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| Name | Class |
|---|---|
| ClearFlow, Inc. | INDUSTRY |
| Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal | OTHER |
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The purpose of this study is to assess the effectiveness of the PleuraFlow® Active Tube Clearance (ATC) technology in reducing the rate of postoperative atrial fibrillation (POAF) among post cardiac surgery patients and to evaluate the impact of Active Tube Clearance (ATC) on other complications, such as retained blood syndrome (RBS), a composite endpoint including re-exploration for bleeding or tamponade, and interventions for hemothorax, pericardial or pleural effusion.
Data will be collected and stored at the department of surgery of Montreal Heart Institute. Only the principal investigator and study coordinators will have access to the database.
The primary analysis will be an intention-to-treat (ITT) analysis comparing the POAF rate in the PleuraFlow® group to the POAF rate in the control group. Based on findings from our institutional clinical database at the Montreal Heart Institute, the local incidence of POAF after cardiac surgery is approximately 25% (control group). The proportion in ATC group (the treatment group) is assumed to be 0,2500 under the null hypothesis and 0,1500 under the alternative hypothesis. Group sample sizes of 254 in each group achieve 80% power to detect a difference between the group proportions of 0,1000 using a Chi-Square test with a significance level of 0.0476. This significance level is computed using the O'Brien-Fleming method and accounts for the interim analysis that is planned after 300 randomized subjects have completed their 30-day follow-up.
POAF and intervention to treat RBS rates and all other categorical event rates will be compared using chi-square tests. Multiple logistic regressions to adjust for potential confounding factors will also be used. Odds ratio and associated 95% confidence intervals will be computed for descriptive purpose. Goodness of fit will be checked using Hosmer-Lemeshow statistics. Quantitative endpoints will be investigated using Student t-tests. Analysis of covariance may also be used to account for potential confounding factors. Nonparametric tests or data transformation may be used if quantitative endpoints are not normally distributed. Correlations and associated 95% confidence intervals will be computed for descriptive purpose. An interim analysis will be conducted on the first 300 randomized subjects completing their 30-day follow-up. The primary endpoint (POAF rate) will be compared between the PleuraFlow® group and the control group using a chi-square test. The significance level for this test will be 0.0076, as computed using the O'Brien-Fleming method. If the p-value of the chi-square test is below this bound at the interim analysis, the study will be stopped for efficacy. Otherwise, the study will continue up to the planned 508 patients. As a result of this interim look, the final analysis of the primary endpoint would require a p < 0.0476 to be declared statistically significant. Analysis of the secondary endpoints and other outcomes will be conducted at the 0.05 significance level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard drainage | Active Comparator | The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. |
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| Active Tube Clearance drainage | Experimental | The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard drainage | Device | One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Atrial Fibrillation | Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode ≥ 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge. | From post index surgery through hospital discharge, an average of 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications) | Any of the following:
| Within 30 days post index surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Being Readmitted | Frequency of readmission for any indication | Within 30 days post index surgery |
| Total Chest Tube Output | Total chest tube output (milliliter) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Demers, MD MSc | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada | ||
| Hôpital du Sacré-Coeur de Montréal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33757537 | Derived | St-Onge S, Chauvette V, Hamad R, Bouchard D, Jeanmart H, Lamarche Y, Perrault LP, Demers P. Active clearance vs conventional management of chest tubes after cardiac surgery: a randomized controlled study. J Cardiothorac Surg. 2021 Mar 23;16(1):44. doi: 10.1186/s13019-021-01414-0. |
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30 patients were excluded after randomization because of the identification of an exclusion criteria
Atrial fibrillation history (n = 10) Transcatheter aortic valve replacement (n = 1) Deep hypothermic arrest (n = 1) Active endocarditis (n = 3) Inherited bleeding disorder (n = 1) Minimally invasive procedure (n = 14)
257 patients were randomized in the Active Tube Clearance (ATC) group for 263 in the standard drainage group prior to early dropouts. Respectively, 241 and 249 patients were followed for the duration of the trial. 100 random patients were included in the direct visual analysis: 57 and 43 in each respective group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Drainage | The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2016 |
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| Active Tube Clearance drainage | Device | One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon. |
|
| Number of Participants Requiring Re-exploration for Bleeding or Tamponade | Rate of re-exploration for bleeding or tamponade within 30-day post index surgery | within 30-day post index surgery |
| Number of Participants Presenting With a Chest Tube Occlusion | Visual observation of mediastinal chest tube lumen upon removal to determine whether it is:
| At chest tube removal |
| Number of Patients Requiring Pericardial Drainage Procedure | Rate of invasive pericardial drainage procedure within 30-day post index surgery | within 30-day post index surgery |
| Number of Patients Requiring Pleural Drainage Procedure | Rate of invasive pleural drainage procedure within 30-day post index surgery | within 30-day post index surgery |
| At chest tube removal |
| Montreal |
| Quebec |
| H4J 1C5 |
| Canada |
| FG001 | Active Tube Clearance Drainage | The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Clearance Technology drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19 Fr chest tubes were left at the discretion of the operating surgeon. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Drainage | The control arm consist of consecutively enrolled cardiac surgery patients receiving one standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (FR) shall be used. Use of silastic 19F chest tubes were left at the discretion of the operating surgeon. |
| BG001 | Active Tube Clearance Drainage | The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Clearance Technology drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 FR shall be used. Use of silastic 19F chest tubes were left at the discretion of the operating surgeon. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Postoperative Atrial Fibrillation | Rate of any episode of new onset of Postoperative Atrial Fibrillation (POAF) in the study group. POAF is defined as any atrial fibrillation episode ≥ 60 min on telemetry or EKG. At any time between post index surgery through hospital discharge. | Posted | Count of Participants | Participants | From post index surgery through hospital discharge, an average of 30 days |
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| Secondary | Number of Participants Requiring Invasive Procedure for Intrathoracic Fluid Removal (Retained Blood Complications) | Any of the following:
| Posted | Count of Participants | Participants | Within 30 days post index surgery |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Requiring Re-exploration for Bleeding or Tamponade | Rate of re-exploration for bleeding or tamponade within 30-day post index surgery | Posted | Count of Participants | Participants | within 30-day post index surgery |
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| Secondary | Number of Participants Presenting With a Chest Tube Occlusion | Visual observation of mediastinal chest tube lumen upon removal to determine whether it is:
| 100 random patients were included in this analysis where the chest tubes were visually inspected upon removal by a blinded investigator. They were selected by convenience, when the investigator was available. | Posted | Count of Participants | Participants | At chest tube removal |
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| Secondary | Number of Patients Requiring Pericardial Drainage Procedure | Rate of invasive pericardial drainage procedure within 30-day post index surgery | Posted | Count of Participants | Participants | within 30-day post index surgery |
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| Secondary | Number of Patients Requiring Pleural Drainage Procedure | Rate of invasive pleural drainage procedure within 30-day post index surgery | Posted | Count of Participants | Participants | within 30-day post index surgery |
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| Other Pre-specified | Number of Patients Being Readmitted | Frequency of readmission for any indication | Posted | Count of Participants | Participants | Within 30 days post index surgery |
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| Other Pre-specified | Total Chest Tube Output | Total chest tube output (milliliter) | Posted | Median | 95% Confidence Interval | milliliters | At chest tube removal |
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within 30-day post index surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Drainage | The control arm consist of consecutively enrolled cardiac surgery patients receiving one (1) standard chest tube in the mediastinum and at most three (3) commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Standard drainage: One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (Fr) shall be used. Use of silastic 19Fr chest tubes were left at the discretion of the operating surgeon. | 4 | 240 | 0 | 240 | 0 | 230 |
| EG001 | Active Tube Clearance Drainage | The test arm consists of consecutively enrolled cardiac surgery patients receiving one (1) chest tube using active tube clearance (PleuraFlow®) in the mediastinum and at most three (3) other commercially available standard or silastic chest tubes in the mediastinal, right or left pleural space. Active Tube Clearance drainage: One (1) PleuraFlow chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 Fr shall be used. Use of silastic 19Fr chest tubes were left at the discretion of the operating surgeon. | 3 | 230 | 0 | 230 | 0 | 240 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philippe Demers | Montreal Heart Institute | 5143763330 | philippe.demers@icm-mhi.org |
| May 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D010490 | Pericardial Effusion |
| D010996 | Pleural Effusion |
| D006491 | Hemothorax |
| D002305 | Cardiac Tamponade |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
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