TAPS2 Transfusion Antenatally in Pregnant Women With SCD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2021-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Sickle Cell Disease Pregnancy, High Risk Blood Transfusion Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Serial prophylactic exchange blood transfusion (SPEBT).

Intervention Type BIOLOGICAL

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.

Control

Symptom directed blood transfusion during pregnancy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugene Oteng-Ntim

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

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