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出境医 / 临床实验 / TAPS2 Transfusion Antenatally in Pregnant Women With SCD (TAPS2)
TAPS2 Transfusion Antenatally in Pregnant Women With SCD (TAPS2)
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.
| 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 Design
| 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 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- Recruitment rate [ Time Frame: Baseline ]ratio of women eligible:women randomised
Secondary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Eugene Oteng-Ntim | +00 44 (0)2071886874 | Eugene.Oteng-Ntim@gstt.nhs.uk |
Locations
| 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 | |
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
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
| Principal Investigator: | Eugene Oteng-Ntim | 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 |
Recruitment rate [ Time Frame: Baseline ] ratio of women eligible:women randomised
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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 |
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| Condition ICMJE |
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| 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. |
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| Study Arms ICMJE |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Guy's and St Thomas' NHS Foundation Trust | ||||
| Study Sponsor ICMJE | Guy's and St Thomas' NHS Foundation Trust | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Guy's and St Thomas' NHS Foundation Trust | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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