Navigation Links
Study of brain cooling and clot-busting drug therapy for stroke receives FDA OK to expand

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
Cedars-Sinai Medical Center

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:
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its ... Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding ... Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, we ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Surgical Procedure Volumes: Global Analysis (United States, ... Australia, Canada)" report to their offering. ... an essential tool for healthcare business planners, provides surgical ... looks at surgery trends with an in-depth analysis of ...
(Date:6/23/2016)... 2016 The Biotechnology industry might ... present great opportunities to investors. assesses the recent ... (NYSE: XON ), Vertex Pharmaceuticals Inc. (NASDAQ: ... ARNA ), and Regeneron Pharmaceuticals Inc. (NASDAQ: ... receive your complimentary trade alerts at: ...
(Date:6/23/2016)... , June 23, 2016 Leading BioSciences ... address medical conditions resulting from a breakdown of ... appointed Greg Doyle as chief executive ... BioSciences, executive management team and board of directors, ... financial officer. He will provide continued leadership and ...
Breaking Medicine Technology: