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:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... nation's first interactive health literacy software tool, and the Cancer Patient Education Network ... cancer patient education, today announce a new strategic alliance. , As CPEN’s ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an update ... Puerto Rico , where the company manufactures ... Following a comprehensive onsite assessment, the ... temporary loss of power and minimal water damage due ... have resumed, and the company expects to return to ...
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/2/2017)... 2017 Diplomat Pharmacy, Inc. (NYSE: ... Consulting, LLC , and named its founder as Diplomat,s ... Tennessee , will operate under Diplomat ... service offerings for health care partners to include IT ... "In an interoperable world, technology delivers comprehensive ...
Breaking Medicine Technology: