Platelet function in filtered wound blood with combined mechanical autotransfusion of erythrocytes and platelets using HemoClear (CRS Medical) compared to platelet function in centrifuged wound blood using C.A.T.S. (Fresenius Kabi)
Recruiting
- Conditions
- no explicit diagnostic encryption
- Registration Number
- DRKS00034270
- Lead Sponsor
- CRS Medical GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 64
Inclusion Criteria
signed informed consent
- planned caesarean section under spinal, epidural or general anesthesia
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet function in filtered wound blood with Fluorescence activated cell sorting
- Secondary Outcome Measures
Name Time Method - Handling, construction and washing process duration, practical procedure in the operating room, costs<br>- analysis of processed wound blood regarding hematological parameters, inflammatory markers<br>- analysis of non-inferiority compared to the current standard of centrifugation-based Autotransfusion