NCT03975894: TAPS2

TAPS2 Transfusion Antenatally in Pregnant Women With SCD

Status unknown Phase 2 Last updated 2 August 2019

What this trial tests

Phase 2 trial testing Serial prophylactic exchange blood transfusion (SPEBT). in Sickle Cell Disease in 50 participants. Status unknown.

Timeline

2 May 2019

Primary endpoint
1 December 2020

1 May 2021

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	2 May 2019
Primary completion	1 December 2020
Estimated completion	1 May 2021
Sites	6 locations across United Kingdom

Drugs / interventions tested

• Serial prophylactic exchange blood transfusion (SPEBT). — full drug profile →

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
• Blood Transfusion Complication — all drugs for Blood Transfusion Complication →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

18 and older, female only, with Sickle Cell Disease or Pregnancy, High Risk. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. It has been suggested that 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. A trial is needed to assess SPEBT given every 6-10 weeks, starting before 18 weeks of pregnancy, compared to standard care. This trial will evaluate outcomes for women (e.g. hospital admission, frequency of crisis) and their infants (e.g. early delivery, birthweight). However, the feasibility of such a study needs to be assessed before embarking on a large multicentre trial. This study is therefore 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. The willingness of eligible women to join the study will be assessed, along with how many participants remain part of the study until the end and if participants find the intervention acceptable.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Severe Maternal Morbidity and Mortality in Sickle Cell Disease in the National Inpatient Sample, 2012-2018.
   Early ML, Eke AC, Gemmill A, Lanzkron S, et al · · 2023 · cited 37× · PMID 36729452 · DOI 10.1001/jamanetworkopen.2022.54552
2. Managing sickle cell disease and related complications in pregnancy: results of an international Delphi panel.
   Sharma D, Kozanoğlu I, Ataga KI, Benachi A, et al · · 2024 · cited 16× · PMID 38206762 · DOI 10.1182/bloodadvances.2023011301
3. Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial.
   Oakley LL, Awogbade M, Brien S, Briley A, et al · · 2020 · cited 14× · PMID 32312326 · DOI 10.1186/s13063-020-4212-8
4. Prophylactic exchange transfusion in sickle cell disease pregnancy: a TAPS2 feasibility randomized controlled trial.
   Oteng-Ntim E, Oakley LL, Robinson V, Brien S, et al · · 2024 · cited 10× · PMID 38954844 · DOI 10.1182/bloodadvances.2024012923
5. Recommendations for Pregnancy in Rare Inherited Anemias.
   Taher AT, Iolascon A, Matar CF, Bou-Fakhredin R, et al · · 2020 · cited 10× · PMID 32885142 · DOI 10.1097/hs9.0000000000000446
6. Interventions for preventing silent cerebral infarcts in people with sickle cell disease.
   Estcourt LJ, Kimber C, Hopewell S, Trivella M, et al · · 2020 · cited 10× · PMID 32250453 · DOI 10.1002/14651858.cd012389.pub3
7. Evidence-based management of pregnant women with sickle cell disease in high-income countries.
   Oteng-Ntim E, Shangaris P. · · 2022 · cited 6× · PMID 36485166 · DOI 10.1182/hematology.2022000378
8. Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): statistical and qualitative analysis plan for a randomised controlled feasibility trial.
   Seed PT, Brien SB, Oakley LL, Robinson V, et al · · 2023 · cited 3× · PMID 36964626 · DOI 10.1186/s13063-023-07235-x