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TAPS2 Transfusion Antenatally in Pregnant Women With SCD (TAPS2)

Primary Purpose

Sickle Cell Disease, Pregnancy, High Risk, Blood Transfusion Complication

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Serial prophylactic exchange blood transfusion (SPEBT).
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring pregnancy, exchange transfusion, perinatal complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Barts Health NHS Trust
  • Guy's and St Thomas' NHS Foundation TrustRecruiting
  • King's College Hospital
  • St George's University Hospitals NHS Foundation Trust
  • Whittington Health NHS Trust
  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.

Symptom directed blood transfusion during pregnancy.

Outcomes

Primary Outcome Measures

Recruitment rate
ratio of women eligible:women randomised

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2019
Last Updated
August 1, 2019
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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
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1. Study Identification

Unique Protocol Identification Number
NCT03975894
Brief Title
TAPS2 Transfusion Antenatally in Pregnant Women With SCD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Pregnancy, High Risk, Blood Transfusion Complication
Keywords
pregnancy, exchange transfusion, perinatal complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Symptom directed blood transfusion during pregnancy.
Intervention Type
Biological
Intervention Name(s)
Serial prophylactic exchange blood transfusion (SPEBT).
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
ratio of women eligible:women randomised
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Feasibility endpoints
Description
Number of women eligible, reasons for refusal, rate and reasons for attrition, protocol adherence
Time Frame
up to 6 weeks postpartum
Title
Maternal hospital admissions
Description
Antenatal and postnatal inpatient stays
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum
Title
Frequency and severity of painful crisis
Description
self-reported symptoms (mild/moderate/severe/extremely severe) and use of opioid analgesics
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum
Title
Mode of birth
Time Frame
40 weeks
Title
SCD-related complications
Description
E.g. acute chest syndrome, stroke, pre-eclampsia, venous thromboembolism.
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum
Title
Fetal demise/stillbirth
Time Frame
40 weeks
Title
Infant birthweight
Description
Birthweight in grams
Time Frame
40 weeks
Title
Gestation at birth
Description
Gestation at birth in completed weeks and days
Time Frame
40 weeks
Title
Fetal condition at birth
Description
Apgar score at five minutes
Time Frame
40 weeks
Title
Neonatal intensive care unit/critical care admission
Time Frame
6 weeks postpartum
Title
Safety outcome 1: transfusion reaction
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum
Title
Safety outcome 2: Alloimmunisation
Description
Irregular presence of red cell antibodies will be measured by routine blood test
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum
Title
Safety outcome 3: Delayed haemolytic transfusion reaction
Description
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
Time Frame
Every 6-8 weeks from enrolment to 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Oteng-Ntim
Phone
+00 44 (0)2071886874
Email
Eugene.Oteng-Ntim@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Oteng-Ntim
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Telfer
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Oteng-Ntim
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jemma Johns
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingrid Watt-Coote
Facility Name
Whittington Health NHS Trust
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Drasar
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Sharif

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32312326
Citation
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.
Results Reference
derived

Learn more about this trial

TAPS2 Transfusion Antenatally in Pregnant Women With SCD

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