Safety interim analysis

Rationale:

Evidence regarding the timing of chest tube removal after cardiac surgery is sparse. The timing of chest tubes removal constitutes a balancing act between risk of retained blood syndrome, infection, patient discomfort and opioid-related side effects. Several studies have shown that chest tubes can safely be removed on the first postoperative day compared to later. A single retrospective study raised concern as chest tube removal on the day of surgery was associated with an increased requirement of drainage of pleural effusions.

Primary Objective:

To compare the impact of two standard chest tube removal protocols following open-heart surgery on the incidence of pleural and/or pericardial effusion requiring invasive drainage

Secondary Objectives

To evaluate the impact of chest tube removal on the day of surgery (DAY0) compared to the first postoperative day (DAY1) regarding:

• Comsumption of analgetic drugs
• Early postoperative pain
• Incidence of infection
• Early postoperative respiratory function

Study design:

Single-center, open, parallel-group, prospective, cluster-randomized controlled trial Alternate assignment of chest tube removal according to Day 0 versus Day 1 protocol based upon the month of surgery (even versus odd months).

Study population:

1300 consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.

Inclusion Criteria:

All consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.

Exclusion Criteria:

Cardiac procedures deemed not eligible to chest tube removal on the day of surgery due to increased bleeding risk due to:

• Procedures in hypothermic circulatory arrest
• Previous cardiac surgery
• Procedures performed through upper hemisternotomy
• Emergent treatment required (< 24 hours)
• Non-aspirin antiplatelet drugs stopped < 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine)
• Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants
• Platelet count > 450 or <100 x 109/l prior to surgery

Individual-level deidentified patient data that support the findings of this study, and statistical analysis plan are available upon reasonable request.

Data will be available beginning immediately and ending five years after article publication.

Data sharing with other researchers requires a methodologically sound proposal (detailed protocol for the proposed study, information about the funding and resources) and approval by the Danish Data Protection Agency.