TRAIT

 

Real World Use of Thrombopoeitin Agonists in the Management of Immune Thrombocytopenia (TRAIT Study)

TRAIT is a research study examining the “real world” use of Thrombopoetin-Receptor Agonists (TRAs) in the management of Immune Thrombocytopenia (ITP) in the UK. It is led by Nichola Cooper from Imperial College Healthcare NHS Trust.

There are few randomised controlled trials looking at TRAs, such as romiplostim (Nplate) or eltrombopag (Revolade) and therefore limited information on the benefits  and potential harms with long term use, either as 3rd line agents in ITP (after 2 prior treatment types) or in situations where they are used earlier on in the course of treatment or for treatment of ITP caused by another illness (secondary ITP).

This retrospective study recruited patients who were ≥18 years old, had primary or secondary ITP and had received their first prescription for a TRA at least 3 months before being entered into the study.

The study measured response rates, the duration of response and also adverse events and  reactions occurring whilst on these medications. It aimed to recruit 200 patients over a 12 month period during 2017 and 2018.

Initially 5 sites were opened across the UK.  Before HaemSTAR involvement, recruitment started strongly but tailed off after the first six months.  At this point HaemSTAR expressed interest and the study sponsor granted increased funding for 5 further sites to be supported by HaemSTAR.


Five HaemSTAR sites opened rapidly enabling ongoing, above-target recruitment

The Impact of HaemSTAR on the Numbers of Patients Consented to the TRAIT Study since the beginning of our involvement in May 2017

After the success of the initial 5 sites, further funding was given for 5 more sites and the study was extended by 4 months and the target increased to 250 patients.

Overall 104 of the 268 recruited patients were through 8 HaemSTAR supported sites. The study closed after successfully recruiting ahead of time and target.

Interim results were reported at the 2018 BSH Annual Scientific Meeting in April 2018 and final results are planned to be reported at the American Society of Haematology Annual Congress in December 2018. 


Real-World Financial Benefit to the NHS from HaemSTAR's Involvement

Through directly attributable HaemSTAR efforts, the NHS received real-world income of £25,100 from the TRAIT study.