No registrations found.
ID
Source
Brief title
Health condition
stroke
carotic endarterectomy
blood coagulation
platelet reactivity
beroerte
carotis endarteriectomie
bloedstolling
plaatjesfunctie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of MES signals (mean and SD) during TCD monitoring start from the first postoperative hour during a period of 3 hours in relation to thrombogenicity and platelet reactivity
Secondary outcome
- Postoperative stroke in realtion to thrombogeniticity and platlet reactivity during 1 year follow-up
- Postoperative stroke (asymptomatic) during 7 days follow-up starting from operation day, detected by MRI
Background summary
100 patients undergoing carotid endarterectomy will be included in the study. Before the surgical intervention coagulation parameters and platelet function will be determined using different laboratory test. Durin operation one more blood samplewill be obtained,10 minutes after the injection of heparin. After the operation patients will be monitored using TCD, starting from the first postoperative hour during 3 hours. Subsequently we will investigate whether or not there is a correlation between the markers and the amount of postoperative MES. Also correlations between markers and the occurence of stroke will be investigated. There will be a follow-up period of 1 year.
Study objective
High thrombogenicity and platelet reactivity are risk factors for postoperative micro-emboli on transcranial doppler and postoperative strokes.
Study design
T1= operation day -1: blood sample
T2= during operation: blood sample
T3= first 3 hours after the operation: TCD
T4= operation day +7: MRI cerebrum
T5= operation day + 365: clinical follow-up
Intervention
1) 2 bloodsamples at T1 and T2 for Callibrated Automated Thrombogram and for coagulation factors and platet function tests.
2) Transcranial Doppler sonography at T3. The amount of MES are measured during a period of 3 hours starting from the first postoperative hour.
3) MRI at T4
Department of Biochemistry K4.360
K. Winckers
Universiteitssingel 50
Maastricht 6229 ER
The Netherlands
+31 (0)43 3881685
kristien.winckers@bioch.unimaas.nl
Department of Biochemistry K4.360
K. Winckers
Universiteitssingel 50
Maastricht 6229 ER
The Netherlands
+31 (0)43 3881685
kristien.winckers@bioch.unimaas.nl
Inclusion criteria
1. Patients with an ischemic stroke or TIA (first episode or recurrent disease) AND:
an ipislateral stenosis of the carotid artery for which operation of the carotid artery is indicated.
2. Patients need to have an adequate transtemporal window for TCD monitoring og the ateria cerebri media
Exclusion criteria
1. Proven coagulopathies
2. Pregnancy
3. Active infections
4. Chronic inflammatory diseases
5. Anti-phospholipid syndrome
6. Active malignancy
7. Recent cardiovascular intervention (< 3 months)
8. Cardiac arrythmias
9. Postradiation stenosis of the carotid artery
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 |
|---|---|
| NTR-new | NL1412 |
| NTR-old | NTR1472 |
| Other | 23681 : MEC08-3-061 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |