Cargando…

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 outs...

Descripción completa

Detalles Bibliográficos
Autores principales: Oakley, Laura L., 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, Oteng-Ntim, Eugene
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171865/
https://www.ncbi.nlm.nih.gov/pubmed/32312326
http://dx.doi.org/10.1186/s13063-020-4212-8
_version_ 1783524153619382272
author Oakley, Laura L.
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
Oteng-Ntim, Eugene
author_facet Oakley, Laura L.
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
Oteng-Ntim, Eugene
author_sort Oakley, Laura L.
collection PubMed
description 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).
format Online
Article
Text
id pubmed-7171865
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-71718652020-04-24 Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial Oakley, Laura L. 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 Oteng-Ntim, Eugene Trials Study Protocol 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). BioMed Central 2020-04-20 /pmc/articles/PMC7171865/ /pubmed/32312326 http://dx.doi.org/10.1186/s13063-020-4212-8 Text en © The Author(s). 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Oakley, Laura L.
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
Oteng-Ntim, Eugene
Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title_full Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title_fullStr Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title_full_unstemmed Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title_short Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
title_sort serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (taps-2): study protocol for a randomised controlled feasibility trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171865/
https://www.ncbi.nlm.nih.gov/pubmed/32312326
http://dx.doi.org/10.1186/s13063-020-4212-8
work_keys_str_mv AT oakleylaural serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT awogbademoji serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT briensarah serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT brileyannette serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT chorozogloumaria serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT drasaremma serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT johnsjemma serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT rhodeselizabeth serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT robinsonvicky serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT seedpaul serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT sharifjoseph serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT singhclaire serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT telferpaul serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT thompsonhilary serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT wattcooteingrid serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT howardjo serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial
AT otengntimeugene serialprophylacticexchangebloodtransfusioninpregnantwomenwithsicklecelldiseasetaps2studyprotocolforarandomisedcontrolledfeasibilitytrial