Objectives: Evidence to support the use of pericardial drainage instead of simple pericardiocentesis for nonmalignant pericardial effusions refractory to medical therapy is based on observational studies and experts' opinions, rather than randomized trials. The aim of the present trial is to fill this knowledge gap and to provide a stronger base of evidence to support a specific interventional treatment in this setting.
Methods: DRainage Or Pericardiocentesis (DROP) alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention is a randomized, open-label and multicenter study. The primary efficacy endpoints are the incidence of recurrent pericardial effusion, and the need for additional pericardiocentesis or cardiac surgery at 12 months. Secondary endpoints are hospital length stay, disease-related admission and overall mortality. Safety and complications rates of each intervention will be also assessed.
Implications and conclusion: The DROP trial will be the first multicenter randomized trial to evaluate the efficacy and safety of pericardiocentesis versus pericardiocentesis and extended pericardial drainage for recurrent nonmalignant, nonbacterial pericardial effusions refractory to medical therapy and requiring interventional treatments (ClinicalTrials.gov Identifier: NCT01665495).