TAPS2 Transfusion Antenatally in Pregnant Women With SCD

Sickle Cell Disease Clinical Trial

— TAPS2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03975894
• Other study ID #: TAPS2version3
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Eugene Oteng-Ntim
• Phone: +00 44 (0)2071886874
• Email: Eugene.Oteng-Ntim[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
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	Manchester University NHS Foundation Trust	Manchester

Sponsors (10)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Barts & The London NHS Trust, King's College Hospital NHS Trust, King's College London, London School of Hygiene and Tropical Medicine, St George's University Hospitals NHS Foundation Trust, St Mary's NHS Trust, The Whittington Hospital NHS Trust, University College London Hospitals, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	ratio of women eligible:women randomised	Baseline
Secondary	Feasibility endpoints	Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence	up to 6 weeks postpartum
Secondary	Maternal hospital admissions	Antenatal and postnatal inpatient stays	Every 6-8 weeks from enrolment to 6 weeks postpartum
Secondary	Frequency and severity of painful crisis	self-reported symptoms (mild/moderate/severe/extremely severe) and use of opioid analgesics	Every 6-8 weeks from enrolment to 6 weeks postpartum
Secondary	Mode of birth		40 weeks
Secondary	SCD-related complications	E.g. acute chest syndrome, stroke, pre-eclampsia, venous thromboembolism.	Every 6-8 weeks from enrolment to 6 weeks postpartum
Secondary	Fetal demise/stillbirth		40 weeks
Secondary	Infant birthweight	Birthweight in grams	40 weeks
Secondary	Gestation at birth	Gestation at birth in completed weeks and days	40 weeks
Secondary	Fetal condition at birth	Apgar score at five minutes	40 weeks
Secondary	Neonatal intensive care unit/critical care admission		6 weeks postpartum
Secondary	Safety outcome 1: transfusion reaction		Every 6-8 weeks from enrolment to 6 weeks postpartum
Secondary	Safety outcome 2: Alloimmunisation	Irregular presence of red cell antibodies will be measured by routine blood test	Every 6-8 weeks from enrolment to 6 weeks postpartum
Secondary	Safety outcome 3: Delayed haemolytic transfusion reaction	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 bilirubin	Every 6-8 weeks from enrolment to 6 weeks postpartum