was, ‘We have Witness patients, what in the world do we do with them?’” she recalled. “Now we believe it should be the standard of care.”
More doctors, from cardiac surgeons to orthopedists, are offering patients ways to conserve their own blood and avoid transfusions. From drugs that boost blood levels before surgery to cell salvage and blood diversion techniques during operations and lower thresholds for giving blood at all, the techniques are a sea change in the attitude that more blood is always better.
Saturday, August 14, 2010
Interesting Thrombin Paper
Clinical use of Topical Thrombin as a Surgical Hemostat. Click to Enlarge - includes commentary on Oxidised Cellulose, Collagen and Gelfoam.
Wednesday, August 11, 2010
Egypt - Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission
The Arab Republic of Egypt has the highest rates of new hepatitis C virus (HCV) infection in the world, according to a new study published today in the prestigious Proceedings of the National Academy of Sciences. The study also estimates more than 500,000 new HCV infections occur in Egypt every year, likely signaling an epidemic in a country of more than 77 million people. This high rate of HCV transmission may be due to the lack of sufficient standard safety precautions in medical and dental facilities, the authors suggest. “Nearly 7 out of every 1,000 Egyptians acquire HCV infections every year, suggesting intense ongoing transmission. This is the highest level of HCV transmission ever recorded at a national level for a blood borne infectious disease transmitted parenterally, that is, by use of non-sterile medical instruments,” said Dr. F. DeWolfe Miller, lead author of this study and professor of epidemiology at the Department of Tropical Medicine and Medical Microbiology and Pharmacology at the University of Hawaii.Although the high prevalence of hepatitis C in Egypt has been well established for many years, and linked in part to limited safety measures during anti-bilharzia campaigns, published estimates of prevalence from different Egyptian communities failed to provide a nationwide picture of the magnitude of ongoing HCV infection transmission.
To estimate the rate of new HCV cases of infection in Egypt, the authors of the study performed epidemiologic modeling of data from a range of studies, including a 2008 national HCV survey with a representative sample and well-documented study design.“The study opened our eyes to a disease burden similar in scale and challenge to the HIV problem in sub-Saharan Africa: Millions of cases of an infection for which there is no vaccine, no effective treatment, and where case management is so expensive that it is beyond the reach of most patients,” said Dr. Laith J. Abu-Raddad, co-author of the study and assistant professor of public health at the Infectious Disease Epidemiology Group at the Weill Cornell Medical College–Qatar.
The study necessitates not only further analysis of HCV transmission in Egypt but also justifies the immediate increase of resources to strengthen public health measures aimed at reducing the transmission of HCV in clinical and non-clinical settings, according to the authors. Failure to address this problem will result in a massive disease burden in the nation in terms of HCV infection complications, including active liver disease, liver failure, or liver cancer.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.
“There is only one way to deal with the HCV challenge in this country: HCV prevention,” warned Dr. Miller. “Effective and stronger HCV prevention programs are urgently needed in Egypt. Failure to act could swamp the public health system over the coming decades with millions of cases of HCV disease complications with an economic and social cost that this nation does not have the means to confront.”
Key scientific findings of the study
• Nearly 7 out of each 1,000 Egyptians acquire HCV infection every year for a total of 537,000 new HCV infections every year. This is by far the largest ever recorded rate of occurrence of HCV at a national level of all countries in the world.
• One in every 10 Egyptians is a carrier of the HCV infection, which means that there are at least 4,459,000 persons infected with HCV who are infectious to others. This is the largest reservoir of HCV infection in the world.
• Contrary to the widely-held perception that this rate of occurrence reflects merely the limited safety measures during anti-bilharzia campaigns, HCV incidence likely continues at alarming levels due to limitations in the implementation and enforcement of stringent standard precautions in public and private medical and dental facilities.
FDA APPROVES 8 MG VIAL OF NOVOSEVEN®
Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) in an 8 mg vial size, making the hemophilia A or B with inhibitors treatment available in 1, 2, 5 and 8 mg vials. The 8 mg vial allows a rapid initiation and administration of this medication for those patients who need a larger dose. In addition, FDA has also approved the extension of shelf life for all vial sizes from 24 months to 36 months at room temperature (at or below 77 degrees Fahrenheit).
NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.
"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.
For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution - the time it takes to prepare the injection - than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.
"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well - fewer vials may mean less waste."
The new vial size is expected to be available by November.
NovoSeven® RT is specially formulated to treat people with hemophilia A or B with inhibitors. Hemophilia, which is typically diagnosed in childhood, is a chronic, inherited bleeding disorder that occurs when certain blood clotting factors are missing or do not work properly, resulting in easy bruising and prolonged bleeding from trauma. Spontaneous internal bleeding can occur as well, particularly in the joints and muscles. Inhibitors, a serious complication that can occur after treatment, develop in as many as 30 percent of those with hemophilia. In these cases, antibodies form that neutralize or attack the blood coagulation agents contained in the treatment, resulting in joint disease and making it more difficult to manage bleeds.
"When I get a bleed, I want to infuse my treatment right away. The faster I treat a bleed, the sooner I can continue with my daily routine," said Bob Hoyt, a member of the Novo Nordisk Changing Possibilities Coalition. "Using fewer vials will be a positive change for patients." Hoyt has been living with hemophilia with inhibitors most of his life.
For many people living with hemophilia with inhibitors, the 8 mg vial will allow for faster reconstitution - the time it takes to prepare the injection - than their current NovoSeven® RT regimen. Those who previously had to use three vials to deliver an 8 mg dose will now have to reconstitute only one vial. Though the amount of powder in the 8 mg vial is larger than the 5 mg vial, the vial will be the same size and will have a yellow cap to distinguish it from the smaller dose.
"We have heard from patients and physicians alike that when they are treating a bleed, every second counts. We at Novo Nordisk are committed to improving the lives of people living with hemophilia with inhibitors," said Eddie Williams, Vice President, Biopharmaceuticals, at Novo Nordisk. "The NovoSeven® RT 8 mg vial will allow patients to get the medicine they need much faster when experiencing a bleed, without having to manage multiple vials. We're also pleased that it will have a positive environmental impact as well - fewer vials may mean less waste."
The new vial size is expected to be available by November.
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