N/A
N=10
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT01319799 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery — 354 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Open heart surgery (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Sahlgrenska University Hospital
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery |
354 | — |
| SECONDARY Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter) |
0.11 | — |
Summary
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of new postoperative changes detected on MRI. Transcranial Doppler (TCD) has shown the occurrence of extensive microembolic signals in intracerebral arteries during open heart procedures (2). The clinical significance of cerebral microemboli is not clear (3-5). The use of serological markers to assess cerebral injury after open cardiac surgery is difficult to interpret. The levels of markers seems to be contaminated from extracerebral sources (6). In order assess the release of markers of neuronal damage after open aortic valve surgery the investigators intend to examine the levels of S-100B, NSE and Tau in cerebrospinal fluid (CSF) by comparing the levels preoperative with the levels one day after surgery. Furthermore the investigators will determine the total amount of cerebral microembolic signals during the surgical procedure by means of TCD. The investigators will statistically test if there is any correlation between the increase in cerebrospinal fluid levels of S-100B,NSE and Tau and the cerebral embolic load.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis aortic stenosis eligible for surgical treatment
Exclusion Criteria
- Coagulopathy
- Regular Anticoagulation therapy
- Carotid stenosis
Data sourced from ClinicalTrials.gov (NCT01319799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.