TAPS2 Transfusion Antenatally in Pregnant Women With SCD (TAPS2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03975894 |
Recruitment Status : Unknown
Verified June 2019 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : June 5, 2019
Last Update Posted : August 2, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease Pregnancy, High Risk Blood Transfusion Complication | Biological: Serial prophylactic exchange blood transfusion (SPEBT). | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
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 |
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 |
Actual Study Start Date : | May 2, 2019 |
Estimated Primary Completion Date : | December 1, 2020 |
Estimated Study Completion Date : | May 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of <30%.
|
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. |
No Intervention: Control
Symptom directed blood transfusion during pregnancy.
|
- Recruitment rate [ Time Frame: Baseline ]ratio of women eligible:women randomised
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975894
Contact: Eugene Oteng-Ntim | +00 44 (0)2071886874 | Eugene.Oteng-Ntim@gstt.nhs.uk |
United Kingdom | |
Barts Health NHS Trust | Not yet recruiting |
London, United Kingdom | |
Contact: Paul Telfer | |
Guy's and St Thomas' NHS Foundation Trust | Recruiting |
London, United Kingdom | |
Contact: Eugene Oteng-Ntim | |
King's College Hospital | Not yet recruiting |
London, United Kingdom | |
Contact: Jemma Johns | |
St George's University Hospitals NHS Foundation Trust | Not yet recruiting |
London, United Kingdom | |
Contact: Ingrid Watt-Coote | |
Whittington Health NHS Trust | Not yet recruiting |
London, United Kingdom | |
Contact: Emma Drasar | |
Manchester University NHS Foundation Trust | Not yet recruiting |
Manchester, United Kingdom | |
Contact: Joseph Sharif |
Principal Investigator: | Eugene Oteng-Ntim | Guy's and St Thomas' NHS Foundation Trust |
Responsible Party: | Guy's and St Thomas' NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT03975894 |
Other Study ID Numbers: |
TAPS2version3 |
First Posted: | June 5, 2019 Key Record Dates |
Last Update Posted: | August 2, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pregnancy exchange transfusion perinatal complications |
Anemia, Sickle Cell Transfusion Reaction Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Immune System Diseases |