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Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial

Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
Background: pregnancies in women with sickle cell disease (SCD) are associated with a higher risk of sickle and pregnancy complications. Limited options exist for treating SCD during pregnancy. Serial prophylactic exchange blood transfusion (SPEBT) has been shown to be effective in treating SCD outside pregnancy, but evidence is lacking regarding its use during pregnancy. The aim of this study is to assess the feasibility and acceptability of conducting a future phase 3 randomised controlled trial (RCT) to establish the clinical and cost effectiveness of SPEBT in pregnant women with SCD.

Methods: the study is an individually randomised, two-arm, feasibility trial with embedded qualitative and health economic studies. Fifty women, 18 years of age and older, with SCD and a singleton pregnancy at ≤ 18 weeks’ gestation will be recruited from six hospitals in England. Randomisation will be conducted using a secure online database and minimised by centre, SCD genotype and maternal age. Women allocated to the intervention arm will receive SPEBT commencing at ≤ 18 weeks’ gestation, performed using automated erythrocytapheresis every 6–10 weeks until the end of pregnancy, aiming to maintain HbS% or combined HbS/HbC% below 30%. Women in the standard care arm will only receive transfusion when clinically indicated. The primary outcome will be the recruitment rate. Additional endpoints include reasons for refusal to participate, attrition rate, protocol adherence, and maternal and neonatal outcomes. Women will be monitored throughout pregnancy to assess maternal, sickle, and foetal complications. Detailed information about adverse events (including hospital admission) and birth outcomes will be extracted from medical records and via interview at 6 weeks postpartum. An embedded qualitative study will consist of interviews with (a) 15–25 trial participants to assess experiences and acceptability, (b) 5–15 women who decline to participate to identify barriers to recruitment and (c) 15–20 clinical staff to explore fidelity and acceptability. A health economic study will inform a future cost effectiveness and cost-utility analysis.

Discussion: this feasibility study aims to rigorously evaluate SPEBT as a treatment for SCD in pregnancy and its impact on maternal and infant outcomes.

Trial registration: NIH registry (www.clinicaltrials.gov), registration number NCT03975894 (registered 05/06/19); ISRCTN (www.isrctn.com), registration number ISRCTN52684446 (retrospectively registered 02/08/19).
Blood transfusion, Economic evaluation, Feasibility, Pregnancy, Qualitative, Randomised controlled trial, Sickle cell disease
1745-6215
Oakley, Laura
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Awogbade, Moji
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Brien, Sarah
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Briley, Annette
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Chorozoglou, Maria
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Drasar, Emma
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Johns, Jemma
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Rhodes, Elizabeth
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Robinson, Vicky
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Seed, Paul
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Sharif, Joseph
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Singh, Claire
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Telfer, Paul
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Thompson, Hilary
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Watt-Coote, Ingrid
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Howard, Jo
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Oteng-Ntim, Eugene
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Oakley, Laura
a10a8645-fa7b-4cf9-8177-accd5ff00a49
Awogbade, Moji
4d4efdbf-d6e3-49bb-855c-6b813e7bf922
Brien, Sarah
4e8e97cd-7bc3-4efd-857e-20790040b80f
Briley, Annette
abca087f-6908-4f83-96aa-ca2e39738427
Chorozoglou, Maria
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Drasar, Emma
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Johns, Jemma
e0a360ec-b270-478d-a3d3-4029d5664545
Rhodes, Elizabeth
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Robinson, Vicky
0023fa1f-8289-4179-b43e-a1a414d787ee
Seed, Paul
8bea9a5e-d374-4946-8616-07781e28c566
Sharif, Joseph
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Singh, Claire
2a95474f-ef83-4900-9e87-5b1bbbb32dc3
Telfer, Paul
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Thompson, Hilary
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Watt-Coote, Ingrid
cb892cd5-be63-407c-b40e-02f9da591dcb
Howard, Jo
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Oteng-Ntim, Eugene
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Oakley, Laura, Awogbade, Moji, Brien, Sarah, Briley, Annette, Chorozoglou, Maria, Drasar, Emma, Johns, Jemma, Rhodes, Elizabeth, Robinson, Vicky, Seed, Paul, Sharif, Joseph, Singh, Claire, Telfer, Paul, Thompson, Hilary, Watt-Coote, Ingrid, Howard, Jo and Oteng-Ntim, Eugene (2020) Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial. Trials, 21 (1), [347]. (doi:10.1186/s13063-020-4212-8).

Record type: Article

Abstract

Background: pregnancies in women with sickle cell disease (SCD) are associated with a higher risk of sickle and pregnancy complications. Limited options exist for treating SCD during pregnancy. Serial prophylactic exchange blood transfusion (SPEBT) has been shown to be effective in treating SCD outside pregnancy, but evidence is lacking regarding its use during pregnancy. The aim of this study is to assess the feasibility and acceptability of conducting a future phase 3 randomised controlled trial (RCT) to establish the clinical and cost effectiveness of SPEBT in pregnant women with SCD.

Methods: the study is an individually randomised, two-arm, feasibility trial with embedded qualitative and health economic studies. Fifty women, 18 years of age and older, with SCD and a singleton pregnancy at ≤ 18 weeks’ gestation will be recruited from six hospitals in England. Randomisation will be conducted using a secure online database and minimised by centre, SCD genotype and maternal age. Women allocated to the intervention arm will receive SPEBT commencing at ≤ 18 weeks’ gestation, performed using automated erythrocytapheresis every 6–10 weeks until the end of pregnancy, aiming to maintain HbS% or combined HbS/HbC% below 30%. Women in the standard care arm will only receive transfusion when clinically indicated. The primary outcome will be the recruitment rate. Additional endpoints include reasons for refusal to participate, attrition rate, protocol adherence, and maternal and neonatal outcomes. Women will be monitored throughout pregnancy to assess maternal, sickle, and foetal complications. Detailed information about adverse events (including hospital admission) and birth outcomes will be extracted from medical records and via interview at 6 weeks postpartum. An embedded qualitative study will consist of interviews with (a) 15–25 trial participants to assess experiences and acceptability, (b) 5–15 women who decline to participate to identify barriers to recruitment and (c) 15–20 clinical staff to explore fidelity and acceptability. A health economic study will inform a future cost effectiveness and cost-utility analysis.

Discussion: this feasibility study aims to rigorously evaluate SPEBT as a treatment for SCD in pregnancy and its impact on maternal and infant outcomes.

Trial registration: NIH registry (www.clinicaltrials.gov), registration number NCT03975894 (registered 05/06/19); ISRCTN (www.isrctn.com), registration number ISRCTN52684446 (retrospectively registered 02/08/19).

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e-pub ahead of print date: 20 April 2020
Published date: 20 April 2020
Keywords: Blood transfusion, Economic evaluation, Feasibility, Pregnancy, Qualitative, Randomised controlled trial, Sickle cell disease

Identifiers

Local EPrints ID: 439816
URI: http://eprints.soton.ac.uk/id/eprint/439816
ISSN: 1745-6215
PURE UUID: 5e17cd19-9362-4688-b77f-2ea927186f12
ORCID for Sarah Brien: ORCID iD orcid.org/0000-0003-1120-2364
ORCID for Maria Chorozoglou: ORCID iD orcid.org/0000-0001-5070-4653

Catalogue record

Date deposited: 05 May 2020 16:30
Last modified: 11 Oct 2022 01:42

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Contributors

Author: Laura Oakley
Author: Moji Awogbade
Author: Sarah Brien ORCID iD
Author: Annette Briley
Author: Emma Drasar
Author: Jemma Johns
Author: Elizabeth Rhodes
Author: Vicky Robinson
Author: Paul Seed
Author: Joseph Sharif
Author: Claire Singh
Author: Paul Telfer
Author: Hilary Thompson
Author: Ingrid Watt-Coote
Author: Jo Howard
Author: Eugene Oteng-Ntim

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