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Thrombogenicity and platelet reactivity as risk factors for postoperative microemboli signals in patients undergoing carotid endarterectomy


- candidate number4165
- NTR NumberNTR1472
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2008
- Secondary IDsMEC08-3-061 23681
- Public TitleThrombogenicity and platelet reactivity as risk factors for postoperative microemboli signals in patients undergoing carotid endarterectomy
- Scientific TitleThrombogenicity and platelet reactivity as risk factors for postoperative microemboli signals in patients undergoing carotid endarterectomy
- ACRONYMMES-study
- hypothesisHigh thrombogenicity and platelet reactivity are risk factors for postoperative micro-emboli on transcranial doppler and postoperative strokes.
- Healt Condition(s) or Problem(s) studiedStroke, Blood coagulation, Stroke, Endarterectomy , Platelet reactivity
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jan-2012
- Target number of participants100
- Interventions1) 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
- Primary outcomeAmount 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
- TimepointsT1= 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
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. K. Winckers
- CONTACT for SCIENTIFIC QUERIESDrs. K. Winckers
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsN/A
- Brief summary100 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.
- Main changes (audit trail)
- RECORD2-okt-2008 - 14-okt-2008


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