TAPS2 Transfusion Antenatally in Pregnant Women With SCD
- Conditions
- Blood Transfusion ComplicationSickle Cell DiseasePregnancy, High Risk
- Interventions
- Biological: Serial prophylactic exchange blood transfusion (SPEBT).
- Registration Number
- NCT03975894
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- Pregnant women with sickle cell disease (all genotypes)
- Gestation 18+0 weeks or below
- Willing and able to give informed consent
- Singleton pregnancy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Serial prophylactic exchange blood transfusion (SPEBT). Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \<30%.
- Primary Outcome Measures
Name Time Method Recruitment rate Baseline ratio of women eligible:women randomised
- Secondary Outcome Measures
Name Time Method Gestation at birth 40 weeks Gestation at birth in completed weeks and days
Safety outcome 2: Alloimmunisation Every 6-8 weeks from enrolment to 6 weeks postpartum Irregular presence of red cell antibodies will be measured by routine blood test
Mode of birth 40 weeks SCD-related complications Every 6-8 weeks from enrolment to 6 weeks postpartum E.g. acute chest syndrome, stroke, pre-eclampsia, venous thromboembolism.
Safety outcome 1: transfusion reaction Every 6-8 weeks from enrolment to 6 weeks postpartum Feasibility endpoints up to 6 weeks postpartum Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence
Neonatal intensive care unit/critical care admission 6 weeks postpartum Maternal hospital admissions Every 6-8 weeks from enrolment to 6 weeks postpartum Antenatal and postnatal inpatient stays
Infant birthweight 40 weeks Birthweight in grams
Fetal condition at birth 40 weeks Apgar score at five minutes
Safety outcome 3: Delayed haemolytic transfusion reaction Every 6-8 weeks from enrolment to 6 weeks postpartum After 7 days following transfusion:
A. Fatigued, fever, jaundice, dark brown coca-cola urine B. Raised pulse, anaemia C. Dropping Haemoglobin, break down of haemoglobin, increased bilirubinFrequency and severity of painful crisis Every 6-8 weeks from enrolment to 6 weeks postpartum self-reported symptoms (mild/moderate/severe/extremely severe) and use of opioid analgesics
Fetal demise/stillbirth 40 weeks
Trial Locations
- Locations (6)
Barts Health NHS Trust
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
St George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Whittington Health NHS Trust
🇬🇧London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom