Clinical trial NCT03975894: TAPS2 Transfusion Antenatally in Pregnant Women With SCD
Official title: A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnant Women With Sickle Cell Disease Aiming to Improve Maternal and Infant Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sickle Cell Disease
Pregnancy, High Risk
Blood Transfusion Complication
Keywords: pregnancy
exchange transfusion
perinatal complications
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
name: Barts & The London NHS Trust
name: The Whittington Hospital NHS Trust
name: St Mary's NHS Trust
name: University College London Hospitals
name: St George's University Hospitals NHS Foundation Trust
name: London School of Hygiene and Tropical Medicine
name: King's College London
name: University of Southampton
First posted: 2019-06-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \<30%
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
Secondary outcomes:
measure: Feasibility endpoints
timeFrame: up to 6 weeks postpartum
measure: Maternal hospital admissions
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
measure: Frequency and severity of painful crisis
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
measure: Mode of birth
timeFrame: 40 weeks
measure: SCD-related complications
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
measure: Fetal demise/stillbirth
timeFrame: 40 weeks
measure: Infant birthweight
timeFrame: 40 weeks
measure: Gestation at birth
timeFrame: 40 weeks
measure: Fetal condition at birth
timeFrame: 40 weeks
measure: Neonatal intensive care unit/critical care admission
timeFrame: 6 weeks postpartum
measure: Safety outcome 1: transfusion reaction
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
measure: Safety outcome 2: Alloimmunisation
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
measure: Safety outcome 3: Delayed haemolytic transfusion reaction
timeFrame: Every 6-8 weeks from enrolment to 6 weeks postpartum
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Whittington Health NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Eugene Oteng-Ntim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oakley LL, Awogbade M, Brien S, Briley A, Chorozoglou M, Drasar E, Johns J, Rhodes E, Robinson V, Seed P, Sharif J, Singh C, Telfer P, Thompson H, Watt-Coote I, Howard J, Oteng-Ntim E. Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial. Trials. 2020 Apr 20;21(1):347. doi: 10.1186/s13063-020-4212-8.