title: DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention: rationale and design of the DROP trial, a randomized, open-label, multicenter study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: aCardiology Department, Maria Vittoria Hospital, Torino bCardiology CRO, National Cancer Institute, Aviano, Italy cHarrington Heart and Vascular Institute, University Hospitals Case Medical Center, Cleveland, Ohio dCardiology Unit, Fletcher Allen Healthcare, Burlington eInternal Medicine Department, St. Vincent Hospital, Worcester, Massachusetts, USA fChaim Sheba Medical Center, Tel Hashomer and Sacker Faculty of Medicine, Tel Aviv, Israel.
authors.forename: Massimo
authors.initials: M
authors.lastname: Imazio
authors.forename: Riccardo
authors.initials: R
authors.lastname: Belli
authors.forename: Federico
authors.initials: F
authors.lastname: Beqaraj
authors.forename: Massimo
authors.initials: M
authors.lastname: Giammaria
authors.forename: Chiara
authors.initials: C
authors.lastname: Lestuzzi
authors.forename: Brian
authors.initials: B
authors.lastname: Hoit
authors.forename: Martin
authors.initials: M
authors.lastname: LeWinter
authors.forename: David H
authors.initials: DH
authors.lastname: Spodick
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Adler
mesh_terms: D004322:Drainage / Q000009:adverse effects / Q000379:methods*; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D010490:Pericardial Effusion / Q000628:therapy*; D020519:Pericardiocentesis / Q000009:adverse effects / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012008:Recurrence; D012107:Research Design