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Related terms: Coagulopathy, Consumption coagulopathy, Disseminated Intravascular Coagulation (DIC), DIC

Tretten Approved for Genetic Clotting Disorder

Posted 23 Dec 2013 by Drugs.com

MONDAY, Dec. 23, 2013 – Tretten (coagulation factor XIII A-Subunit recombinant) has been approved by the U.S. Food and Drug Administration to treat a very rare blood clotting disorder called congenital Factor XIII A-Subunit deficiency. People with the genetic disorder do not make enough Factor XIII, a blood component that promotes clotting. Tretten, a human recombinant produced in yeast cells, makes up for this deficiency, which could otherwise be life threatening, the FDA said Monday in a news release. Tretten was evaluated in a clinical study of 77 people with the disorder. Administered monthly, it was effective in preventing bleeding in 90 percent of recipients. Side effects included headache, extremity pain and pain at the injection site. No study participant developed abnormal clotting, the FDA said. The product was developed and is produced by Novo Nordisk, based in Denmark. More ... Read more

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Later Clamping of Umbilical Cord May Benefit Newborns: Study

Posted 11 Jul 2013 by Drugs.com

THURSDAY, July 11 – Doctors may be clamping umbilical cords too soon after a baby's birth, according to a new study. Doctors routinely clamp and sever the umbilical cord less than a minute after birth, a practice believed to lower the risk of severe bleeding in the mother. But this new study found that delaying clamping for at least a minute after birth allows more time for blood to move from the placenta and helps boost iron stores and hemoglobin levels in newborns, without increasing the risks to mothers, The New York Times reported Thursday. Compared with babies who had early clamping, those who had delayed clamping had higher hemoglobin levels 24 to 48 hours after birth and were less likely to be iron deficient three to six months after birth, the Times reported. Later clamping did not increase the mothers' risk of severe bleeding after birth, blood loss or reduced hemoglobin ... Read more

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FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding

Posted 6 May 2013 by Drugs.com

April 29, 2013 – The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma. “The FDA’s approval of this new product gives physicians a choice when deciding h ... Read more

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Major Bleeds After Heart Procedures May Raise Death Risk: Study

Posted 12 Mar 2013 by Drugs.com

TUESDAY, March 11 – Patients with major bleeding after procedures to open blocked heart arteries are at significantly increased risk for death, according to a new study. Researchers analyzed data from 3.3 million percutaneous coronary interventions (balloon angioplasty and stent-placement procedures) performed in the United States between 2004 and 2011. The study found that 1.7 percent of the patients had major bleeding after their procedure and 0.65 percent of them died in the hospital. The in-hospital death rate for patients with major bleeding was 5.3 percent, compared with 1.9 percent for those without bleeding. After taking other factors into account, the researchers calculated that patients with major bleeding after percutaneous coronary intervention had about a 12 percent increased risk of in-hospital death, according to the study, which was published in the March 13 issue of ... Read more

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Fraudulent Data May Have Led to Use of Risky Treatment in ICUs

Posted 19 Feb 2013 by Drugs.com

TUESDAY, Feb. 19 – Studies loaded with fraudulent data may have encouraged the use of a treatment for patients in intensive care units that now appears to do more harm than good, new research shows. At issue is hydroxyethyl starch, an intravenous solution sometimes used to replace lost blood volume in critically ill patients. According to a new review article in the Feb. 20 issue of the Journal of the American Medical Association, the starchy solution may instead boost their risk of death or kidney failure. "Almost certainly, what is happening is that some of the starch molecules leak out of blood vessels into the kidney itself so the kidney doesn't work as efficiently," said Dr. David Taylor, chairman of pulmonary and critical care medicine at Ochsner Health System in New Orleans. He was not involved in the new review. Luckily for American patients, hydroxyethyl starch is not commonly ... Read more

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Octaplas Approved for Blood-Clotting Disorders

Posted 17 Jan 2013 by Drugs.com

THURSDAY, Jan. 17 – Octaplas has been approved by the U.S. Food and Drug Administration to augment insufficient clotting proteins that could otherwise lead to excessive bleeding or excessive clotting. The product is a sterile, frozen solution made from human plasma. A "solvent detergent process" is applied to minimize the possibility of serious viral transmission, the agency said. Octaplas should be matched to the recipient's blood type to help avoid transfusion reactions. Each lot is measured for the required presence of clotting factors before the lot is approved for use, the FDA said. The current version has been used in Europe and elsewhere since 2006, and a prior formulation was first used in 1992. In all, more than 2 million people have been treated with more than 7 million doses outside the United States, the agency said. Clinical testing of Octaplas focused on people with liver ... Read more

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Health Tip: What's Behind Your Nosebleed

Posted 21 Dec 2012 by Drugs.com

-- Nosebleeds affect one in seven people during their lives, the American Academy of Otolaryngology says. They're most common among people aged 2-10, and aged 50-80. The academy says the most common causes of nosebleeds include: Dryness, allergies or infections. Blowing your nose too hard. A blood clotting problem triggered by heredity or a current medication. A skull fracture or fracture of the nose. Tumors or hereditary blood vessel disorders. Read more

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FDA Approves Corifact to Prevent Bleeding in People With Rare Genetic Defect

Posted 21 Feb 2011 by Drugs.com

SILVER SPRING, Md., Feb. 17, 2011 /PRNewswire-USNewswire/ – The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency. Patients with congenital Factor XIII deficiency don't make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding. Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding. "This product helps fill an important need," said Karen Midthun, M.D., director of the FDA's Center for Biologics ... Read more

Related support groups: Bleeding Disorder, Bleeding Associated with Coagulation Defect

Gene Therapy Corrected Rare Bleeding Disorder: Study

Posted 6 Dec 2010 by Drugs.com

SUNDAY, Dec. 5 – Using gene therapy, German researchers report that they managed to "correct" a malfunctioning gene responsible for Wiskott-Aldrich syndrome, a rare but devastating childhood disorder that leads to prolonged bleeding from even minor hits or scrapes, and also leaves these children vulnerable to certain cancers and dangerous infections. However, one of the 10 kids in the study developed acute T-cell leukemia, apparently as a result of the viral vector that was used to insert the healthy gene. The boy is currently on chemotherapy, the study authors noted. "This is a very good first step, but it's a little scary and we need to move to safer vectors," said Dr. Mary Ellen Conley, director of the Program in Genetic Immunodeficiencies at St. Jude Children's Research Hospital in Memphis, Tenn. "The study shows proof-of-principle that gene therapy with stem cells in a genetic ... Read more

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