Traditionally, this has involved artificial heart valves, similar to those used in the treatment of adults. But these have several serious disadvantages: Firstly, artificial heart valves don’t grow with the children, they are also frequently rejected – this means in following years, additional operations are necessary to replace them. Moreover, children need to take blood-thinning medication.
Over ten years ago, the clinic began to research a visionary alternative: the children should receive real, decellularized heart valves from human donors. This entails chemically removing the proteins of the donors from the heart valves.
The proposition: “homograft” treatments should be more readily accepted by the hosting body and grow with the developing child – just like a real heart valve. Along with this, the clinic started an international research project that was supported by EU funding: the European clinical study of regenerative heart valves, or ESPOIR for short.
The children that were treated were closely monitored for years to prove the success of the new treatment. The development of the heart valves used was tracked with the help of regular MRI scans (magnetic resonance imaging).
TrialComplete facilitates collaboration in international research projects. Data from all parties is transparently connected. This forms a solid basis for the evaluation of clinical studies. The user-friendliness also increases through the resolution of media disruptions between different systems – one system reliably covers all requirements, allowing the study to be carried out in a conscientious way.
Storage for the extensive image data is also automatically scalable. IT investments and maintenance for application or infrastructure are no longer required as the effort and resources needed to maintain the IT components are provided in full by T-Systems.
This takes the pressure off researchers, enabling them to focus on the tasks that are truly relevant: solid study results that can give children with heart problems a better quality of life.
We are delighted that Telekom Healthcare Solutions has developed a system that securely combines pseudonymized MRI and study data.
Dr. Samir Sarikouch, clinical study leader and senior physician at Hannover Medical School
The long-term study produces many terabytes of data from the imaging procedures. These are supplied from many different PAC systems (picture archiving and communication) from connected clinics from Moldova, Italy, France, Belgium, Great Britain, and the Netherlands.
Images are only part of the study. To produce valid claims, they need to be connected with the right medical data from the patients. Separate systems are usually used for the storage of medical data.
Further problems can occur through the pseudonymization required for the protection of different data, meaning that experts in clinical studies assume that they cannot use a significant part of the collected data as the classification is not clear.
The process for the clinical studies required a solution that not only facilitated the clear classification of the data over long study periods, but one that also protects the personal data of the participating children reliably and supports the collaboration of the project in a targeted way.
“These requirements are obvious – but such a system was not available on the market”, explains Dr. Samir Sarikouch, clinical study leader and senior physician at MHH. A large part of the research was still carried out manually. For the clinic, this approach was not acceptable for an international project. The study system TrialComplete, developed at that time by Telekom Healthcare Solutions, enables the pseudonymization and archiving of medical and image data in a standardized data format (DICOM) and therefore supports the study process. Access to the web application takes place over the internal clinic PC via Client – this also applies for the clinics taking part in the study in other European countries. Installation or the purchase of licenses is not necessary. The application itself is operated in a T-Systems data center. This means also in terms of infrastructure, all security and data protection requirements are fulfilled. So for ESPOIR, TrialComplete was the perfect option. “TrialComplete offers researching scientists a ‘single point of truth’ – data is stored centrally and can also be sorted and processed by us. We can immediately see the filtered data sets and start working”, Dr. Sarikouch summarizes. Through its operation on a private cloud, TrialComplete is scalable. If the number of participants in a study dramatically increases, the cloud can make additional resources available, thereby securing a user-friendly working experience.