Opportunity Information: Apply for RFA HL 11 036
Apply for RFA HL 11 036
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition Revision for Resuscitation Outcomes Center Randomized Clinical Trial (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837 Cardiovascular Diseases Research.
- This funding opportunity was created on Mar 2, 2011 and posted on Mar 2, 2011.
- Applicants must submit their applications by May 3, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following Only the currently funded NHLBI Resuscitation Outcomes Centers are eligible to apply.
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Opportunity Summary:
This funding opportunity (RFA-HL-11-036) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) announcement for a limited-competition Revision award under a cooperative agreement mechanism (U01). It was posted on March 2, 2011, and closed May 3, 2011 (archived June 3, 2011). The program sits within the NIH health research portfolio and is associated with CFDA 93.837, Cardiovascular Diseases Research. There is no cost sharing or matching requirement.
The purpose of the announcement is very specific: NHLBI is inviting applications to revise and expand the scope of ongoing work within the Resuscitation Outcomes Consortium (ROC), originally funded under RFA-HL-10-006. The revision is intended to support a multi-center, randomized, Phase III clinical trial focused on resuscitation and transfusion strategy in severely injured or critically ill patients who are expected to require massive blood transfusion. In practical terms, the trial is designed to test whether giving a higher early ratio of plasma and platelets relative to red blood cells improves acute survival compared with lower ratios. The high-ratio strategy is described as a 1:1:1 ratio of plasma:platelets:RBCs, and it will be compared against lower ratio strategies such as 1:1:2 or 1:1:3 (with RBCs being more predominant in the comparator arms). The central question is whether front-loading plasma and platelets to approximate whole-blood-like resuscitation improves near-term survival outcomes in patients predicted to undergo massive transfusion, a population at high risk of hemorrhagic shock, coagulopathy, and early mortality.
Because this is a cooperative agreement (U01), the expectation is that NHLBI will have substantial scientific and programmatic involvement in how the study is carried out, beyond what is typical for a standard research project grant. That generally implies close coordination with the Institute and across the consortium, common protocols, shared data and safety oversight structures, and harmonized operations across participating sites to ensure consistent enrollment, randomization, transfusion delivery, outcome measurement, and reporting.
Eligibility is restricted. This is a limited competition opportunity open only to the currently funded NHLBI Resuscitation Outcomes Centers. In other words, outside institutions that are not already funded ROC centers are not eligible to apply, even if they have relevant expertise. The eligible applicant category in the listing is shown as "Others (see text field...)," with the clarifying restriction that only the existing NHLBI ROC centers may submit applications.
From a program design standpoint, the announcement emphasizes a large, multi-center, randomized Phase III trial, which implies a definitive, practice-informing study rather than an early feasibility effort. The focus on patients predicted to need massive transfusion also signals an interest in intervening very early in the course of hemorrhage management, when transfusion decisions can most plausibly influence survival. The "acute survival benefits" language indicates that the primary outcomes are likely short-term mortality endpoints (for example, early in-hospital or early post-injury survival), rather than longer-term functional outcomes, although full details would be contained in the complete FOA.
Administrative details included in the source summary identify the NIH Office of Extramural Research (OER) as the contact point for technical issues accessing or linking to the announcement, via the OER webmaster email addresses provided. The full announcement was hosted on the NIH grants guide site at the link included in the opportunity record.
Funding Opportunity FAQs (RFA-HL-11-036)
What is RFA-HL-11-036?
RFA-HL-11-036 is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding opportunity announcement for a limited-competition Revision award under a cooperative agreement mechanism (U01).
Which NIH institute is sponsoring this opportunity?
This opportunity is sponsored by the NIH National Heart, Lung, and Blood Institute (NHLBI).
What type of award mechanism is used?
The mechanism is a cooperative agreement (U01). This structure typically involves substantial scientific and programmatic involvement from NHLBI during study conduct, beyond what is typical for a standard research project grant.
Is this a new award or a revision to an existing project?
It is a Revision award intended to revise and expand the scope of ongoing work within the Resuscitation Outcomes Consortium (ROC) that was originally funded under RFA-HL-10-006.
What is the main purpose of the revision?
The purpose is to support a large, multi-center, randomized Phase III clinical trial focused on resuscitation and transfusion strategy in severely injured or critically ill patients expected to require massive blood transfusion.
What clinical question is the trial trying to answer?
The trial is designed to test whether giving a higher early ratio of plasma and platelets relative to red blood cells improves acute survival compared with lower ratio strategies.
What transfusion ratios are described in the announcement?
The high-ratio strategy is described as a 1:1:1 ratio of plasma:platelets:red blood cells (RBCs). Comparator strategies include lower ratios such as 1:1:2 or 1:1:3, where RBCs are more predominant than in the high-ratio strategy.
What patient population is the trial focused on?
The focus is on severely injured or critically ill patients who are predicted to need massive transfusion, a population at high risk of hemorrhagic shock, coagulopathy, and early mortality.
Why does the announcement emphasize early transfusion strategy?
Because it targets patients predicted to undergo massive transfusion, the intent is to intervene very early in hemorrhage management, when transfusion decisions are most likely to influence near-term survival.
What phase of clinical trial is being proposed?
The announcement calls for a Phase III clinical trial, which generally implies a definitive, practice-informing, multi-center randomized study rather than an early feasibility effort.
What outcomes are emphasized?
The announcement highlights "acute survival benefits," suggesting primary outcomes centered on short-term mortality endpoints (for example, early in-hospital or early post-injury survival). Full outcome definitions would be specified in the complete funding announcement.
How is this opportunity categorized in federal assistance listings?
It is associated with CFDA 93.837, Cardiovascular Diseases Research.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is restricted to currently funded NHLBI Resuscitation Outcomes Centers (ROC). Institutions that are not existing ROC centers are not eligible to apply under this limited competition.
Can an institution outside the ROC apply if it has relevant expertise?
No. The announcement specifies this is a limited competition open only to currently funded NHLBI ROC centers.
What does "limited competition" mean in this context?
It means the applicant pool is restricted. Only the specified group (the currently funded NHLBI ROC centers) may submit applications.
What does the cooperative agreement structure imply for how the trial is run?
Because this is a U01 cooperative agreement, the expectation is close coordination with NHLBI and across the consortium, including common protocols, shared data and safety oversight structures, and harmonized operations across participating sites to support consistent enrollment, randomization, transfusion delivery, outcome measurement, and reporting.
When was this funding opportunity posted, and when did it close?
It was posted on March 2, 2011, and closed on May 3, 2011. It was archived on June 3, 2011.
Is this opportunity still open?
No. Based on the posted close date (May 3, 2011) and the archive date (June 3, 2011), this funding opportunity is closed and archived.
Where was the full announcement hosted?
The full announcement was hosted on the NIH Grants Guide website at the link included in the opportunity record.
Who is listed as the contact for technical issues accessing or linking to the announcement?
The administrative details identify the NIH Office of Extramural Research (OER) as the contact point for technical issues, via the OER webmaster email addresses provided in the source summary.
What consortium is this work associated with?
The revision is specifically tied to the Resuscitation Outcomes Consortium (ROC), and is intended to revise and expand ongoing ROC work originally funded under RFA-HL-10-006.
What is the practical idea behind the 1:1:1 strategy described?
The 1:1:1 strategy is described as front-loading plasma and platelets relative to RBCs to approximate whole-blood-like resuscitation, with the goal of improving near-term survival in patients expected to need massive transfusion.
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