1. To determine if pre-operative/post-operative platelet function/activation is associated with peak postoperative cTn levels. 2. To determine if peak postoperative inflammatory biomarker levels (IL-6, hs-CRP) are associated with peak postoperative…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peak postoperative cardiac troponin level
Secondary outcome
Length of stay, myocardial infarction, stroke, death during hospital stay.
Background summary
Asymptomatic cardiac troponin (cTn) elevation after major non-cardiac surgery
is a strong predictor of postoperative morbidity and mortality. (1,2) However,
the aetiology of such postoperative myocardial injury (PMI) remains unclear.
Currently, it is believed that PMI is primarily attributable to an oxygen
supply / demand mismatch in the presence of pre-existent coronary artery
disease or - less often - of rupture of an atherosclerotic plaque leading to
epicardial thrombosis and thromboembolism. (3) Platelets play a key role in
hemostasis and thrombosis and (on-treatment) platelet reactivity has been
demonstrated to be associated with the occurrence of atherothrombotic events.
Whether or not platelet reactivity plays a role in the pathophysiology of PMI
is unknown.
Study objective
1. To determine if pre-operative/post-operative platelet function/activation is
associated with peak postoperative cTn levels.
2. To determine if peak postoperative inflammatory biomarker levels (IL-6,
hs-CRP) are associated with peak postoperative cTn levels.
Study design
single center, observational cohort study
Study burden and risks
All patients will undergo routine anesthesia screening at the outpatient
clinic, during which general cardiac and pulmonary risk factors are evaluated
and a standardized physical examination is performed. At time of pre-operative
hospital admission a baseline ECG is performed for study purposes. In the OR an
arterial line is placed (routine care) and the first additional blood samples
are collected for study purposes. Patients are transferred to the ICU after
surgery (routine care). At time of ICU admission and at 24 and 48 hours after
surgery additional blood samples are collected for study purposes. After 48
hours no more visits of the research team are performed. Patients are followed
up using the electronic patient file until hospital discharge, with a maximum
of 30 days.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
Patient must meet ALL of the following criteria:
* Males or females > 21 years of age and < 85 years
* Undergoing elective open abdominal vascular surgery
* On pre-operative ascal maintenance therapy
Exclusion criteria
1) Patients who are unable to give informed consent or have life expectancy of < 1year
2) Subjects who have received thrombolytic therapy within 24 hours or GpIIb/IIIa-inhibitors within last 30 days
3) Subjects who had an acute coronary syndrome within the last 30 days
4) Subjects with a contra-indication to anticoagulation or at increased bleeding risk
a. Past or present history (<1 year) of bleeding from gastrointestinal (haematemesis) melena, frank bleed in stool or visible haematuria
b. Known platelet count (<100,00/mm3 ) or coagulopathy or platelet disorder
c. History of major recent (<30 day) surgery or trauma
5) Known Hb <6.5 mmol/L11g/dl or HCT <33%
Design
Recruitment
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 |
|---|---|
| CCMO | NL57157.100.16 |