Notice Number: NOT-HL-18-653
Key Dates
Release Date: September 07, 2018
None
Issued by
National Heart, Lung, and Blood Institute (NHLBI)
Purpose
The goal of this Request for Information (RFI) is to solicit input regarding current practices for lung transplant donor and recipient management and assessment during the pre-, peri-, and post-operative periods. Information from this RFI will be used to strategically identify areas of clinical assessment and management that could be optimized to promote research in lung transplantation.
Background
Demand for lung transplantation is steadily increasing as the only available end-stage therapy for many chronic lung diseases such as cystic fibrosis, pulmonary arterial hypertension, chronic obstructive pulmonary disease, and idiopathic pulmonary fibrosis. Yet, clinical outcomes following lung transplantation lag in comparison to those of other solid organs including the liver, kidney, and heart.
To identify clinical research priorities aimed at improving survival as well as quality-of-life following lung transplantation, the NHLBI co-sponsored a workshop in June 2017 with the American Association of Thoracic Surgeons (AATS) that brought together transplant surgeons, pulmonologists, ethicists, patient advocacy groups, and representatives from federal agencies with a vested interest in lung transplantation. A clear articulation of the workshop participants was that clinical management in lung transplant donors and recipients is not well standardized and varies widely across centers, in part due to the lack of evidence-based approaches. As a result, the workshop participants recommended ascertainment of the range of current practices in the assessment and management of donors and recipients as an important step towards facilitating clinical research in lung transplantation.
Information Requested
The NHLBI invites members of the health and scientific communities with an interest in lung transplantation to comment on any or all of their current practices for, but not limited to, the following:
1. Donor assessment and management:
- Clinical data and biospecimens collected
- Timing and frequency of data and biospecimen collection
- Methods for data and biospecimen collection
- Criteria used for determining donor organ suitability
- Clinical management approach
- Strategy for pre-transplant ventilation
- Organ transport and storage methods
- Strategy for use of ex vivo lung perfusion
2. Recipient assessment and management up to and beyond one-year post-transplant:
- Clinical data and biospecimens collected
- Timing and frequency of data and biospecimen collection
- Methods for data and biospecimen collection
- Pharmacologic/immunosuppressive management approach
- Strategy for post-transplant ventilation
- Diagnostic criteria for acute (e.g. primary graft dysfunction, acute cellular rejection, antibody-mediate rejection) and chronic (e.g. bronchiolitis obliterans syndrome, restrictive allograft syndrome) lung allograft dysfunction
- Treatment approaches for mitigating acute and chronic lung allograft dysfunction
Submitting a Response
All responses must be submitted via email to NHLBI_LTRFI@mail.nih.gov by November 30, 2018. Please include the Notice number NOT-HL-18-653 in the subject line. The submitted information will be reviewed by NIH staff.
Responses to this RFI are voluntary. Please do not include any proprietary, classified, confidential, or sensitive information in your response. NIH will use information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission.
The government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use information gathered by this RFI to inform development of future funding opportunity announcements.
This RFI is for information and planning purposes only and should not be construed as a solicitation or an obligation on the part of the Federal Government, the National Institutes of Health (NIH), or individual NIH institutes and Centers. NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response or from the Government’s use of such information.Inquiries
Please direct all inquiries to:
Matt Craig, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7841
Email: matt.craig@nih.gov
Neil Aggarwal, M.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-7820
Email: neil.aggarwal@nih.gov
and Human Services (HHS)
