Retained Blood SyndromeCLEAR-CS StuNCT07505966
Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery
An observational study of Retained Blood Syndrome and Open Heart Surgery, run by Kasr El Aini Hospital at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retained Blood Syndrome, Open Heart Surgery, Chest Tube
- How many people
- 250 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jan 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (≥18 years) undergoing cardiac surgery via median sternotomy, including CABG, valve surgery, or combined procedures.
- Placement of mediastinal chest tubes postoperatively
Who cannot join
- Redo sternotomy
- Surgery for acute aortic dissection
- Heart transplantation
- Mechanical circulatory support implantation
- Incomplete or missing essential medical records
- Intraoperative death
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Assiut University Faculty of Medicine
Asyut
Beni Suef University Faculty of Medicine
Banī Suwayf
Cairo University Hospital
Cairo, 02
About this study
Official title: 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.
Read more
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
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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
ny surgical re-intervention performed due to postoperative bleeding documented in the patient's medical records
Measured: "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
Measured: "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
Measured: "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
Measured: "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
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Jan 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Blood SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamdy Lamloum, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505966
- Sponsor's protocol ID
- FM-BSU REC
- Acronym
- CLEAR-CS Stu
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Chest Tube Clearance Versus Standard Drainage After Cardiac Surgery: A Multicenter Retrospective Cohort Study Evaluating Retained Blood Syndrome and Bleeding-Related Outcomes
- ClinicalTrials.gov ID
- NCT07505966
- Acronym / sponsor ID
- CLEAR-CS Stu / FM-BSU REC
- Conditions
- Retained Blood Syndrome, Open Heart Surgery, Chest Tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) undergoing cardiac surgery via median sternotomy, including CABG, valve surgery, or combined procedures.
- Placement of mediastinal chest tubes postoperatively
Key exclusion criteria (6 listed)
- Redo sternotomy
- Surgery for acute aortic dissection
- Heart transplantation
- Mechanical circulatory support implantation
- Incomplete or missing essential medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
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"
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"
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"
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"
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"
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 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"
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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Blood Syndrome and Open Heart Surgery, run by Kasr El Aini Hospital at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.