CABGNCT07194798
Drainage Technique in CABG
An observational study of CABG and Atrial Fibrillation (AF), run by Assiut University.
Trial summary
aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG, Atrial Fibrillation (AF)
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will include adult patients scheduled to undergo elective, first-time, isolated coronary artery bypass grafting (CABG) surgery via median sternotomy. Eligible participants will be hemodynamically stable and able to provide informed consent prior to enrollment. Patients will be randomized intraoperatively to receive either a posterior pericardial window or a retro-cardiac drain for postoperative management.
Who may be able to join
- Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
- Patients with preserved left ventricular function (ejection fraction ≥ 35%).
- Ability to provide informed consent and comply with follow-up protocols.
- No prior history of atrial fibrillation or other significant arrhythmias.
Who cannot join
- Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
- Emergency CABG cases or re-operations.
- Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
- Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
- Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
- Patients with active infections or systemic inflammatory conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Trial Comparing the Posterior Pericardial Window Versus Retro-Cardiac Drain for the Prevention of Postoperative Atrial Fibrillation and Pericardial Complications Following CABG
aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.
Read the detailed description
Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.
Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.
The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.
Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.
- Conditions
- CABG, Atrial Fibrillation (AF)
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage. | Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. | |
| Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. | Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative atrial fibrillation and pericardial complications
Postoperative atrial fibrillation will be detected by continuous ECG monitoring during hospitalization. Pericardial complications, including early and late pericardial effusion, cardiac tamponade, and pleural effusion, will be assessed using echocardiography. The outcome will be reported as the number and percentage of participants experiencing any of these events.
Measured: During hospitalization and up to 3 months after surgery
Secondary outcomes (1)
Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)
Postoperative outcomes will include:
Length of ICU stay and total hospital stay (measured in days from surgery until discharge).
Requirement for revision surgery due to bleeding (documented from operative and postoperative records).
All-cause in-hospital mortality (death from any cause during index hospitalization).
These outcomes will be reported as duration in days and/or number and percentage of participants, as appropriate.
Measured: From surgery until hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Saad Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194798
- Sponsor's protocol ID
- Drainage technique in CABG
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390.
PubMed 8759081Kalavrouziotis D, Buth KJ, Ali IS. The impact of new-onset atrial fibrillation on in-hospital mortality following cardiac surgery. Chest. 2007 Mar;131(3):833-839. doi: 10.1378/chest.06-0735.
PubMed 17356100Almassi GH, Schowalter T, Nicolosi AC, Aggarwal A, Moritz TE, Henderson WG, Tarazi R, Shroyer AL, Sethi GK, Grover FL, Hammermeister KE. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997 Oct;226(4):501-11; discussion 511-3. doi: 10.1097/00000658-199710000-00011.
PubMed 9351718Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.
PubMed 15082699Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.
PubMed 11747385Xiong T, Pu L, Ma YF, Zhu YL, Li H, Cui X, Li YX. Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials. J Cardiothorac Surg. 2021 Aug 14;16(1):233. doi: 10.1186/s13019-021-01611-x.
PubMed 34391454Ranjan R, Kapetanakis S, Chandrasekaran V, Kaba RA, Momin AU. Posterior Pericardial Window and a Single Pleural Drain: A Dual Defence Against Post-CABG Pericardial Effusion and Atrial Fibrillation. Ther Clin Risk Manag. 2025 Apr 15;21:481-487. doi: 10.2147/TCRM.S521874. eCollection 2025.
PubMed 40255667
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing the Posterior Pericardial Window Versus Retro-Cardiac Drain for the Prevention of Postoperative Atrial Fibrillation and Pericardial Complications Following CABG
- ClinicalTrials.gov ID
- NCT07194798
- Acronym / sponsor ID
- Drainage technique in CABG
- Conditions
- CABG, Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Sep 2025 (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.
aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.
Detailed description
Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.
Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.
The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.
Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage. | – | –Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. |
| Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. | – | –Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients scheduled to undergo elective, first-time, isolated coronary artery bypass grafting (CABG) surgery via median sternotomy. Eligible participants will be hemodynamically stable and able to provide informed consent prior to enrollment. Patients will be randomized intraoperatively to receive either a posterior pericardial window or a retro-cardiac drain for postoperative management.
Key inclusion criteria (4 listed)
- Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
- Patients with preserved left ventricular function (ejection fraction ≥ 35%).
- Ability to provide informed consent and comply with follow-up protocols.
- No prior history of atrial fibrillation or other significant arrhythmias.
Key exclusion criteria (6 listed)
- Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
- Emergency CABG cases or re-operations.
- Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
- Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
- Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
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 postoperative atrial fibrillation and pericardial complications
Time frame: During hospitalization and up to 3 months after surgery
Postoperative atrial fibrillation will be detected by continuous ECG monitoring during hospitalization. Pericardial complications, including early and late pericardial effusion, cardiac tamponade, and pleural effusion, will be assessed using echocardiography. The outcome will be reported as the number and percentage of participants experiencing any of these events.
1 secondary outcome
Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)
Time frame: From surgery until hospital discharge (up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Results publication: PubMed 8759081Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390.
- Results publication: PubMed 17356100Kalavrouziotis D, Buth KJ, Ali IS. The impact of new-onset atrial fibrillation on in-hospital mortality following cardiac surgery. Chest. 2007 Mar;131(3):833-839. doi: 10.1378/chest.06-0735.
- Results publication: PubMed 9351718Almassi GH, Schowalter T, Nicolosi AC, Aggarwal A, Moritz TE, Henderson WG, Tarazi R, Shroyer AL, Sethi GK, Grover FL, Hammermeister KE. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997 Oct;226(4):501-11; discussion 511-3. doi: 10.1097/00000658-199710000-00011.
- Results publication: PubMed 15082699Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.
- Results publication: PubMed 11747385Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.
- Results publication: PubMed 34391454Xiong T, Pu L, Ma YF, Zhu YL, Li H, Cui X, Li YX. Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials. J Cardiothorac Surg. 2021 Aug 14;16(1):233. doi: 10.1186/s13019-021-01611-x.
- Results publication: PubMed 40255667Ranjan R, Kapetanakis S, Chandrasekaran V, Kaba RA, Momin AU. Posterior Pericardial Window and a Single Pleural Drain: A Dual Defence Against Post-CABG Pericardial Effusion and Atrial Fibrillation. Ther Clin Risk Manag. 2025 Apr 15;21:481-487. doi: 10.2147/TCRM.S521874. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of CABG and Atrial Fibrillation (AF), run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed mohamed saad, Principal Investigator (+201014570052, Ahmed.17289818@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative atrial fibrillation and pericardial complications (time frame: During hospitalization and up to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194798, which also lists 7 linked publications.
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 26 Sep 2025.