Navigation Links
Henry Ford Hospital: Unique Patient Study -- No Informed Consent
Date:5/8/2009

DETROIT, May 8 /PRNewswire/ -- Henry Ford Hospital is embarking on an unusual study intending to reduce brain damage or death of patients resulting from prolonged seizures before arriving at the hospital.

But because the patients are unconscious during the seizure, they will not be able to provide informed consent to participate in the study.

The Food and Drug Administration created regulations for research to be performed during emergency conditions without informed consent of the participant. Once patients awaken from the seizure their consent will be sought to continue in the study.

The study will involve patients with seizures lasting longer than five minutes that are being transported by EMS. Stopping the seizure as soon as possible is important to prevent brain-damage or death. Often the underlying cause of the seizure is unknown, but some causes include previous trauma, stroke, tumor, or infection.

The study, called RAMPART, will compare an intramuscular injection of midazolam (Versed) to an intravenous (IV) dose of lorazepam (Ativan). Both drugs are better than the most common current prehospital treatment for seizure, IV diazepam (Valium). The goal is to determine if an auto-injector with midazolam can stop seizures as fast as starting an IV and giving lorazepam.

The benefits include shorter seizures, more rapid drug administration, development of an auto-injector that could be used by non-medical personnel, and avoidance of multiple IV attempts on a seizing patient.

The three-year RAMPART study is being conducted at 17 centers around the United States. It is coordinated by the University of Michigan and funded by the National Institute of Neurological Diseases and Stroke which is a part of the National Institute of Health. Wayne State University/Detroit Medical Center is also participating in RAMPART.

The study will be conducted in conjunction with Detroit EMS. Any patient that is actively seizing upon arrival may be eligible to participate in the study. The patients must meet the inclusion and exclusion criteria of the study and be transported to either Henry Ford Hospital, Detroit Receiving Hospital, or Sinai-Grace Hospital to be included in the study. Other hospitals may be added later.

The Henry Ford Hospital Institutional Review Board (IRB) will review and monitor the study. Taher Vohra, M.D. and Christopher Lewandowski, M.D., both of the Department of Emergency Medicine at Henry Ford Hospital, are currently meeting with community groups to get their opinions on the study. Following these meetings, the Henry Ford Hospital IRB will review the process and determine final approval to conduct the study. The study is expected to start this summer.

For more information please visit www.detroitrampart.org.


'/>"/>
SOURCE Henry Ford Hospital
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Grosse Pointes Cottage Hospital Joins Henry Ford Health System
2. CNS Response, Inc. Names Henry T. Harbin, MD to Board of Directors
3. Fund-Raiser for Henry Ford Hospitals Stroke Program
4. Program for Stroke Survivors and Friends Hosted by Henry Ford Hospital
5. Repligen Elects Earl Henry, M.D. to the Board of Directors
6. Michigan Quality Council (MQC) Names Henry Ford Health System 2007 State Quality Award Recipient
7. AAPD to Present 2008 Henry B. Betts Award to International Human Rights Disability Advocate Eric Rosenthal
8. Cardiac Science Announces HeartCentrix(R) ECG Informatics Connectivity With Henry Schein Medical Systems MicroMD(R) EMR 5.0
9. Henry Ford Hospital expands research on gene and radiation therapy for prostate cancer
10. Henry Ford Hospital to study effectiveness of a new procedure that may help emphysema suffers
11. Stella Mora Henry to Present The Eldercare Handbook at Aging in America Joint Conference of National Council on Aging & The American Society on Aging March 27-29
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 13, 2017 , ... As health professionals work to improve their approach to ... is doing more than filling out a survey; in many cases health professionals and ... in health care and research on the importance of active engagement with patients and ...
(Date:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Lori R. Somekh, ... member of ElderCounsel, a national organization of elder law and special needs planning attorneys. ... and rules. It also provides a forum to network with elder law attorneys nationwide,” ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, has released ... understood books in the Holy Scriptures, Revelation. The Book of Revelation paints a picture ... Many have tossed it off as mere rubbish, but Yisrayl Hawkins says that is ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans ... advance the use of wearable and home sensors for ... disorders. Early Signal Foundation, a nonprofit organization focused on ... will provide an affordable analytical system to record and ... ...
(Date:9/23/2017)... 22, 2017 Janssen Biotech, Inc. (Janssen) announced ... from the U.S. Food and Drug Administration (FDA) for ... for the treatment of moderately to severely active rheumatoid ... data are needed to further evaluate the safety of ... RA. "We ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
Breaking Medicine Technology: