Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention

Maria Vittoria Hospital

Status: Unknown

Conditions: Pericardial Effusion

Treatments: Procedure: Extended pericardial drainage by catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01665495

72/16/11

Details and patient eligibility

About

The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.

Full description

The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• pericardial effusion requiring pericardiocentesis
• non-malignant etiology

Exclusion criteria

• known neoplastic etiology
• known bacterial etiology

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Pericardiocentesis

No Intervention group

Description:

Pericardial fluid drained by simple echo-guided pericardiocentesis

Extended pericardial drainage

Active Comparator group

Description:

Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return\<30ml

Treatment:

Procedure: Extended pericardial drainage by catheter