Overview
The SUNDAY Trial is a randomized, open-label, observer-blinded, two-armed controlled study that addresses the question of whether thoracic endovascular aortic repair (TEVAR) impacts five-year survival among patients with an uncomplicated Stanford type-B aortic dissection.
It is investigator-driven, and patients will be randomized to either standard medical therapy (SMT) alone or SMT + subacute TEVAR. The primary outcome is five-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, reinterventions and readmissions. In addition, subgroup analyses based on the extent of aortic treatment will be investigated.
Schematic flow chart of how to include
Help with REDCap and Data Entry
Adverse Events
Readmissions
How to think about AEs
We have tried to simplify the adverse event reporting in REDCap, so that the column/instrument for adverse events is placed in only one column on the right-hand side. We also made it possible to link any adverse event to whatever follow-up or procedure that it is related. This makes the database less cluttered. The disadvantage, however, is that one needs to remember to evaluate for adverse events at every follow-up or readmission or reintervention. Many may forget or neglect to report this if a subject was admitted briefly and no intervention was required. It can also become confusing if a subject was readmitted for an adverse event and then an adverse event occurred during the readmission. What this means in practice is that one may need to complete an adverse evaluation leading up to a readmission, an adverse event evaluation during the readmission, and an adverse event evaluation if a procedure took place.
REMEMBER! Evaluate adverse events at every follow-up and any readmission or reintervention.
AE at primary discharge
- This is only for the primary admission, i.e., the time of stay at randomization. Once they are discharged, this form should never be used again.
AE at primary procedure
- This is the AE reporting only for the primary TEVAR. This is only for those subjects that were randomized to TEVAR. If the subject underwent TEVAR as a cross-over subject, then this reporting link should not be used.
AE at reintervention
- Evaluates adverse events related to any procedure other than the primary procedure. Complete one for each procedure, even if no adverse event occurred. Again, this is important, as we need to differentiate whether an adverse event during their hospital stay was linked to their procedure or not.
AE at 3M, 1Y, 3Y, and 5Y
- These reports need to be updated over follow-up, and the dates are self-explanatory. Many of these will typically be related to non-vascular disease, e.g., admitted with influenza. This gets noted as an adverse event, but there is no need to complete a readmission instrument.
AE leading to readmission
- Describes the reason for the readmission. Only one is required per readmission.
AE under/during readmission
- This is linked to any adverse event during the readmission stay that are not related to any vascular surgery procedure. Again, this is important, as we need to differentiate whether an adverse event during their hospital stay was linked to their procedure or not. Must be completed at the end of every readmission, even if no adverse event occurred.
Is it vascular-related?
Only vascular- or procedure-related readmissions should be reported using the Readmission instrument.
If the reason for admission is not vascular- or procedure-related (e.g., GI infections, AFib, pneumonia), it should not be registered as a readmission. Instead, complete an Adverse Event Evaluation and link it to the relevant follow-up visit.
If vascular-related
1) An Adverse Event Evaluation linked to “AE leading to readmission.”
→ Explains the reason for the admission. Only one per readmission.
2) A Readmission form
→ Describes the hospital stay and relevant investigations. Only one per readmission.
3a) Procedural data under the Procedure column
→ If a procedure was performed, register it here. This step can be repeated if more than one procedure took place.
3b) An Adverse Event Evaluation linked to “AE at reintervention”
→ Completed after each procedure to report potential adverse events — even if none occurred.
4) An Adverse Event Evaluation linked to “AE under/during readmission”
→ This must also be completed. The purpose here is to identify or differentiate whether any adverse event was related to any procedure that took place. This instrument is in place to capture any adverse event that was not procedurally related. Required even if there is no adverse event (in that case, select “no adverse event”).
Note: Step 3a and 3b should be repeated for each additional procedure during the same readmission.
Not vascular-related
It should not be registered as a readmission. Instead, complete an Adverse Event Evaluation and link it to the relevant follow-up visit.
Want to know more about Sunday Trial?
If you want to learn more about the SUNDAY Trial, you can download the detailed trial brochure in PDF format below. For additional questions or support, feel free to contact any of the participating centers or trial coordinators. We are dedicated to providing clear and transparent information to help you stay informed.
Got any questions?
Learn more about the trial, participating centers, and upcoming events below. If you have any questions, please feel free to contact us.