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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • London, United Kingdom
        • Not yet recruiting
        • King's College Hospital
        • Contact:
          • Jemma Johns
      • London, United Kingdom
        • Recruiting
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Eugene Oteng-Ntim
      • London, United Kingdom
        • Not yet recruiting
        • Barts Health NHS Trust
        • Contact:
          • Paul Telfer
      • London, United Kingdom
        • Not yet recruiting
        • St George's University Hospitals NHS Foundation Trust
        • Contact:
          • Ingrid Watt-Coote
      • London, United Kingdom
        • Not yet recruiting
        • Whittington Health NHS Trust
        • Contact:
          • Emma Drasar
      • Manchester, United Kingdom
        • Not yet recruiting
        • Manchester University NHS Foundation trust
        • Contact:
          • Joseph Sharif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.

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.

NO_INTERVENTION: Control
Symptom directed blood transfusion during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline
ratio of women eligible:women randomised
Baseline

Secondary Outcome Measures

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

Every 6-8 weeks from enrolment to 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (ACTUAL)

June 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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