TAPS2 Transfusion Antenatally in Pregnant Women With SCD
TAPS2
A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnant Women With Sickle Cell Disease Aiming to Improve Maternal and Infant Outcomes
1 other identifier
interventional
50
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2019
CompletedFirst Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 2, 2019
June 1, 2019
1.6 years
May 17, 2019
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment rate
ratio of women eligible:women randomised
Baseline
Secondary Outcomes (13)
Feasibility endpoints
up to 6 weeks postpartum
Maternal hospital admissions
Every 6-8 weeks from enrolment to 6 weeks postpartum
Frequency and severity of painful crisis
Every 6-8 weeks from enrolment to 6 weeks postpartum
Mode of birth
40 weeks
SCD-related complications
Every 6-8 weeks from enrolment to 6 weeks postpartum
- +8 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALRegular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \<30%.
Control
NO INTERVENTIONSymptom directed blood transfusion during pregnancy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pregnant women with sickle cell disease (all genotypes)
- Gestation 18+0 weeks or below
- Willing and able to give informed consent
- Singleton pregnancy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- King's College Hospital NHS Trustcollaborator
- Barts & The London NHS Trustcollaborator
- The Whittington Hospital NHS Trustcollaborator
- St Mary's NHS Trustcollaborator
- University College London Hospitalscollaborator
- St George's University Hospitals NHS Foundation Trustcollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- King's College Londoncollaborator
- University of Southamptoncollaborator
Study Sites (6)
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, United Kingdom
Related Publications (2)
Oteng-Ntim E, Oakley LL, Robinson V, Brien S, Joseph J, Sharif J, McCabe L, Thompson H, Awogbade M, Johns J, Brunetta DM, Seed PT. Prophylactic exchange transfusion in sickle cell disease pregnancy: a TAPS2 feasibility randomized controlled trial. Blood Adv. 2024 Aug 27;8(16):4359-4369. doi: 10.1182/bloodadvances.2024012923.
PMID: 38954844DERIVEDOakley 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.
PMID: 32312326DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene Oteng-Ntim
Guy's and St Thomas' NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2019
First Posted
June 5, 2019
Study Start
May 2, 2019
Primary Completion
December 1, 2020
Study Completion
May 1, 2021
Last Updated
August 2, 2019
Record last verified: 2019-06