Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery

NCT07505966 | Completed

• 1 other identifier: FM-BSU REC
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Retained Blood Syndrome; Open Heart Surgery; Chest Tube

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Reoperation for bleeding

  "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

  "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

  "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

  "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

  "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"

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients (≥18 years) undergoing cardiac surgery via median sternotomy, including CABG, valve surgery, or combined procedures.
• Placement of mediastinal chest tubes postoperatively

You may not qualify if:

• Redo sternotomy
• Surgery for acute aortic dissection
• Heart transplantation
• Mechanical circulatory support implantation
• Incomplete or missing essential medical records
• Intraoperative death

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (3)

Assiut University Faculty of Medicine

Asyut, Egypt

Location

Beni Suef University Faculty of Medicine

Banī Suwayf, Egypt

Location

Cairo University Hospital

Cairo, 02, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate proffessor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 1, 2026
• Study Start: January 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)