Non-clinical evaluation of HemoClear blood filter in Intrapartum Care
Research type
Research Study
Full title
Use of the HemoClear system for obstetric cell salvage: A pre-clinical proof of concept to cleanse blood salvaged in caesarean sections and vaginal delivery
IRAS ID
294144
Contact name
Dion Osemwengie
Contact email
Sponsor organisation
HemoClear B.V.
ISRCTN Number
ISRCTN10504710
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Intraoperative cell salvage is the collection of own shed blood to processes and return it to the same person. Cell salvage reduces the infectious and allergenic risks associated with donor blood transfusion, it is recommended in medical guidelines. Maternal mortality is unacceptably high. About 295 000 women died during and following
pregnancy and childbirth in 2017. As the leading cause for these unnecessary deaths is severe bleeding (mostly bleeding after childbirth), broad use of cell salvage in during deliveries has lifesaving potential.
Current gold standard cell salvage devices (generally referred to as 'cell savers') are costly, require a trained operator.
Due to this they are often not available, not affordable or not practical. The novel HemoClear device is an accessible cell salvage filter that allows preparation of shed blood for reinfusion in a simple, cost-effective procedure. Without the need for extensive training, consumables or electricity. This benchtop, non-clinical study aims at investigating the HemoClear device performance in the obstetric field. To this
end, collected shed blood from 18 women undergoing caesarean section or vaginal delivery will be cleansed. In a paired setup, half of each sample will be processed with the HemoClear device and the other half with a gold standard cell saver. Pre-processed and processed blood quality will be analyzed to determine washing effeciency and compare the novel HemoClear device with the cell saver. No blood components are returned to any patient, no clinical data will be collected.REC name
HSC REC A
REC reference
21/NI/0015
Date of REC Opinion
9 Feb 2021
REC opinion
Further Information Favourable Opinion