To determine the effects of surgical trauma on heparin sensitivity and hemostasis during coronary artery bypass grafting (CABG) and cardiac valve surgery.To determine the relation between hemostatic activation and the heparin dose responsiveness as…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in heparin sensitivity between patients undergoing CABG and cardiac
valve surgery
Differences in rotational thromboelastometry and platelet aggregometery between
groups
Heparin and protamine dosing
Secondary outcome
Classical coagulation tests (aPTT, PT, platelet count)
Hemoglobin, hematocrit
Demographic variables, fluid intake, perioperative medication
Surgical characteristics
Microparticles
Background summary
Anticoagulation during cardiac surgery is of vital importance to prevent
thrombin generation and blood clot formation from occurring during
cardiopulmonary bypass (CPB). Therefore, heparin is used to achieve
anticoagulation during cardiac surgery. However, heparin is known to inhibit
platelet function and promote fibrinolysis, which increases the risk of
perioperative bleeding.
In addition, after termination of CPB, heparin is reversed by protamine, which
in itself acts as an anticoagulant if administered in excess. For this reason,
anticoagulation during cardiac surgery should be precisely monitored.
Identifying risk factors associated with individual sensitivity to heparin is
of great importance to minimalize the risks of bleeding during cardiac surgery.
In this study, we hypothesize that surgical trauma may influence heparin
sensitivity. Therefore, we aim to assess the effects of coagulation of heparin
sensitivity on coagulation through thromboelastometry, platelet aggregometry,
enzyme-linked immunosorbent assays, determination of microparticles and heparin
dose responsiveness measurements.
Study objective
To determine the effects of surgical trauma on heparin sensitivity and
hemostasis during coronary artery bypass grafting (CABG) and cardiac valve
surgery.
To determine the relation between hemostatic activation and the heparin dose
responsiveness as measured by the HepCon
Study design
Single center observational study in VUmc.
Study burden and risks
All described types of surgery, extracorporeal circulation and anticoagulation
monitoring are part of daily clinical practice in cardiothoracic surgery and
will not add up to patient burden. In total 56 ml of blood will be drawn from
the patient.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients scheduled for coronary artery bypass grafting (CABG) or cardiac valve surgery with cardiopulmonary bypass
Age 18-85 years
Informed consent
Exclusion criteria
Re-operations
Emergency operation
Patients with insulin-dependent diabetes mellitus
Patients with a history of hematologic, hepatic or renal diseases
Patients with Body Mass Index (BMI) over 30 kg/m2
Patients with anemia (Hb < 5.5 mmol/l)
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 | NL40680.029.12 |