no explicit diagnostic encryption
Conditions
Interventions
Group 1: with Hemoclear filtered wound blood (positive control)
- Patient data: name, date of birth, height, weight, BMI, planned cesarean section appointment, reason for planned cesarean section, ge
Sponsors
CRS Medical GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - signed informed consent - planned caesarean section under spinal, epidural or general anesthesia
Exclusion criteria
Exclusion criteria: - unsigned informed consent - Congenital consent or platelet dysfunction - Factor V Leiden mutation - Acute bleeding tendency or coagulation disorder during pregnancy - Thrombocytopenia - Taking anticoagulants such as NOACs or heparin - Taking medications that affect platelet function such as ASA (acetylsalicylic acid) or NSAIDs (non-steroidal anti-inflammatory drugs) 3-7 days before caesarean section
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet function in filtered wound blood with Fluorescence activated cell sorting | — |
Secondary
| Measure | Time frame |
|---|---|
| - Handling, construction and washing process duration, practical procedure in the operating room, costs - analysis of processed wound blood regarding hematological parameters, inflammatory markers - analysis of non-inferiority compared to the current standard of centrifugation-based Autotransfusion | — |
Countries
Germany
Contacts
Public ContactAndrea Steinbicker
Uniklinik Köln
Outcome results
None listed