No registrations found.
ID
Source
Brief title
Health condition
Aortic dissection, both elective and emergency aortic surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of standard-of-care thromboelastometry with ROTEM® Delta and ROTEM® Sigma at different timepoints perioperatively, in patients undergoing elective and emergency aortic surgery
Secondary outcome
Incidence and degree of perioperative coagulation abnormalities, transfusion and coagulation factor requirements, complications, mortality, and morbidity up to 30 days postoperatively, in patients undergoing elective and emergency aortic surgery
Background summary
The aim of the present retrospective and prospective data collection is to estimate the incidence and degree of perioperative coagulation abnormalities using thromboelastometry (with both ROTEM® Delta and ROTEM® Sigma) as well as transfusion and coagulation factor requirements in patients undergoing aortic surgery (emergency and elective). We will collect data on patients scheduled for emergency surgery, due to acute type A aortic dissection and patients undergoing elective surgery of the aorta. Furthermore, we will compare the results from viscoelastic testing using ROTEM® Delta with ROTEM® Sigma.
The findings may help to optimize coagulation management in patients undergoing major aortic surgery, in order to minimize bleeding as well as thromboembolic complications, both of which can have devastating consequences in this high-risk patient population.
Study objective
The aim of the present retrospective and prospective data collection is to estimate the incidence and degree of perioperative coagulation abnormalities, using thromboelastometry (with both ROTEM® Delta and ROTEM® Sigma), as well as transfusion and coagulation factor requirements, in patients undergoing elective and emergency aortic surgery.
Study design
All available perioperative timepoints: T0 = Baseline (before aortic cross-clamp), T1 = after aortic cross-clamp, T2 = admission to ICU, T3 = post-op day 1 ICU, T4,5= (optional) daily on ICU until discharge from ICU, T6 = 30 day follow-up for morbidity and mortality
Intervention
None
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Jennifer Breel
0610019257
j.s.breel@amsterdamumc.nl
Inclusion criteria
• Patients > 18 years
• Patients already operated on or scheduled for acute or elective aortic surgery in Amsterdam UMC, location AMC in period 01 January 2021 - 31 December 2021
• Willing and able to sign consent letter for the re-use of care data
Exclusion criteria
• Previous history of manifest coagulation disorders
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9530 |
| Other | METC AMC : W21_186#21.201 |