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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002538 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Amniotic Membrane | Biological | Epicardial application of human amniotic membrane during cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies). | 1 month |
| Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls | The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate. | 1 month |
| proBNP (Serum) Between Groups at Time of Surgery | Comparison of serum levels of proBNP between groups at the time of surgery (baseline). | Surgery |
| C-reactive Protein (Serum) Between Groups at Time of Surgery | Comparison of serum levels of CRP between groups at the time of surgery (baseline). | Surgery |
| Interleukin-6 (Serum) Between Groups at Time of Surgery | Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline). | Surgery |
| Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery | Comparison of serum levels of TNFa between groups at the time of surgery (baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikas Sharma, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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One participant was enrolled and randomized to receive the intervention, but they ultimately did not have the membrane placed due to a miscommunication in the OR. This is the reason that 27 participants were enrolled but the total number for analysis was 26.
Recruitment in a University hospital (inpatient, outpatient clinics) from October 2019 through May 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized | Patients undergoing isolated CABG who randomized to receive amniotic membrane |
| FG001 | Control | Patients undergoing isolated CABG who randomized to receive standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized | Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane |
| BG001 | Control | Patients undergoing isolated CABG surgery who are randomized to receive standard of care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Adverse Events | The AM applied epicardially will be assessed for signs of hyperacute rejection i.e. membrane changing color; cardiac tamponade or constriction assessed by echocardiogram and transmission of infectious diseases. The incidence of adverse events (AEs) will be reported as percentages, with two-sided 95% confidence intervals. Statistical comparisons of AEs between the AM treatment and the control group will be made using a chi-square, or Fisher's exact test, as appropriate (based on the minimum expected cell frequencies). | Posted | Count of Participants | Participants | 1 month |
|
30 days post-hospital discharge
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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 | Randomized | Patients undergoing isolated CABG who randomized to receive amniotic membrane |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikas Sharma, MD | University of Utah | 801-581-5311 | vikas.sharma@hsc.utah.edu |
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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 | Mar 1, 2021 | May 9, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Surgery |
| proBNP (Serum) Between Groups at 24 Hours Post-op | Comparison of serum proBNP levels between groups at 24 hours post-op | 24 hours |
| C-reactive Protein (Serum) Between Groups at 24-hours Post-op | Comparison of serum measurements of CRP between groups at 24 hours post-op | 24 hours |
| Interleukin-6 (Serum) Between Groups at 24-hours Post-op | Comparison of IL-6 serum levels between groups at 24 hours post-op | 24 hours |
| Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op | Comparison of serum levels of TNFa between groups at 24 hours post-op | 24 hours |
| proBNP (Serum) Between Groups at 48 Hours Post-op | Comparison of serum levels of proBNP between groups at 48 hours post-op | 48 hours |
| C-reactive Protein (Serum) Between Groups at 48 Hours Post-op | Comparison of serum CRP levels between groups at 48 hours post-op | 48 hours |
| Interleukin-6 (Serum) Between Groups at 48 Hours Post-op | Comparison of IL-6 serum results between groups at 48 hours post-op | 48 hours |
| Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op | Comparison of serum TNFa levels between groups at 48 hours post-op | 48 hours |
| proBNP (Serum) Between Groups at 72 Hours Post-op | Comparison of serum levels of proBNP between groups at 72 hour post-op | 72 hours |
| CRP (Serum) Between Groups at 72 Hours Post-op | Comparison of serum levels of CRP between groups at 72 hour post-op | 72 hours |
| Interleukin-6 (Serum) Between Groups at 72 Hours Post-op | Comparison of IL-6 serum levels between groups at 72 hours post-op | 72 hours |
| TNFa (Serum) Between Groups at 72 Hours Post-op | Comparison of TNFa serum levels between groups at 72 hours post-op | 72 hours |
| proBNP (Serum) Between Groups at Follow-up | Comparison of serum levels of proBNP between groups at follow-up | 1 month |
| CRP (Serum) Between Groups at Follow-Up | Comparison of serum CRP levels between groups at follow-up | 1 month |
| Interleukin-6 (Serum) Between Groups at Follow-up | Comparison of IL-6 serum levels between groups at follow-up | 1 month |
| TNFa (Serum) Between Groups at Follow-up | Comparison of TNFa serum levels between groups at follow-up | 1 month |
| proBNP (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline) | Surgery |
| C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline). | Surgery |
| Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline). | Surgery |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline). | Surgery |
| proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op | 24 hours |
| C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op | 24 hours |
| Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op | 24 hours |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of TNFa in pericardial fluid between groups at 24 hours post-op. | 24 hours |
| proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op. | 48 hours |
| C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op | 48 hours |
| Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op | 48 hours |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op | 48 hours |
| proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op | 72 hours |
| C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op | 72 hours |
| Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op | 72 hours |
| Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op | 72 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients undergoing isolated CABG surgery who are randomized to receive standard of care |
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| Primary | Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls | The number of patients with Post Op Atrial Fibrillation will be compared between the treatment and control group using mobile telemetry. This comparison will be analyzed using chi-square or Fisher's exact test as appropriate. | Posted | Count of Participants | Participants | 1 month |
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| Primary | proBNP (Serum) Between Groups at Time of Surgery | Comparison of serum levels of proBNP between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | pg/mL | Surgery |
|
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| Primary | C-reactive Protein (Serum) Between Groups at Time of Surgery | Comparison of serum levels of CRP between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | mg/dL | Surgery |
|
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| Primary | Interleukin-6 (Serum) Between Groups at Time of Surgery | Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | pg/mL | Surgery |
|
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| Primary | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery | Comparison of serum levels of TNFa between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | pg/mL | Surgery |
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| Primary | proBNP (Serum) Between Groups at 24 Hours Post-op | Comparison of serum proBNP levels between groups at 24 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
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| Primary | C-reactive Protein (Serum) Between Groups at 24-hours Post-op | Comparison of serum measurements of CRP between groups at 24 hours post-op | Posted | Mean | Standard Deviation | mg/dL | 24 hours |
|
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| Primary | Interleukin-6 (Serum) Between Groups at 24-hours Post-op | Comparison of IL-6 serum levels between groups at 24 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
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| Primary | Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op | Comparison of serum levels of TNFa between groups at 24 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
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| Primary | proBNP (Serum) Between Groups at 48 Hours Post-op | Comparison of serum levels of proBNP between groups at 48 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
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| Primary | C-reactive Protein (Serum) Between Groups at 48 Hours Post-op | Comparison of serum CRP levels between groups at 48 hours post-op | Posted | Mean | Standard Deviation | mg/dL | 48 hours |
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| Primary | Interleukin-6 (Serum) Between Groups at 48 Hours Post-op | Comparison of IL-6 serum results between groups at 48 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
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| Primary | Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op | Comparison of serum TNFa levels between groups at 48 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
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| Primary | proBNP (Serum) Between Groups at 72 Hours Post-op | Comparison of serum levels of proBNP between groups at 72 hour post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Primary | CRP (Serum) Between Groups at 72 Hours Post-op | Comparison of serum levels of CRP between groups at 72 hour post-op | Posted | Mean | Standard Deviation | mg/dL | 72 hours |
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| Primary | Interleukin-6 (Serum) Between Groups at 72 Hours Post-op | Comparison of IL-6 serum levels between groups at 72 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Primary | TNFa (Serum) Between Groups at 72 Hours Post-op | Comparison of TNFa serum levels between groups at 72 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Primary | proBNP (Serum) Between Groups at Follow-up | Comparison of serum levels of proBNP between groups at follow-up | Posted | Mean | Standard Deviation | pg/mL | 1 month |
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| Primary | CRP (Serum) Between Groups at Follow-Up | Comparison of serum CRP levels between groups at follow-up | Posted | Mean | Standard Deviation | mg/dL | 1 month |
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| Primary | Interleukin-6 (Serum) Between Groups at Follow-up | Comparison of IL-6 serum levels between groups at follow-up | Posted | Mean | Standard Deviation | pg/mL | 1 month |
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| Primary | TNFa (Serum) Between Groups at Follow-up | Comparison of TNFa serum levels between groups at follow-up | Posted | Mean | Standard Deviation | pg/mL | 1 month |
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| Primary | proBNP (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline) | Posted | Mean | Standard Deviation | pg/mL | Surgery |
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| Primary | C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | mg/dL | Surgery |
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| Primary | Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | pg/mL | Surgery |
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| Primary | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery | Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline). | Posted | Mean | Standard Deviation | pg/mL | Surgery |
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| Primary | proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
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| Primary | C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op | Posted | Mean | Standard Deviation | mg/dL | 24 hours |
|
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| Primary | Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
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| Primary | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op | Comparison of TNFa in pericardial fluid between groups at 24 hours post-op. | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
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| Primary | proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op. | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
|
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| Primary | C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op | Posted | Mean | Standard Deviation | mg/dL | 48 hours |
|
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| Primary | Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
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| Primary | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op | Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 48 hours |
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| Primary | proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Primary | C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op | Posted | Mean | Standard Deviation | mg/dL | 72 hours |
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| Primary | Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
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| Primary | Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op | Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op | Posted | Mean | Standard Deviation | pg/mL | 72 hours |
|
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Patients undergoing isolated CABG who randomized to receive standard of care | 0 | 14 | 0 | 14 | 0 | 14 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |