Notice Number: NOT-GM-14-112

Key Dates
Release Date: April 18, 2014
Response Date: May 30, 2014

Related Announcements
None

Issued by
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The Office of Emergency Care Research (OECR), located within the National Institute of General Medical Sciences, is responsible for coordinating and fostering NIH support for clinical and translational research and research training for the emergency setting. The National Heart, Lung, and Blood Institute the National Institute for Neurological Disorders and Stroke and the Office of Emergency Care Research seek comments regarding the clinical research questions surrounding post-resuscitation hypothermia. This Request for Information (RFI) will help assist staff to promote studies that will provide answers to the most pressing questions raised by clinicians and researchers.

Background

Post cardiac arrest hypothermia was shown to improve neurological outcomes in two studies performed in Australia and Europe and reported in 2002 (NEJM 2002, 346:549-563 and NEJM 2002, 346:557-563). The 2010 American Heart Association Guidelines recommend that therapeutic hypothermia be used for comatose adults with a pulse following out of hospital cardiac arrest (Circulation 2010;122: Suppl 3:S768-S786), and a 2012 Cochrane review concluded that mild therapeutic hypothermia improves survival and neurologic outcome after cardiac arrest (Cochrane Database of Systematic Reviews 2012, Issue 9). More recently, two studies have questioned both the timing and level of hypothermia (JAMA. 2014;311(1):45-52 and NEJM 2013;369:2197-206), and questions appear to remain as to whether the hypothermia is more beneficial than strict maintenance of normothermia.

Information Requested

This RFI solicits feedback from the scientific research communities and other interested organizations, on the clinical research questions that need to be answered surrounding post resuscitation therapeutic hypothermia. Comments may include but are not limited to the following areas of concern:

• The most pressing scientific questions about the utility of hypothermia after cardiac arrest.
• Ethical issues surrounding a clinical trial that studies strict normothermia vs. hypothermia, if any.
• Features of temperature management in post arrest patients that are most critical to study next, i.e., optimal temperature, optimal duration, hypothermia vs. normothermia as well as any other factors that are more important to study.
• Confinement of the patients in the next stage of hypothermia studies without hospital VF arrest.
• Methods of controlling temperature that should be used in next stage studies of temperature management after cardiac arrest; i.e. surface cooling, intravascular cooling, neurological cooling, accompanying medications, etc.
• The study endpoints that should/could be used.
• Evaluation of re-warming strategies, if applicable.

How to Submit a Response

Responses to the RFI will be accepted until May 30, 2014. You will not receive individualized feedback on any suggestions. No basis for claims against the United States government shall arise as a result of a response to this request for information or from the Unites States government’s use of such information.

All comments must be submitted via email as text or as an attached electronic document. Microsoft Word documents are preferred. Please submit your response to:

Jeremy Brown MD
Office of Emergency Care Research
Telephone: 301-594-2755
Email: [email protected]

Response to this RFI is voluntary. All interested parties are invited to respond. Any personal identifiers (e.g. names, addresses, email addresses,) will be removed when responses are compiled. Only the de-identified comments will be used. Proprietary, classified, confidential, or sensitive information should not be included in your response. The United States government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States government to provide support for any ideas identified in response to it. Please note that the United States government will not pay for the preparation of any information submitted or for its use of that information. Responses will be compiled and shared internally with staff from the NHLBI, NINDS and OECR, and with scientific working groups convened by these bodies as appropriate. In all cases where responses are shared, the names of the respondents will be withheld.

Inquiries

Please direct all inquiries to:

Jeremy Brown MD
Office of Emergency Care Research
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2755
Email: [email protected]