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Reduction of cerebral air microembolisation improves neuropsychological outcome after pulmonary endarterectomy

Reduction of cerebral air microembolisation improves neuropsychological outcome after pulmonary endarterectomy - N.E.O.C.A.R.E.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021499
Enrollment
100
Registered
2020-04-28
Start date
2012-04-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension, Pulmonary endarterectomy, Postoperative cognitive deficits

Interventions

Group 1: Intervention group (DBT): additional use of the dynamic bubble trap Group 2: Control group: no additional filter system

Sponsors

Heart and Brain Research Group, Kooperation des Universitätsklinikums Giessen und der Kerckhoff Klinik Bad Nauheim.Gesundheitszentrum Wetterau, Neurologie.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Elelective Pulmonary Endarterectomy - Patients aged 18 and older - Informed Consent - German as mother tongue

Exclusion criteria

Exclusion criteria: Any pre-existing neurological or psychiatric disease (in particular cerebral infarction, craniocerebral trauma, manifest depression or dementia) that may influence neuropsychological testing

Design outcomes

Primary

MeasureTime frame
As a primary endpoint, we will investigate whether or not the neuropsychological outcome was influenced by the use of the dynamic bubble trap (DBT). For this purpose, the neuropsychological outcome will be measured preoperatively and 3 months after surgery with a detailed, objective, neuropsychological test battery.

Secondary

MeasureTime frame
As secondary endpoints, subjective self- and foreign assessment of cognitive deficits, anxiety and depression as well as health-related quality of life will be assessed preoperatively and 3 months after surgery using standardized questionnaires. Postoperative cerebral micro-infarcts will be measured 6-10 days after surgery by diffusion-weighted MRI. The number of microemboli before and after the DBT will be measured with a gas bubble counter.

Countries

Germany

Contacts

Public ContactJasmin El Shazly

Heart and Brain Research Group, Kooperation des Universitätsklinikums Giessen und der Kerckhoff Klinik Bad Nauheim

jasmin.el-shazly@psychol.uni-giessen.de+496032-996 2557

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026