CASE STUDY

The THERMIC-3 Study

UNIVERSITY HOSPITAL BRISTOL

Intermittent Antegrade Warm Blood versus Cold Blood Cardioplegia in Children Undergoing Open Heart Surgery: A Prospective, Multicentre, Randomised Controlled Trial

The THERMIC-3 Study animation and website preview

Summary

During heart surgery, we stop the heart and use a heart-lung bypass machine to pump blood around the body. To keep the heart still during surgery we use a solution called ‘cardioplegia’ that also contains substances to protect the heart. At the moment it is normal for a cold cardioplegia solution to be used ‘cold blood cardioplegia’. However, we now think that it could be better to use a warm cardioplegia solution ‘warm blood cardioplegia’ instead.

Research suggests that using a warm solution in heart surgery on adults is less harmful than using a cold one. However, little is known about the effects of using warm cardioplegia solutions in children. Therefore, the study will compare the two cardioplegia temperatures used (‘cold’ or ‘warm’ blood cardioplegia) and look at their effects on the heart and recovery after heart surgery for paediatric patients.

What we did

This was one of the TRECA trials so we produced the recruitment range of resources. In this trial there was the requirement to create different versions of the website to match the age groupings within their Patient Information Sheets. This was part of the TRECA solution and so we created sites for three age groupings (up to 10 years, 11-15 years and 16+ years). Acknowledging that the Patient Information Websites for older children and teenagers (11-15 years and 16+ years) would be very similar in wording and other content.

There was also a further version of the websites produced to communicate information about the TUB sub-study. This part of the research was concerned with measuring the temperatures of participants during and after the procedure that they only wanted to be easily accessible to older participants (16+ years).

Digitrial by Morph Participant Information Sheet Examples on various devices

Study & Patient Information solution

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