Annual Review 2018 - 2019 · 2019-06-07 · Social Media / Websites NHSBT CTU Team and Contacts. Foreword ... stem cell transplant. It compared only giving platelet transfusions when

Annual Review 2018 - 2019

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ForewordOur Year in ReviewPublication HighlightsNHSBT Patient and Public Advisory GroupA "TOPPS" SuccessSupporting World Kidney DayConference AttendanceInternational Clinical Trials DayLooking AheadSocial Media / WebsitesNHSBT CTU Team and Contacts

Foreword

Director of NHSBT Clinical Trials Unit,and Consultant Haematologist  (NHSBT) /Senior Clinical Lecturer (University of Oxford)

Dr Lise Estcourt

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Research is essential if we are going to provide the best care forpatients, donors, and their families. This report highlights some ofthe impact we have had in 2018 and we plan to build on this greatwork in 2019/20. Our expanding Clinical Trials Unit is providingsupport for research in blood transfusion and organ transplantation,with the use of complex trial designs (PITHIA),  large multi-nationalrandomised controlled trials (TREATT) and large NIHR-funded trials(CRYOSTAT-2 and SONAR). Our work has changed transfusionpractice (TOPPS) and highlighted that premature babies may beharmed by platelet transfusions (PlaNeT-2). We are activelyinvolving patients and the public in our work, and they will help toguide our future priorities.

Our year in review  ...

31 TEAM MEMBERS(4 NEW MEMBERS INTHE LAST YEAR) NEW

PUBLICATIONS

£1.9m GRANTFUNDING

AWARDED

9 ACTIVE CLINICAL TRIALS, INVOLVING

161 HOSPITAL TEAMS ACROSS THE UK, AS

WELL AS IN IRELAND, THE NETHERLANDS,

NEW ZEALAND AND AUSTRALIA!

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779 PARTICIPANTS HAVE TAKENPART IN ONE OF OUR CLINICAL

TRIALS

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Publication  Highlights...

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Curley A,  Stanworth S, Willoughby K, Fustolo Gunnink S, Venkatesh V, Hudson C,Deary A, Hodge R, Hopkins V, Lopez Santamaria B, Mora A, Llewelyn C, D’Amore A,Khan R, Onland W, Lopriore E, Fijnvandraat K, New H, Clarke P and Watts T for thePlaNeT-2 – MATISSE collaborators. Randomized Trial of Platelet-TransfusionThresholds in Neonates (PlaNeT-2). New England Journal of Medicine 2019;380:242-251 DOI: 10.1056/NEJMoa1807320 Curry N, Foley C, Wong H, Mora A, Curnow E, Zarankaite A, Hodge R, Hopkins V,Deary A, Ray J, Moss P, Reed M, Kellett S, Davenport R and Stanworth S.  EarlyFibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): resultsfrom a UK multicentre, randomised, double blind, placebo controlled trial. CriticalCare (2018) June: 22:164 Stanworth S, Desborough M, Simons G, Seeney F, Powter G, MacDonald S, McKechnieS, Green L, Young N, Walsh T and Laffan M. Clinical bleeding and thrombin generationin admissions to critical care with prolonged prothrombin time: an exploratory study(ISOC-2). Transfusion (2018) Vol 58 June pp1388 -98 Marsden M, Benger J, Brohi K, Curry N, Foley C, Green L,  Lucas J, Rossetto A,Stanworth S, Thomas H, Davenport R  on behalf of the CRYOSTAT-2 investigators.Coagulopathy, cryoprecipitate and CRYOSTAT-2: realising the potential of anationwide trauma system for a national clinical trial. British Journal of Anaesthesia(2018) DOI:10.1016/j.bja.2018.10.055 Ayorinde J, Summers D, Pankhurst L, Laing E, Deary A, Hemming K, Wilson E, BardsleyV, Neil D, Pettigrew G. Pre-Implantation Trial of Histopathology In renal Allografts(PITHIA): a stepped-wedge cluster randomised controlled trial protocol. BMJ  Open(2019) DOI: 10.1136/bmjopen-2018-026166

@NHSBT_RD

The new NHSBT Patient andPublic Advisory Group

The new NHSBT Patient and Public Advisory Group (PPAG) will ensure thatpatients and the public are involved and embedded in all aspects of the researchprocess at NHSBT.  This group is formed of members of the public, patients andcarers who all have an interest in clinical research. The PPAG is an extremely  valuable resource for NHSBT CTU, and will help us tostrengthen our current level of patient involvement and engagement.  For more information on this group, please visit  nhsbt.nhs.uk/research-and-development/patient-and-public-advisory-group

[email protected]

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A "TOPPS" Success!The TOPPS trial was managed by NHSBT CTU between 2005 and 2012. TOPPSwas a non-inferiority open-label randomised controlled trial in adults withhaematological malignancies who were receiving intensive chemotherapy or astem cell transplant. It compared only giving platelet transfusions when patientsbled to giving platelets when the platelet count was 10 x 10  /L or below(prophylactic) in addition to giving platelet transfusions when patients bled. It showed that in adults undergoing an autologous stem cell transplant, onlygiving platelet transfusions when patients bled was non-inferior to a prophylacticplatelet transfusion policy and reduced the number of platelet transfusions theyrequired. Whereas in adults receiving an allogeneic stem cell transplant orchemotherapy a therapeutic-only policy led to more people having clinicallysignificant bleeding.

4 full text publications

274 citations

Cited in 17 guidelines

Cited in 90 clinical reviews / book chapters

Included in 10 systematic reviews

Cited in 2 new RCT protocols

Stanworth SJ, Estcourt LJ, Powter GP, Kahan BC, DyerC, Choo L, Bakrania L, Llewelyn C, Littlewood T, .  (2013)A no-prophylaxis platelet-transfusion strategy forhematologic cancers. New England Journal of Medicine;368(19):1771-80.

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Chief Investigator:Dr Simon Stanworth

Funder:NHS Blood and Transplant

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Sponsor:NHS Blood and Transplant

Changed guidance in British Society of Haematology (BSH) Guidelines

“Consider not giving prophylactic platelet transfusions to well patients with no

evidence of bleeding who have had an autologous stem cell transplant (2B)”

Changed guidance in American Society of Clinical Oncology (ASCO)

Guidelines

"Platelet Transfusion Threshold in the Setting of Hematopoietic Stem-Cell

Transplantation - UPDATED:  The Panel recommends a threshold of < 10 ×

109/L for prophylactic platelet transfusion in adult and pediatric patients

undergoing allogeneic HSCT. Prophylactic platelet transfusion may be

administered at higher counts based on clinician judgment. In adult recipients

of autologous HSCT, randomized trials have demonstrated similar rates of

bleeding with decreased platelet usage when patients are transfused at the

first sign of bleeding rather than prophylactically, and this approach may be

used in experienced centers. This recommendation is not generalizable to

pediatric patients (Type of recommendation: evidence based; Evidence quality:

high; Strength of recommendation: moderate).”

A "TOPPS" Success!

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   Supporting

On 14th March 2019 (World Kidney Day!), the team took part in a swimathon,raising money for Kidney Research UK. In the UK there are currently 4,724 peopleon the waiting list for a kidney transplant. And since 1st April 2018, 2,906 kidneytransplants have taken place. These figures were combined to createour swimming target of 7,630 metres. As a team, we swam a total of 13,195 metres and raised just over £460 ! NHSBT CTU are currently supporting several kidney-related trials: - EVNP (Ex-Vivo Normothermic Perfusion)- ITOPS (Improving Transplant Opportunities for Patients who are Sensitised)- PITHIA (Pre-Implantation Trial of Histopathology In renal Allografts)- SONAR (Surveillance Of arterioveNous fistulAe using ultRasound)

Please see nhsbt.nhs.uk/clinical-trials-unit for further detail on these trials.  8

   Conference AttendanceThis year, the team have attended several conferences in order to raise awarenessof NHSBT CTU and meet potential new Chief Investigators. 

       NIHR CampaignThe team supported the national 'I AmResearch' campaign, which aims to  raiseawareness of the benefits of research and thepositive impact it has on people's lives.

Every year, more than half a million people help the NHS to improve healthcare anddevelop life-saving treatments by taking part in health research. This year, as well asmarking International Clinical Trials Day, the campaign celebrated the  70thanniversary of the NHS.

Photos from the day are included on the next page.  9

       International Clinical Trials Day (20th May 2018)

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This day marks the anniversary of the first clinical trial,conducted by James Lind in 1747. 

Build upon our current level of

patient involvement andengagement in research, in

collaboration with the NHSBTPatient and Public Advisory

Group

Publish the resultsof 4 trials which

have completed orare due to complete

shortly

Open at least3 new trials

Recruit a QualityAssurance Specialist,

dedicated to supportingthe CTU

Continue toactively promote

the CTU

Finalise our DataSharing Policy and

Publication Policy, forthe benefit of future

trials

Maintain a balancedportfolio of clinical

trials, covering all areasof NHS Blood and

Transplant's practice

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  Looking Ahead...In 2019 - 2020, we aim to:

  Social Media 

@CRYOSTAT_2@ItopsT

Websitesn h s b t . n h s . u k / c l i n i c a l - t r i a l s - u n i t

c r y o s t a t 2 . c o . u k

p i t h i a . o r g . u k

s o n a r t r i a l . o r g . u k

t r e a t t . o r g

@PITHIA_trial@PlaNeT2_trial

The Twitter accounts for our team are @NHSBT_CTU and@NHSBT_Stats. We also have several trial-specific accounts:

@SONAR_trial @TREATT_trial

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   NHSBT CTU  Team LEADERSHIP Lise EstcourtDirector Rachel JohnsonAssistant Director – Statistics andClinical Studies ADMINISTRATION Jayne GippBusiness Manager Anna WelfordClinical Trials Support Officer Chloe FitzpatrickClinical Trials Administrator STATISTICS Helen ThomasHead of Clinical Trial Statistics Cara HudsonPrincipal Statistician Laura PankhurstSenior Statistician Elinor CurnowSenior Statistician Alex GriffithsSenior Statistician Jo BunnettStatistician Joseph ParsonsStatistician

CLINICAL OPERATIONS Alison DearyHead of Operations Claire FoleyClinical Operations Manager Claire DyerClinical Operations Manager Ana MoraClinical Operations Manager Gillian PowterClinical Trial Manager Heather SmethurstClinical Trial Manager Anna SiddersClinical Trial Manager Emma LaingClinical Trial Manager Samaher SweityClinical Trial Manager Joanne LucasClinical Trial Manager Amy EvansClinical Trial Coordinator Val HopkinsClinical Trial Coordinator

DATA MANAGEMENT Renate HodgeHead of Clinical Data Services Katie KeenSenior Data Manager David CopeClinical Data Manager Rupa SharmaJunior Clinical Data Manager Siobhan MartinJunior Clinical Data Manager Emily ArbonData Management Support Officer Nikki DallasData Management Support Officer

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