Navigation Links
Study of brain cooling and clot-busting drug therapy for stroke receives FDA OK to expand
Date:2/6/2013

LOS ANGELES (Feb. 5, 2013) An international multicenter clinical trial led by a Cedars-Sinai neurologist on the combination of brain cooling and "clot-busting" drug therapy after stroke has received Food and Drug Administration approval to expand from 50 patients to 400.

"This approval is highly significant because, after reviewing our initial safety data, the Food and Drug Administration approved us to include more patients in our study," said Patrick D. Lyden, MD, chair of the Department of Neurology at Cedars-Sinai Medical Center and the study's overall principal investigator. Thomas Hemmen, MD, PhD, director of the University of California, San Diego Health System Stroke Center, and James C. Grotta, MD, chair of the Department of Neurology at the University of Texas Health Science Center at Houston (UTHealth), are co-principal investigators.

This study, which includes the use of intravenous tissue plasminogen activator (IV tPA), the only FDA-approved treatment for acute stroke, is the latest in a series of clinical trials on brain cooling controlled hypothermia to reduce neurological damage after stroke.

Researchers employ a state-of-the-art system to provide rapid heat exchange and very fast cooling, achieved by inserting a special catheter into the inferior vena cava the body's largest vein. No fluid enters the patient; an internal circulation within the catheter absorbs the body's heat and transfers it out to slow metabolism, keep tissue swelling in check and give the brain time to rest.

Study participants are covered with a warming blanket to trick the body into feeling warm, and temperature sensors in the skin and a mild sedative help suppress shivering. Body temperature is cooled to 33 degrees Celsius (about 91 degrees Fahrenheit) for 24 hours before the patient is gradually warmed.

Brain cooling has been shown to decrease brain swelling and reduce loss of neurological function after acute stroke. It also has proved highly effective in saving lives and preventing neurological damage after heart attack and after oxygen deprivation in newborns.

TPA, which must be given to a patient as quickly as possible after stroke onset, sometimes can dissolve a clot and prevent or reduce serious brain injury. Lyden, the Carmen and Louis Warschaw Chair in Neurology at Cedars-Sinai, helped lead the pivotal clinical trial of the drug that led to its approval by the FDA in 1996.


'/>"/>

Contact: Sandy Van
sandy@prpacific.com
808-526-1708
Cedars-Sinai Medical Center
Source:Eurekalert

Related medicine news :

1. Shift to Hospice Care Often Comes Too Late, Study Finds
2. Steroid Shots for Tennis Elbow Miss the Mark: Study
3. Diabetes Drug May Offer Modest Weight Loss for Very Obese Teens: Study
4. Mammogram every 2 years has same benefit as yearly mammogram for older women, UCSF study finds
5. Sunshine Linked to Lower Rheumatoid Arthritis Risk: Study
6. Patient Involvement Lowers Health Costs, Study Says
7. UC San Diego funded by NIMH to study successful aging in adults with HIV
8. For Most Bullied Gay Kids, Things Do Get Better, Study Finds
9. New study finds water tubing-related injuries up 250 percent
10. No Evidence That Lupus Drugs Lead to Cancer, Says Study
11. Little House books Mary Ingalls probably did not go blind from scarlet fever, U-M study says
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... Information about the ... to develop to enable prevention of a major side effect of chemotherapy in ... in pediatric patients. For cisplatin, hearing loss is FDA listed on-label as a ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a ... of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners ... October 11, 2017. , The annual award competition recognizes editorial and design excellence across ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... (HLA), the nation's first interactive health literacy software tool, and the Cancer Patient ... aspects of cancer patient education, today announce a new strategic alliance. , ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vohra Chief ... advancements to physician colleagues, skilled nursing facility medical directors and other clinicians at ... of Wound Care." , "At many of these conferences we get to educate ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017  EpiVax, Inc., ... vaccine design, and immune-engineering today announced the launch ... the development of personalized therapeutic cancer vaccines. EpiVax ... provided exclusive access to enabling technologies to the ... MBA will lead EpiVax Oncology as Chief Executive ...
(Date:9/19/2017)... --  ZirMed Inc ., a recognized leader in cloud-based revenue ... been ranked #1 by its users for the seventh consecutive ... Survey. ZirMed was recognized as the top-ranked end-to-end revenue cycle ... over 200 beds and holds one of the longest #1 ... ...
(Date:9/12/2017)... , Sept. 12, 2017  Consumer reviews on the independent review ... as the number one company for hearing aids, ranking it higher ... other brands. ... Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides high performance, state-of-the-art, ...
Breaking Medicine Technology: