TAPS2 Transfusion Antenatally in Pregnant Women With SCD

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. 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.

Conditions

• Sickle Cell Disease
• Pregnancy, High Risk
• Blood Transfusion Complication

Interventions

BIOLOGICAL

Serial prophylactic exchange blood transfusion (SPEBT).

Serial prophylactic exchange blood transfusion (SPEBT) will be given via automated apheresis technology. SPEBT will be carried out on the haematology day unit or on the antenatal day unit/ward in accordance with local policies in participating units. The procedure will be carried out using standard operating procedures, by the clinical or research nurse/midwife, haematology day unit staff or specialist sickle nursing staff. Venous access will be via peripheral access if possible or by femoral line access if not. SPEBT will be commenced between 6 and 18+0 weeks gestation. It will be repeated at 6-10 weekly intervals aiming to maintain HbS% \<30%. It will continue throughout pregnancy and be stopped at the end of pregnancy. Number of red cell units used per transfusion will depend on patient weight and pre-transfusion HbS%, but will usually be between 6 and 8 units of red cells on each occasion of exchange transfusion.

Sponsors & Collaborators

• King's College Hospital NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• The Whittington Hospital NHS Trust

  collaborator OTHER_GOV

• St Mary's NHS Trust

  collaborator OTHER_GOV

• University College London Hospitals

  collaborator OTHER

• St George's University Hospitals NHS Foundation Trust

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Eugene Oteng-Ntim · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-02

Primary Completion

2020-12-01

Completion

2021-05-01

Countries

• United Kingdom

Study Locations