1. Determine whether thrombo-elastography (TEG) the occurrence of postoperative blood loss and transfusions can predict after cardiac surgery.2. Determine whether platelet aggregometry (Multiplate and Verify Now) can predict the occurrence of…
ID
Source
Brief title
Condition
- Platelet disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as the total amount of blood loss during the
first six hours after the operation
Secondary outcome
Secondary end-points are the total amount of blood loss during the first 12 and
24 hours after the operation, the number of transfused allogeneic blood
products during the first 24 hours post-surgery, post-operative bleeding
complications during hospitalization and re-operation due to a bleeding
complication during the post-operative hospital stay.
Background summary
Cardiothoracic surgery is associated with blood loss and an increased risk of
impaired coagulation by the use of a cardiopulmonary bypass (CPB). Coagulation
is a process of primary hemostasis platelet adhesion and aggregation, followed
by secondary
plasmatic coagulation and fibrin formation. Use of the CPB induces
thrombocytopathy.
For the prevention of thromboembolic events CABG patients are preoperatively
regularly treated with platelet aggregation inhibitors (APT = anti-platelet
therapy). APT is in accordance with international guidelines perioperatively
continued with an increased risk of bleeding complications, especially in
continuing the P2Y12 inhibitors. The effect of APT is irreversible.
Point of Care clotting assay with platelet function tests give qualitative
information on platelet aggregation and can contribute positively to earlky
goal directed blood transfusion after cardiac surgery.
Study objective
1. Determine whether thrombo-elastography (TEG) the occurrence of postoperative
blood loss and transfusions can predict after cardiac surgery.
2. Determine whether platelet aggregometry (Multiplate and Verify Now) can
predict the occurrence of postoperative blood loss and transfusions after
cardiac surgery.
3. Definition of reference range for platelet aggregometry (Multiplate and
Verify Now Aspirin assay) in patients during cardiac surgery.
4. Determine the value of TEG, Multiplate and Verify Now comparing with
standard laboratory coagulation tests.
Study design
Single center, blinded observational study
Study burden and risks
This study is observational and does not affect the treatment. There is
informed consent required for participation.
Elective cardiac surgery is done under general anesthesia. The anesthetic
policy for a patient participating in the study, does not differ from a patient
who is not taking part in the study.
koekoekslaan 1
nieuwegein 3435 CM
NL
koekoekslaan 1
nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
• > 18 years
• mentally competent
• scheduled for CABG + (multiple) heart valve surgery or multiple valve surgery
• signed informed consent
Exclusion criteria
• congenital or acquired clotting disorder
• pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51434.100.14 |
| Other | NTR nummer volgt |
| OMON | NL-OMON21551 |