- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975894
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Eugene Oteng-Ntim
- Phone Number: +00 44 (0)2071886874
- Email: Eugene.Oteng-Ntim@gstt.nhs.uk
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
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London, United Kingdom
- Not yet recruiting
- St George's University Hospitals NHS Foundation Trust
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Contact:
- Ingrid Watt-Coote
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Eugene Oteng-Ntim, Guy's and St Thomas' NHS Foundation Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAPS2version3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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