NCT07505966

Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery

Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery: A Multicenter Retrospective Cohort Study Evaluating Retained Blood Syndrome and Bleeding-Related Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Title: CLEAR-CS Study - Active Chest Tube Clearance After Cardiac Surgery This study looks at two methods of removing blood and fluid from the chest after heart surgery. After cardiac operations, patients usually have chest tubes placed to drain blood and fluid. Sometimes these tubes get blocked, leading to retained blood inside the chest. This can cause complications such as the need for another surgery, heart compression, or longer hospital stays. The study compares patients who received active chest tube clearance, a method designed to keep the tubes open and remove blood continuously, with patients who received standard passive chest tube drainage. Researchers will review medical records from three heart surgery centers to see which method is associated with fewer complications, less bleeding, and shorter hospital stays. No additional procedures will be performed as part of this study. Purpose: To evaluate whether active chest tube clearance improves safety and outcomes after heart surgery compared to standard drainage. Who Can Participate: This study uses data from adult patients (18 years and older) who underwent heart surgery with chest tubes placed. No new patients will be enrolled. Duration of Participation: Data from the period 2022-2024 will be analyzed. Risks and Benefits: There is no direct risk to patients, as no new procedures are being performed. The study may help improve chest drainage practices and reduce complications for future patients

Detailed description

Detailed Description This multicenter retrospective cohort study evaluates the safety and effectiveness of active chest tube clearance compared to standard passive chest tube drainage in adult patients undergoing cardiac surgery via median sternotomy. Background: Postoperative bleeding and retained blood within the chest are common complications following cardiac surgery. Retained blood can lead to Retained Blood Syndrome (RBS), which includes reoperation for bleeding, cardiac tamponade, hemothorax requiring intervention, and retained intrathoracic clot necessitating procedural management. These complications are associated with increased morbidity, longer ICU and hospital stays, and higher healthcare costs. Study Objectives: Primary Objective: Compare the incidence of RBS between patients managed with active chest tube clearance versus standard passive drainage. Secondary Objectives: Assess differences in reoperation for bleeding, cardiac tamponade, hemothorax requiring drainage, postoperative blood transfusion requirements, chest tube occlusion, postoperative atrial fibrillation, ICU length of stay, hospital length of stay, and 30-day mortality. Study Design: Type: Observational, retrospective, multicenter cohort study. Data Collection: Medical records from three tertiary cardiac surgery centers will be reviewed over a 3-year period (January 2022 - December 2024). Population: Adult patients (≥18 years) who underwent cardiac surgery (CABG, valve surgery, or combined procedures) and had mediastinal chest tubes placed. Exclusions: Redo sternotomy, acute aortic dissection surgery, heart transplantation, mechanical circulatory support implantation, incomplete medical records, or intraoperative death. Groups: Group A: Active chest tube clearance strategy Group B: Standard passive chest tube drainage Definitions: Retained Blood Syndrome (RBS): Any of reoperation for bleeding, cardiac tamponade requiring intervention, hemothorax requiring drainage, or retained clot requiring procedural management. Chest Tube Occlusion: Documented loss of drain patency requiring manipulation, flushing, or replacement. Data Collection Variables: Demographics: Age, sex, BMI Preoperative Variables: Diabetes, hypertension, chronic kidney disease, anticoagulant/antiplatelet therapy, LVEF, urgency status Operative Variables: Procedure type, cardiopulmonary bypass time, aortic cross-clamp time, number/size of chest tubes Postoperative Variables: Chest tube output, reoperation, transfusions, atrial fibrillation, ICU and hospital stay, 30-day mortality Sample Size: Approximately 200-300 patients (100-150 per group), based on case availability, providing sufficient power to detect clinically meaningful differences in RBS incidence. Statistical Analysis: Continuous variables: mean ± SD or median (IQR) Categorical variables: frequencies and percentages Between-group comparisons: Student's t-test, Mann-Whitney U test, chi-square or Fisher's exact test Multivariable logistic regression to identify independent predictors of RBS Propensity score analysis if significant baseline differences exist Center and surgeon effects will be explored and adjusted for Significance: p \< 0.05 Ethical Considerations: Retrospective, observational study No interventions beyond standard care Data anonymized and stored securely Waiver of informed consent requested due to minimal risk Potential Benefits: While no direct benefit to participants exists, the study may improve postoperative chest drainage strategies, reduce retained blood complications, and optimize perioperative outcomes in future cardiac surgery patients. Timeline: Month 0: Ethical approval Months 1-3: Data collection Month 4: Statistical analysis Months 5-6: Manuscript preparation Funding: None Conflicts of Interest: None

Conditions

• Retained Blood Syndrome
• Open Heart Surgery
• Chest Tube

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

3 sites across 1 country: Egypt