Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery (CLEAR-CS Stu)

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

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

Study Overview

• Status: Completed
• Conditions: Retained Blood Syndrome; Open Heart Surgery; Chest Tube

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Assiut University Faculty of Medicine
  • Banī Suwayf, Egypt
    • Beni Suef University Faculty of Medicine
  • Cairo, Egypt, 02
    • Cairo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who underwent cardiac surgery with mediastinal chest tube placement at participating tertiary cardiac surgery centers. Data will be collected retrospectively from medical records; no direct patient contact occurs.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Active Chest Tube Clearance; Patients managed with active chest tube clearance techniques intended to maintain chest tube patency and facilitate continuous evacuation of postoperative blood. No additional interventions are applied beyond standard care.
Standard Passive Chest Tube Drainage; Patients managed with standard passive chest tube drainage following cardiac surgery. No additional interventions are applied beyond standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Retained Blood Syndrome (RBS) after cardiac surgery	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.	"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"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation for bleeding	ny surgical re-intervention performed due to postoperative bleeding documented in the patient's medical records	"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"
Incidence of cardiac tamponade requiring procedural intervention	Documented cases of cardiac tamponade after surgery that required percutaneous or surgical intervention for management	"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"
Incidence of hemothorax requiring additional drainage	Cases in which postoperative hemothorax necessitated additional chest tube placement or drainage procedures	"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"
Incidence of chest tube occlusion	Documented loss of chest tube patency requiring manipulation, flushing, or replacement	"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"
Incidence of postoperative atrial fibrillation	Occurrence of new-onset atrial fibrillation after surgery documented in patient monitoring records or ECG reports	"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"
Intensive Care Unit (ICU) length of stay	Total number of days spent in the ICU postoperatively.	"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 hospital length of stay	Total number of days from the day of surgery to hospital discharge.	"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"
All-cause mortality within 30 days postoperatively	Any death occurring within 30 days after the index cardiac surgery.	"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"

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FM-BSU REC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers. The study involves retrospective analysis of de-identified patient data collected from institutional medical records. Data sharing is restricted due to institutional policies and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No