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TAPS2 Transfusion Antenatally in Pregnant Women With SCD (TAPS2)

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ClinicalTrials.gov Identifier: NCT03975894
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
King's College Hospital NHS Trust
Barts & The London NHS Trust
The Whittington Hospital NHS Trust
St Mary's NHS Trust
University College London Hospitals
St George's University Hospitals NHS Foundation Trust
London School of Hygiene and Tropical Medicine
King's College London
University of Southampton
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date August 2, 2019
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
Recruitment rate [ Time Frame: Baseline ]
ratio of women eligible:women randomised
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03975894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Feasibility endpoints [ Time Frame: up to 6 weeks postpartum ]
    Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence
  • Maternal hospital admissions [ Time Frame: Every 6-8 weeks from enrolment to 6 weeks postpartum ]
    Antenatal and postnatal inpatient stays
  • 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
  • Mode of birth [ Time Frame: 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.
  • Fetal demise/stillbirth [ Time Frame: 40 weeks ]
  • Infant birthweight [ Time Frame: 40 weeks ]
    Birthweight in grams
  • Gestation at birth [ Time Frame: 40 weeks ]
    Gestation at birth in completed weeks and days
  • Fetal condition at birth [ Time Frame: 40 weeks ]
    Apgar score at five minutes
  • Neonatal intensive care unit/critical care admission [ Time Frame: 6 weeks postpartum ]
  • Safety outcome 1: transfusion reaction [ Time Frame: 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Feasibility endpoints [ Time Frame: up to 6 weeks postpartum ]
    Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence
  • Maternal hospital admissions [ Time Frame: Every 6-8 weeks from enrolment to 6 weeks postpartum ]
    Antenatal and postnatal inpatient stays
  • 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
  • Mode of birth [ Time Frame: 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.
  • Fetal demise/stillbirth [ Time Frame: 40 weeks ]
  • Infant birthweight [ Time Frame: 40 weeks ]
    Birthweight in grams
  • Gestation at birth [ Time Frame: 40 weeks ]
    Gestation at birth in completed weeks and days
  • Fetal condition at birth [ Time Frame: 40 weeks ]
    Apgar score at five minutes
  • Neonatal intensive care unit/critical care admission [ Time Frame: 6 weeks postpartum ]
  • Safety outcome 1: transfusion reaction [ Time Frame: 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
  • Safety outcome 3: Delayed haemolytic transfusion reaction [ Time Frame: Every 6-8 weeks from enrolment to 6 weeks postpartum ]
    Assessed by clinical diagnosis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TAPS2 Transfusion Antenatally in Pregnant Women With SCD
Official Title  ICMJE A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnant Women With Sickle Cell Disease Aiming to Improve Maternal and Infant Outcomes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Pregnancy, High Risk
  • Blood Transfusion Complication
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: Intervention
    Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.
    Intervention: Biological: Serial prophylactic exchange blood transfusion (SPEBT).
  • No Intervention: Control
    Symptom directed blood transfusion during pregnancy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eugene Oteng-Ntim +00 44 (0)2071886874 Eugene.Oteng-Ntim@gstt.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975894
Other Study ID Numbers  ICMJE TAPS2version3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Guy's and St Thomas' NHS Foundation Trust
Collaborators  ICMJE
  • King's College Hospital NHS Trust
  • Barts & The London NHS Trust
  • The Whittington Hospital NHS Trust
  • St Mary's NHS Trust
  • University College London Hospitals
  • St George's University Hospitals NHS Foundation Trust
  • London School of Hygiene and Tropical Medicine
  • King's College London
  • University of Southampton
Investigators  ICMJE
Principal Investigator: Eugene Oteng-Ntim Guy's and St Thomas' NHS Foundation Trust
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP