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N/A N=10

Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement

Aortic Stenosis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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