title: The efficacy and safety of complete pericardial drainage by means of intrapericardial fibrinolysis for the prevention of complications of pericardial effusion: a systematic review protocol.
abstract: BACKGROUND
  Intrapericardial fibrinolysis has been proposed as a means of preventing complications of pericardial effusion such as cardiac tamponade, persistent and recurrent pericardial effusion, and pericardial constriction. There is a need to understand the efficacy and safety of this procedure because it shows promise.
  
  
  METHODS
  We aim to assess the effects of intrapericardial fibrinolysis in the treatment of pericardial effusion. We will search PubMed, the Cochrane Library, African Journals online, Cumulative Index to Nursing and Allied Health Literature, Trip database, Clinical trials.gov and the WHO International Clinical Trials Registry Platform for studies that evaluate the efficacy and/or safety of complete pericardial fluid drainage by intrapericardial fibrinolysis irrespective of study design, geographical location, language, age of participants, aetiology of pericarditis or types of fibrinolytics. Two authors will do the search independently, screen the search outputs for potentially eligible studies and assess whether the studies meet the inclusion criteria. Discrepancies between the two authors will be resolved through discussion and arbitration by a third author. Data from the selected studies shall be extracted using a standardised data collection form which will be piloted before use. The methodological quality of studies will be assessed using the Cochrane Collaboration's tools for assessing risk of bias for experimental studies and non-randomised studies, respectively. The primary meta-analysis will use random effects models due to expected interstudy heterogeneity. Dichotomous data will be analysed using relative risk and continuous with data mean differences, both with 95% CIs.
  
  
  BACKGROUND
  Approval by an ethics committee is not required for this study as it is a protocol for a systematic review of published studies. The results will be disseminated through a conference presentation and peer-reviewed publication.
  PROSPERO, CRD42014015238.
authors.affiliation: Department of Family Medicine and Rural Health, Walter Sisulu University, Mthatha, South Africa.
authors.forename: Aloysious
authors.initials: A
authors.lastname: Kakia
authors.affiliation: Centre for Evidence-based Health Care, Stellenbosch University, Cape Town, South Africa Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Wiysonge
authors.affiliation: Centre for Evidence-based Health Care, Stellenbosch University, Cape Town, South Africa.
authors.forename: Eleanor A
authors.initials: EA
authors.lastname: Ochodo
authors.affiliation: Department of Medicine, Nelson Mandela Academic Hospital and Walter Sisulu University, Mthatha, South Africa.
authors.forename: Abolade A
authors.initials: AA
authors.lastname: Awotedu
authors.affiliation: Department of Cardiology, Clinical Center of Serbia and Belgrade University School of Medicine, Belgrade, Serbia.
authors.forename: Arsen D
authors.initials: AD
authors.lastname: Ristic
authors.affiliation: Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.
authors.forename: Bongani M
authors.initials: BM
authors.lastname: Mayosi
mesh_terms: D004322:Drainage / Q000379:methods*; D005342:Fibrinolysis; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D010490:Pericardial Effusion / Q000150:complications / Q000628:therapy*; D010496:Pericardium / Q000473:pathology*; D012107:Research Design; D000078202:Systematic Reviews as Topic; D015912:Thrombolytic Therapy; D015201:Meta-Analysis as Topic
chemical_list: D005343:Fibrinolytic Agents
keywords: PREVENTIVE MEDICINE