TAPS2 Transfusion Antenatally in Pregnant Women With SCD

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Unknown; Phase 2

Conditions: Blood Transfusion Complication; Sickle Cell Disease; Pregnancy, High Risk

Treatments: Biological: Serial prophylactic exchange blood transfusion (SPEBT).

Study type: Interventional

Funder types: Other

Identifiers

NCT03975894

TAPS2version3

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women with sickle cell disease (all genotypes)
• Gestation 18+0 weeks or below
• Willing and able to give informed consent
• Singleton pregnancy

Exclusion criteria

• On long term transfusion programme prior to pregnancy for amelioration of SCD
• Prior Hyperhaemolysis
• Red cell phenotype or antibodies present prevent likely provision of adequate red cell units to support elective EBT programme
• Unable to receive blood transfusion for social, religious or clinical reasons
• Current diagnosis of major medical or psychiatric comorbidity which in the randomising clinicians opinion renders them unable to enter trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Intervention

Experimental group

Description:

Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \<30%.

Treatment:

Biological: Serial prophylactic exchange blood transfusion (SPEBT).

Control

No Intervention group

Description:

Symptom directed blood transfusion during pregnancy.