Navigation Links
Henry Ford Hospital: Unique Patient Study -- No Informed Consent

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

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:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief ... a minimum wage raise to $12 an hour by 2020 and then adjusting it yearly ... lost value of the minimum wage, assure the wage floor does not erode again, and ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
(Date:6/23/2016)... June 23, 2016 , , ... July 7, 2016 , , , , LOCATION: , , ... , , , EXPERT PANELISTS:  , , , Frost & ... Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, ... The global pharmaceutical industry is witnessing an exceptional era. Several new ...
(Date:6/23/2016)... PRINCETON, N.J. , June 23, 2016  Guerbet ... of Premier Inc.,s Supplier Horizon Award . ... this year, Guerbet was recognized for its support of ... value creation through clinical excellence, and commitment to lower ... delighted to receive this recognition of our outstanding customer ...
Breaking Medicine Technology: