PROlonged posterior PERicardial drainage to reduce rates of postoperative atrial fibrillation following cardiac surgery – The PROPER trial

The purpose of this project is to develop trial protocols, apply for funding, acquire resources for data management, establish an eCRF and randomization platform, develop a statistical plan and conduct a power calculation and to recruit additional clinical sites for participation in the study.

Furthermore, approved grants will be used for funding a study-coordinator and a doctoral student who will participate in activities mentioned above and receive neccessary training for conducting the study.

Several studies have shown that evacuation of pericardial blood results in reduced rates of POAF after cardiac surgery by 45-68% (references 22-25 in the research program).

However, these studies have either been based on posterior pericardiotomy, or to undersized to allow for generalizable conclusions regarding the effects of prolonged posterior chest tube treatment.

The aim of this study is to evaluate whether prolonged treatment with a posterior pericardial chest tube may reduce the frequency of POAF after routine cardiac surgery in a prospective, 1:1 randomized, controlled, interventional multi-center trial.The study will be planned together with Kristina Johansson and Dr Susann Ullén at Clinical Studies Sweden (CSS) during 2024 and we plan on including the first patient in 2025.

Funding from SRC would allow us to use the expertise from CSS to establish the study infrastructure, ensure the statistical quality and facilitate applications and recruitment of additional sites.