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NCT Number: NCT07505966

Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Faculty of Medicine, Asyut, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years) undergoing cardiac surgery via median sternotomy, including CABG, valve surgery, or combined procedures.

Placement of mediastinal chest tubes postoperatively

Exclusion criteria

  • Redo sternotomy

Surgery for acute aortic dissection

Heart transplantation

Mechanical circulatory support implantation

Incomplete or missing essential medical records

Intraoperative death

Treatment and study plan

Primary outcomes

  1. Incidence of Retained Blood Syndrome (RBS) after cardiac surgery

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Composite outcome including reoperation for bleeding, cardiac tamponade requiring procedural intervention, hemothorax requiring additional drainage, or retained intrathoracic clot requiring procedural management. Data will be collected retrospectively from patient medical records.

Secondary outcomes

  1. Reoperation for bleeding

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    ny surgical re-intervention performed due to postoperative bleeding documented in the patient's medical records

  2. Incidence of cardiac tamponade requiring procedural intervention

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Documented cases of cardiac tamponade after surgery that required percutaneous or surgical intervention for management

  3. Incidence of hemothorax requiring additional drainage

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Cases in which postoperative hemothorax necessitated additional chest tube placement or drainage procedures

  4. Incidence of chest tube occlusion

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Documented loss of chest tube patency requiring manipulation, flushing, or replacement

  5. Incidence of postoperative atrial fibrillation

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Occurrence of new-onset atrial fibrillation after surgery documented in patient monitoring records or ECG reports

  6. Intensive Care Unit (ICU) length of stay

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Total number of days spent in the ICU postoperatively.

  7. Total hospital length of stay

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Total number of days from the day of surgery to hospital discharge.

  8. All-cause mortality within 30 days postoperatively

    Time frame: "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel"

    Any death occurring within 30 days after the index cardiac surgery.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Acronym: CLEAR-CS Stu

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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