Comparing the latest HemoClear blood washing system to a gold standard centrifugal washing system for the preparation of women’s own lost blood for safe reinfusion after vaginal deliveries and caesarean sections
Not Applicable
Completed
- Conditions
- Vaginal deliveries and caesarean sectionsPregnancy and Childbirth
- Registration Number
- ISRCTN10504710
- Lead Sponsor
- HemoClear B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 11
Inclusion Criteria
1. Women giving assisted vaginal birth or undergoing caesarean section.
2. Women losing between 500 and 1500 mL of shed blood
Exclusion Criteria
1. Any patient undergoing caesarean section where cell salvage is clinically indicated and standard practice at West Middlesex University Hospital (i.e. placenta praevia major, the patient is a Jehovah’s Witness etc)
2. Any patients with significant haemoglobinopathy (such as sickle-cell or thalassaemia) where red cell fragility may
be an issue
3. Any patients taking intrapartum antibiotics
4. Any patient with an active diagnosis of cancer
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The novel HemoClear device's washing efficiency statistical comparability to the gold standard cell saver, measured using the statistical difference in the amounts of blood cells and non-cellular components after processing with HemoClear compared to processing with the gold standard device
- Secondary Outcome Measures
Name Time Method