TAPS2: Transfusions Antenatally in Pregnant women with SCD
Research type
Research Study
Full title
A feasibility trial of serial prophylactic exchange blood transfusion (SPEBT) in pregnant women with sickle cell disease (SCD) aiming to improve maternal and infant outcomes
IRAS ID
246179
Contact name
Eugene Oteng-Ntim
Contact email
Sponsor organisation
Guy’s and St Thomas NHS Foundation Trust
ISRCTN Number
ISRCTN52684446
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Sickle Cell Disease (SCD) is a serious inherited blood disorder affecting red blood cells. When oxygen levels drop the red cells become abnormally shaped and unable to move through the blood vessels easily. Blood and oxygen do not reach body organs, resulting in episodes of severe pain and other complications. Pregnant women with SCD have an increased risk of both sickle and pregnancy complications, including raised blood pressure. Their babies may grow more slowly in the womb, are more likely to be born early and need special care, and have a higher risk of dying. The only treatments currently available for women with SCD are Hydroxycarbamide (which cannot be used during pregnancy) and blood transfusion. Currently, blood transfusion is only used during pregnancy to treat emergency complications. We believe giving blood transfusions throughout pregnancy could improve outcomes for both mother and babies. In Serial Prophylactic Exchange Blood Transfusion (SPEBT), sickle blood is mechanically removed and simultaneously replaced with donor red cells. We wish to conduct a trial of SPEBT given every 6-8 weeks, starting before 18 weeks of pregnancy, compared to standard care. We will measure outcomes in the woman (e.g. hospital admission, frequency of crisis) and their infants (e.g. early delivery, birthweight). Before we embark on a large multi-centre study we need to know if this is feasible. We will therefore undertake a feasibility study in which we will randomly allocate participants to have either SPEBT or standard care. The study will be carried out in multiple maternity units in England and last two years. We will assess how many pregnant women are willing to join the study and how many participants remain part of the study until the end and if participants find the intervention acceptable.
Lay Summary of Results
Aim: Would pregnant women with sickle cell disease (SCD) say yes to being in research (TAPS2) looking at having
regular blood transfusions to maintain health. There is a lack of evidence about this treatment in pregnancy.
Background: SCD is an inherited condition affecting red blood cells (RBC) causing blockages in blood vessels,
leading to serious health problems, sometimes worse in pregnancy. Blood transfusion removing these RBC and
replacing with healthy ones can help maintain health. To check if pregnant women with SCD would choose to be in a
study that randomly put them one of two groups (one group, the 'treatment' group- had these transfusions and the
other group has normal care) we ran a smaller trial first, called TAPS2, and also interviewed women and staff about
what they thought of the study.
Study design and findings: We asked pregnant women with SCD to be in TAPS2, then recorded who said yes, no
or those unable to participate and why. For those in TAPS2, we recorded who had transfusions, how many and who
stayed in the trial until the end. This would show if a larger trial comparing the 2 groups could be successful. We
found women were willing to take part, receive the treatment and complete the trial. These findings show a larger
trial is possible to compare regular transfusions with normal care to see if this helps pregnant women with SCD and
their babies to be healthier.
Patient and public involvement: People with SCD helped design the trial, attended meetings and shared their
personal experiences. They assisted with the research website and discussed the trial with women who had SCD.
SCD support organisations advertised the trial.
Dissemination: Results will be published in medical journals, shared with SCD support groups and presented at
conferences in the UK and abroad.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN52684446%2FNBTI%2FMV64AQ%2FAQ%2Fceca035e-4ecd-49fe-9c5f-f8b41f7274bc%2F1%2Fn6HCkSOBxy&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C02b6ed7009094febc66d08dce1625dc3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638633059792470581%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=uMIR7gIfGl8M7cLi7KgCqsplsLlBxI2u7zmNuevAGd8%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: TAPS2 Protocol: -
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F32312326%252F%2FNBTI%2FMV64AQ%2FAQ%2Fceca035e-4ecd-49fe-9c5f-f8b41f7274bc%2F2%2Fbb9ZMMmTYJ&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C02b6ed7009094febc66d08dce1625dc3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638633059792500271%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=qJFMbho497%2Bmb3QNPlO3GCDbtozAqf3r2FCkG8iSFnM%3D&reserved=0TAPS2 Statistical Analysis Plan:-
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F36964626%252F%2FNBTI%2FMV64AQ%2FAQ%2Fceca035e-4ecd-49fe-9c5f-f8b41f7274bc%2F3%2FO6gMkUcB6f&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C02b6ed7009094febc66d08dce1625dc3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638633059792514425%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=IsvPmqaaFBIGt4TT5kfG9dzGLmYvK2D8VvED4wTKR9k%3D&reserved=0TAPS2 results:-
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38954844%252F%2FNBTI%2FMV64AQ%2FAQ%2Fceca035e-4ecd-49fe-9c5f-f8b41f7274bc%2F4%2FXUUNalmGbW&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C02b6ed7009094febc66d08dce1625dc3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638633059792526553%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=XK5sHJKe3YxnNhkycMDdNYOfmVIkL2JAXkMZfdzwz9w%3D&reserved=0If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 30/11/2024
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Results published here:-https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.guysandstthomas.nhs.uk%2Fnews%2Ffirst-trial-its-kind-pregnant-women-sickle-cell-disease&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C02b6ed7009094febc66d08dce1625dc3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638633059792542870%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lUV5l82FGxg0LBEZh6uytRIKRve8ybkjkWZhwgnTU%2Fg%3D&reserved=0
If no, explain why sharing hasn't been enabled: In discussion with stakeholders to share to interested parties on relevant websites.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No samples taken.REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/2070
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion