Following the platelets aggregation inhibitory effect of aspirin pre- and post CABG, and the possible emergence of HAPR post CABG, measured with the VerifyNow Aspirin device.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the moment that the number of 20 study subjects is
reached and there have been five measurements of ARU with each patient.
Secondary outcome
-Average of ARU's per moment of measurement.
-Difference in the ARU's per individual at different measuring moments.
-The time of first postoperatively Aspirin gift.
-Number of platelets at each measurement moment.
-Number and amount of any per-and postoperative platelet transfusions.
-Possible post-operative interventions (such as PCI, re-CABG, etc.) until the
measuring time T5.
Background summary
Aspirin is used for the prevention of thromboembolic occlusion of the grafts
after a Coronary Artery Bypass Grafting after (CABG).
However multiple studies have shown that a significant part of the patients who
use Aspirin are low- or non-responder for Aspirin. This means that these
patients do not have the possible protective effect of aspirin on the grafts,
causing a greater chance of graft occlusion. There are several devices that can
measure the platelets aggregation inhibitory effect of aspirin and this can
give a clue whether there is High on-aspirin platelet reactivity (HAPR) in the
patients.
In this research is in 20 patients undergoing CABG looked at how they respond
to Aspirin using one of these devices (VerifyNow Aspirin).
The VerifyNow Aspirin measure the platelet response on Aspirin, this is shown
in Aspirin Response Units (ARU's).
If the low- or non-responders can be identified, this may be a reason to
replace Aspirin with another platelets aggregation inhibitory medium in these
patients.
Study objective
Following the platelets aggregation inhibitory effect of aspirin pre- and post
CABG, and the possible emergence of HAPR post CABG, measured with the VerifyNow
Aspirin device.
Study design
It is a pilot for a clinical research involving 20 patients who are undergoing
an elective CABG in UMC St Radboud,
These patients will be followed directly preoperative to six weeks
postoperatively.
During this time, there are five different moments where the level of platelets
inhibition is measured with the VerifyNow Aspirin and shown like the so-called
Aspirin Raction Unitis (ARU's).
The five measurement moments are:
- Measurement 1 (T1): Direct preoperative on the operating room before the
start of the operation.
- Measurement 2 (T2): on the operating room immediately postoperatively, after
the end of the operation.
- Measurement 3 (T3): on the morning of the first postoperative day.
- Measurement 4 (T4): on the morning of the second postoperative day.
- Measurement 5 (T5): six weeks postoperatively on the postoperative policlinic.
On the above mentioned moments is blood collected that will be analyzed through
the VerifyNow Aspirin.
At the moment the patients are included in the study (T0) and after the time
that patients have been on the postoperative policlinic(T5) the following
information is collected from the patient files and from the EPD:
-Number of platelets at each measurement.
-The time of first postoperatively Aspirin gift.
-Number and amount of any pre-, per- and postoperative platelet transfusions
-Postoperative blood loss.
-Comorbidities, relevance history or complications (e.g. CABG or PCI) and
patient characteristics.
Study burden and risks
The burden and/or risks for participation in this research are insignificant.
Blood for the first 3 measurements is collected from intravenous or
intra-arterial lines that the patient has around the operation. For the last 2
measurement the blood is collected trough a vein puncture.
In total there is about 15 ml more blood collected from the patient than the
standard patient who is undergoing a CABG surgery at the UMC St Radboud. For
the rest the study subjects has to answer a few questions at the postoperative
policlinic regarding the medication use , therapy compliance and possible
complications.
UMC St Radboud huispost 677
nijmegen 6500HB
NL
UMC St Radboud huispost 677
nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Elective pre-CABG patients (with during the CABG use of Heartlung machine)
Use of preoperative Aspirin
Exclusion criteria
Use of other platelets aggregation inhibiting medicines, NSAID'S, GPIIb/IIIa receptor antagonists, anticoagulants and/or heparines. (e.g., Dipyridamole, Acenocoumarol, Nadroparine, Plavix, etc.)
Under-age patients and minors.
Insufficient mastery of the Dutch or English to get wel informed.
Intolerance to aspirin.
Coagulation abnormalities, congenital platelets abnormalities and/or medication (non-aspirin) induced platelet abnormality
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 | NL41667.091.12 |