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Sickle Cell DiseasePhase 2TAPS2NCT03975894

TAPS2 Transfusion Antenatally in Pregnant Women With SCD

A Phase 2 study testing Serial prophylactic exchange blood transfusion (SPEBT). in people with Sickle Cell Disease and Pregnancy, High Risk, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Serial prophylactic exchange blood transfusion (SPEBT).
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesUnited Kingdom
Study dates
2 May 2019to 1 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

6 sites in 1 country.

Eugene Oteng-Ntim contact

+00 44 (0)2071886874

Eugene.Oteng-Ntim@gstt.nhs.uk

6 sites in 1 country

United Kingdom6 sites, 6 recruiting

  • Barts Health NHS Trust

    London

    Paul Telfer

    Not yet recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London

    Eugene Oteng-Ntim

    Recruiting

  • King's College Hospital

    London

    Jemma Johns

    Not yet recruiting

  • St George's University Hospitals NHS Foundation Trust

    London

    Ingrid Watt-Coote

    Not yet recruiting

  • Whittington Health NHS Trust

    London

    Emma Drasar

    Not yet recruiting

  • Manchester University NHS Foundation Trust

    Manchester

    Joseph Sharif

    Not yet recruiting

Other trials in United Kingdom

About this study

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

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.

Being tested
Serial prophylactic exchange blood transfusion (SPEBT).
Keywords
pregnancy, exchange transfusion, perinatal complications
Medical subject headings
Anemia, Sickle Cell, Transfusion Reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serial prophylactic exchange blood transfusion (SPEBT).Biological

    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.

Study groups in NCT03975894
Study groupRoleWhat they receive
InterventionExperimentalRegular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.
Receives: Biological: Serial prophylactic exchange blood transfusion (SPEBT).
ControlNo interventionSymptom directed blood transfusion during pregnancy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    ratio of women eligible:women randomised

    Measured: Baseline

Secondary outcomes (13)

  1. Feasibility endpoints

    Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence

    Measured: up to 6 weeks postpartum

  2. Maternal hospital admissions

    Antenatal and postnatal inpatient stays

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

  3. Frequency and severity of painful crisis

    self-reported symptoms (mild/moderate/severe/extremely severe) and use of opioid analgesics

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

  4. Mode of birth

    Measured: 40 weeks

  5. SCD-related complications

    E.g. acute chest syndrome, stroke, pre-eclampsia, venous thromboembolism.

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

  6. Fetal demise/stillbirth

    Measured: 40 weeks

  7. Infant birthweight

    Birthweight in grams

    Measured: 40 weeks

  8. Gestation at birth

    Gestation at birth in completed weeks and days

    Measured: 40 weeks

  9. Fetal condition at birth

    Apgar score at five minutes

    Measured: 40 weeks

  10. Neonatal intensive care unit/critical care admission

    Measured: 6 weeks postpartum

  11. Safety outcome 1: transfusion reaction

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

  12. Safety outcome 2: Alloimmunisation

    Irregular presence of red cell antibodies will be measured by routine blood test

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

  13. Safety outcome 3: Delayed haemolytic transfusion reaction

    After 7 days following transfusion:

    1. Fatigued, fever, jaundice, dark brown coca-cola urine B. Raised pulse, anaemia C. Dropping Haemoglobin, break down of haemoglobin, increased bilirubin

    Measured: Every 6-8 weeks from enrolment to 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2019
  2. Study start2 May 2019
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \<30%
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975894
Sponsor's protocol ID
TAPS2version3
Acronym
TAPS2
Status last verified
Jun 2019
First submitted
17 May 2019
Last updated
2 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38954844

  • 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.

    PubMed 32312326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serial prophylactic exchange blood transfusion (SPEBT). in people with Sickle Cell Disease and Pregnancy, High Risk, run by Guy's and St Thomas' NHS Foundation Trust at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eugene Oteng-Ntim (+00 44 (0)2071886874, Eugene.Oteng-Ntim@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03975894, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.

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