Pericardial EffusionBlakeNCT00684125
Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery
A study testing Blake Drains (Blake drain, Ethicon USA) and Standard mediastinal drainage in people with Pericardial Effusion and Late Cardiac Tamponade, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pericardial Effusion, Late Cardiac Tamponade, Surgical Reintervention
- What is being tested?
- Blake Drains (Blake drain, Ethicon USA) and Standard mediastinal drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jul 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 90 years old, undergoing either surgery of the ascending and/or transverse aorta, or surgery of the mitral and/or aortic valves
- Availability for follow-up at the Montreal Heart Institute Exclusion criteria
Who cannot join
- Emergency surgery
- Unavailability for follow-up at the Montreal Heart Institute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. A prospective randomized trial.
Read the detailed description
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. Patients undergoing aortic and / or valvular surgery will be randomized in two groups. In group A, mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. In group B, mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. In both groups, conventional chest tubes will be removed on the first postoperative day, while patients in the group A will have prolonged drainage using the Blake drain until output is less than 50 ml over 24 hour. Patients will be followed during their postoperative course for occurrence of significant pericardial effusion as detected on routine echocardiogram and late cardiac tamponade requiring reintervention.
- Being tested
- Blake Drains (Blake drain, Ethicon USA), Standard mediastinal drainage
- Keywords
- late cardiac tamponade
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blake Drains (Blake drain, Ethicon USA)Device
Also called Blake drain: prolonged mediastinal drainage
19F Blake drain located in the posterior pericardial cavity
Standard mediastinal drainageDevice
Also called mediastinal drainage
Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. Receives: Device: Blake Drains (Blake drain, Ethicon USA) |
| 2 | Active comparator | mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. Receives: Device: Standard mediastinal drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention.
Measured: Day 5 - post surgery
Secondary outcomes (1)
Total volume of mediastinal drainage. Pain intensity on postoperative days 1 to 5. Incidence of postoperative atrial fibrillation Drain-associated infection or any other drain-associated adverse event.
Measured: Days 1 or till discharge - post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionJul 2010
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 Pericardial EffusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Phillippe Demers, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684125
- Sponsor's protocol ID
- ICM 07-934
- Acronym
- Blake
- Status last verified
- Jul 2011
- First submitted
- 21 May 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049.
PubMed 16798298Agati S, Mignosa C, Gitto P, Trimarchi ES, Ciccarello G, Salvo D, Trimarchi G. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1306-9. doi: 10.1016/j.jtcvs.2006.02.013.
PubMed 16733162Ege T, Tatli E, Canbaz S, Cikirikcioglu M, Sunar H, Ozalp B, Duran E. The importance of intrapericardial drain selection in cardiac surgery. Chest. 2004 Nov;126(5):1559-62. doi: 10.1378/chest.126.5.1559.
PubMed 15539727Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg. 2000 Sep;70(3):1109-10. doi: 10.1016/s0003-4975(00)01800-2.
PubMed 11016389Kuvin JT, Harati NA, Pandian NG, Bojar RM, Khabbaz KR. Postoperative cardiac tamponade in the modern surgical era. Ann Thorac Surg. 2002 Oct;74(4):1148-53. doi: 10.1016/s0003-4975(02)03837-7.
PubMed 12400760Shah A, van den Brink A, de Mol B. Raised international normalized ratio: an early warning for a late cardiac tamponade? Ann Thorac Surg. 2006 Sep;82(3):1090-1. doi: 10.1016/j.athoracsur.2006.01.035.
PubMed 16928545Moss E, Miller CS, Jensen H, Basmadjian A, Bouchard D, Carrier M, Perrault LP, Cartier R, Pellerin M, Demers P. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):110-5. doi: 10.1093/icvts/ivt123.
PubMed 23575759
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00684125
- Acronym / sponsor ID
- Blake / ICM 07-934
- Keywords
- late cardiac tamponade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 May 2008 (estimated)
- 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.
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. A prospective randomized trial.
Detailed description
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. Patients undergoing aortic and / or valvular surgery will be randomized in two groups. In group A, mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. In group B, mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. In both groups, conventional chest tubes will be removed on the first postoperative day, while patients in the group A will have prolonged drainage using the Blake drain until output is less than 50 ml over 24 hour. Patients will be followed during their postoperative course for occurrence of significant pericardial effusion as detected on routine echocardiogram and late cardiac tamponade requiring reintervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Blake Drains (Blake drain, Ethicon USA)mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. |
| 2 | Active comparator | Device: Standard mediastinal drainagemediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 90 years old, undergoing either surgery of the ascending and/or transverse aorta, or surgery of the mitral and/or aortic valves
- Availability for follow-up at the Montreal Heart Institute Exclusion criteria
Key exclusion criteria (2 listed)
- Emergency surgery
- Unavailability for follow-up at the Montreal Heart Institute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blake Drains (Blake drain, Ethicon USA)Also: Blake drain: prolonged mediastinal drainage19F Blake drain located in the posterior pericardial cavity | Device | 1 |
| Standard mediastinal drainageAlso: mediastinal drainageMediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum | Device | 2 |
Primary outcome
Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention.
Time frame: Day 5 - post surgery
1 secondary outcome
Total volume of mediastinal drainage. Pain intensity on postoperative days 1 to 5. Incidence of postoperative atrial fibrillation Drain-associated infection or any other drain-associated adverse event.
Time frame: Days 1 or till discharge - post surgery
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 22 Jul 2011.
- Background: PubMed 16798298Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049.
- Background: PubMed 16733162Agati S, Mignosa C, Gitto P, Trimarchi ES, Ciccarello G, Salvo D, Trimarchi G. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1306-9. doi: 10.1016/j.jtcvs.2006.02.013.
- Background: PubMed 15539727Ege T, Tatli E, Canbaz S, Cikirikcioglu M, Sunar H, Ozalp B, Duran E. The importance of intrapericardial drain selection in cardiac surgery. Chest. 2004 Nov;126(5):1559-62. doi: 10.1378/chest.126.5.1559.
- Background: PubMed 11016389Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg. 2000 Sep;70(3):1109-10. doi: 10.1016/s0003-4975(00)01800-2.
- Background: PubMed 12400760Kuvin JT, Harati NA, Pandian NG, Bojar RM, Khabbaz KR. Postoperative cardiac tamponade in the modern surgical era. Ann Thorac Surg. 2002 Oct;74(4):1148-53. doi: 10.1016/s0003-4975(02)03837-7.
- Background: PubMed 16928545Shah A, van den Brink A, de Mol B. Raised international normalized ratio: an early warning for a late cardiac tamponade? Ann Thorac Surg. 2006 Sep;82(3):1090-1. doi: 10.1016/j.athoracsur.2006.01.035.
- Derived from this study: PubMed 23575759Moss E, Miller CS, Jensen H, Basmadjian A, Bouchard D, Carrier M, Perrault LP, Cartier R, Pellerin M, Demers P. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):110-5. doi: 10.1093/icvts/ivt123.
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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.
Phillippe Demers, MD principal investigator
Montreal Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blake Drains (Blake drain, Ethicon USA) and Standard mediastinal drainage in people with Pericardial Effusion and Late Cardiac Tamponade, run by Montreal Heart Institute at 1 site in Canada.
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 2 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention. (time frame: Day 5 - post 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 NCT00684125, 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 22 Jul 2011.