Trial Outcomes & Findings for Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement (NCT NCT01319799)

Results Overview

Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

(day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance

Results posted on

2017-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Surgical Aortic Valve Replacement Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Aortic Valve Replacement n=10 Participants Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	75 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Sweden	10 participants n=5 Participants

PRIMARY outcome

Timeframe: (day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance

Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.

Outcome measures

Outcome measures
Measure	Surgical Aortic Valve Replacement n=10 Participants Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery	354 units on a scale Standard Error 79

SECONDARY outcome

Timeframe: 24 Hours after Surgery

Differences in preoperative vs postoperative CSF levels of S-100B in microgram/Liter The assumption is that a cardiac open heart surgical procedure with cardiopulmonary bypass will influence the postoperative level of marker of neuronal cell damage in the central nerve system. An increase in the levels, compared to the preoperative values, indicates neuronal cell damage detectable in the CSF, namely the brains own extracellular fluid.

Outcome measures

Outcome measures
Measure	Surgical Aortic Valve Replacement n=10 Participants Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)	0.11 microgram/Liter Standard Error 0.02

Adverse Events

Surgical Aortic Valve Replacement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Bjorn Reinsfelt

Sahlgrenska University Hospital,Cardiothoracic Anesthesia, 41345 Gothenburg ,SWEDEN

Phone: 0046702954263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place