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
| ISRCTN | ISRCTN10504710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10504710 |
| IRAS number | 294144 |
| Secondary identifying numbers | CPMS 48128, IRAS 294144 |
- Submission date
- 11/06/2021
- Registration date
- 20/08/2021
- Last edited
- 16/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In the developing world many people don’t have access to donated blood products. If they lose a lot of blood, for instance after the delivery of a baby, the safe return of their own blood could be lifesaving. However, in order to safely give back lost blood it should first be washed to get rid of the unwanted components, such as bacteria. A device IS used to clean and purify any lost blood so that it is safe to be given back to the mother after delivery should she need it. In comparison with the current cell salvage device the new HemoClear device is a simple filter that is intended to make cell salvage more affordable and available to all around the world. The aim of this study is to use collected blood lost after vaginal and caesarean deliveries and process it with the new HemoClear device and the currently used blood salvage machine. The study is a non-clinical pilot, meaning that the research staff are only running tests on the collected shed blood in the hospital laboratory, and participation will not have any effect on the clinical care participants will receive.
Who can participate?
Pregnant women over the age of 18 years
What does the study involve?
At the time participants are delivering their baby, one of the research team at the hospital will be informed that they are about to have a baby. If they’re having a caesarean section, during the operation any lost blood is suctioned into a blood collection reservoir. This is a standard procedure that also occurs outside of the research. Instead of throwing the blood away as normally happens, the research team will add a drug called heparin to the suction container (to stop the blood from clotting) and then after the caesarean was complete, take the suction container for processing and analysis. If participants have an assisted vaginal birth, an under-buttock sterile drape is placed as standard to collect any blood lost for measuring purposes. Once the baby is born, the blood in the drape is removed and collected in a sterile container for processing and analysis. After tests are performed and the results reported all blood samples will be destroyed. No samples are stored after the completion of the study.
What are the possible benefits and risks of participating?
The blood collected will only be used for investigation in a laboratory to compare the performances of the two devices and will not be given back to participants. There will be no direct health benefits for participants other than to contribute to improved health care for mothers around the world. There also aren’t any health disadvantages or risks to participants’ health arising from taking part in the study.
Where is the study run from?
Chelsea and Westminster Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2021 to January 2023
Who is funding the study?
European Commission
Who is the main contact?
Dr Philip Barclay
Philip.barclay@nhs.net
Contact information
Scientific
Anaesthetic Department
West Middlesex University Hospital
Twickenham Road
Isleworth
TW7 6AF
United Kingdom
 ORCID ID |
0000-0001-8278-7182 |
|---|---|
| Phone | +44 (0)20 8321 6285 |
| Philip.barclay@nhs.net |
Scientific
Dokter Stolteweg 70
Zwolle
8025 AZ
Netherlands
| Phone | +31 (0)618 692 328 |
|---|---|
| dion.osemwengie@hemoclear.com |
Study information
| Study design | Observational clinical laboratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Clinical laboratory study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study objectives | The simple, accessible, and cost-effective HemoClear blood salvage filter performs equally well as the gold standard centrifugal salvage device in salvaging red blood cells and washing out harmful non-cellular components. |
| Ethics approval(s) | Approved 09/02/2021, Health and Social Care Research Ethics Committee A (HSC REC A; Office for Research Ethics Committees Northern Ireland (ORECNI), Customer Care & Performance Directorate, Unit 4, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, BT28 2RF, UK; +44 (0)28 9536 1400; prs@hscni.net), REC ref: 21/NI/0015 |
| Health condition(s) or problem(s) studied | Vaginal deliveries and caesarean sections |
| Intervention | Consenting and collecting participants' samples Consent will be sought from women scheduled that are about to have a caesarean section or go through assisted vaginal delivery. Collection and measure of blood lost at caesarean section and assisted vaginal births is standard practice. Once delivery is complete, the collected blood in the drape will be transferred by a member of the research team for processing. No clinical or demographic data is collected for any participant. Processing with cell salvage devices Prior to processing a small volume of each shed blood volume is taken to determine the blood quality by means of several laboratory analyses. Next the shed blood volume collected from each participant is split into two. The first half is processed with a gold standard cell saver device and the second half is processed with the HemoClear device. The processed blood volumes are taken to the laboratory and analyzed as well. Upon completion of the analysis all blood samples will be discarded. Statistical analysis To determine the washing effectivity and comparability of the two washing devices, statistical analysis will be performed with the laboratory results. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 | 1. Percentage of maternal blood cells recovered by each device measured by complete blood counts using a haematology analyser, prior to processing of the shed blood and after processing with each device 2. Percentage of neonatal blood cells recovered by each device measured using the Kleihauer-Betke tests, prior to processing of the shed blood and after processing with each device 3. Percentage of alpha-fetoprotein washed out by each device as a marker of amniotic fluid content measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 4. Percentage of bacterial load washed out by each device measured using a microbial detection system, prior to processing of the shed blood and after processing with each device 5. Percentage of albumin washed out by each device as a general marker of washing efficiency and removal of proteins, measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 6. Percentage of lactate dehydrogenase washed out by each device as a market of the amount of dead red blood cells measured using a chemistry analyser, prior to processing of the shed blood and after processing with each device 7. Percentage of heparin washed out by each device as a marker of coagulation, measured using a coagulometer, prior to processing of the shed blood and after processing with each device 8. The effect on the coagulation profile of the blood cells by each device measured by activated partial thromboplastin time and prothrombin time using a coagulometer, prior to processing of the shed blood and after processing with each device |
| Overall study start date | 01/02/2021 |
| Completion date | 01/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 18; UK Sample Size: 18 |
| Total final enrolment | 11 |
| Key inclusion criteria | 1. Women giving assisted vaginal birth or undergoing caesarean section. 2. Women losing between 500 and 1500 mL of shed blood |
| Key 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 |
| Date of first enrolment | 27/07/2021 |
| Date of final enrolment | 01/01/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
369 Fulham Road
London
SW10 9NH
United Kingdom
Sponsor information
Industry
Dokter Stolteweg 70 A
Zwolle
8025AZ
Netherlands
| Phone | +31 (0)611261043 |
|---|---|
| dion.osemwengie@hemoclear.com |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. No additional documents available. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/01/2023: The final enrolment number has been added.
05/10/2022: The following changes were made to the trial record and the plain English summary has been updated accordingly:
1. The recruitment end date was changed from 01/09/2022 to 01/01/2023.
2. The overall trial end date was changed from 01/09/2022 to 01/01/2023.
08/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/03/2022 to 01/09/2022.
2. The overall trial end date was changed from 01/06/2022 to 01/09/2022.
3. The intention to publish date was changed from 01/06/2023 to 01/09/2023.
20/04/2022: The overall trial end date has been changed from 08/04/2022 to 01/06/2022 and the plain English summary has been updated accordingly.
04/02/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/01/2022 to 28/03/2022.
2. The overall trial end date has been changed from 01/02/2022 to 08/04/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/02/2023 to 01/06/2023.
11/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 01/01/2022.
2. The overall trial end date was changed from 01/10/2021 to 01/02/2022.
3. The intention to publish date was changed from 01/10/2022 to 01/02/2023.
11/06/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
