INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure Trial

It is best to provide us with separate feasibility forms (we can provide as many links as necessary) to identify individuals we will need to know to perform the study/shipments, etc. If a network of sites identify the same central contracting officer, REB address, etc. that's ok, simply provide that information in the appropriate sections. We'll assign an individual site ID number as necessary for logistical purposes and documentation of regulatory/GCP training, and ability to manage study drug, reporting purposes, etc.

eSOCDAT: A study coordinator at each site has been granted eSOCDAT access. They can create and activate accounts for all peronnel at that site. OpenClinica: Frontier grants access by checking against the personnel log in eSOCDAT, so personnel should be in the system before requesting access. Frontier grants access within 3 days, but typically it's the same day or next.

​We will not be providing the kits as it is standard for hospitals to have this kind of equipment.

For eligibility, either a hospital history & physical or discharge summary is appropriate. Patient discharge paperwork is insufficient. Clinic notes or progress notes may be submitted in addition as supporting documentation. For endpoints, a discharge summary with investigator summary is requested. In the event of death, a death narrative is requested with autopsy report if available. The death narrative form can be found in the secure study portal. We do not routinely need separate labs or diagnostic reports.

With regards to medications, enrolled participants should meet the following: a) not already vaccinated with the flu shot for the current season; b) no active infection being treated with antibiotics (low-dose, suppressive antibiotics for a stable chronic condition is ok); c) no current use of inotropes. Use of inotropes is considered consistent with acutely decompensated HF and these patients should not be enrolled until their condition improves. When in doubt, simply email your network coordinator liaison.

GCP training from any valid, recognized source, with appropriate documentation that the CCC will review and sign off on is fine. In Canada, because the study is regulated by Health Canada, Division 5 training (offered by CITI) is required, as is Handling of Hazardous Materials training. These are considered fairly standard tasks for regulated trial conduct.

Patients on IV inotropes would still be considered acutely decompensated and should not be enrolled until their condition improves.

No, participants enrolled in a previous year may be re-enrolled as long as they do not meet any exclusion criteria.

There is no specific definition. Decompensation is deferred to the PI’s discretion. In general, once subjects are ready for discharge, they are considered no longer acutely decompensated.

Yes, as long as they are not currently acutely decompensated.

Yes, as long as they are no longer acutely decompensated. We suggest waiting until near discharge.

Yes. Prophylactic antibiotics are fine. Antibiotics for an acute infection would be an exclusion.

Yes. However, subjects who are undergoing a prolonged hospitalization prior to their transplant may be too acutely ill to be enrolled. We suggest waiting until the subject is at or near discharge or recruiting as an outpatient.