Trial Outcomes & Findings for Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation (NCT NCT04130061)
NCT ID: NCT04130061
Last Updated: 2026-04-09
Results Overview
Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
27 participants
Primary outcome timeframe
72 hours
Results posted on
2026-04-09
Participant Flow
Recruitment in a University hospital (inpatient, outpatient clinics) from October 2019 through May 2021
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.
Participant milestones
| Measure |
Randomized
Patients undergoing isolated CABG who randomized to receive amniotic membrane
|
Control
Patients undergoing isolated CABG who randomized to receive standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Randomized
Patients undergoing isolated CABG who randomized to receive amniotic membrane
|
Control
Patients undergoing isolated CABG who randomized to receive standard of care
|
|---|---|---|
|
Overall Study
OR team forgot to request membrane
|
1
|
0
|
Baseline Characteristics
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=36 Participants
|
8 Participants
n=78 Participants
|
14 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=36 Participants
|
6 Participants
n=78 Participants
|
12 Participants
n=23 Participants
|
|
Age, Continuous
|
64.91 years
n=36 Participants
|
65.78 years
n=78 Participants
|
65.38 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=36 Participants
|
4 Participants
n=78 Participants
|
6 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=36 Participants
|
10 Participants
n=78 Participants
|
20 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=36 Participants
|
1 Participants
n=78 Participants
|
3 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=36 Participants
|
13 Participants
n=78 Participants
|
23 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=36 Participants
|
13 Participants
n=78 Participants
|
24 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=36 Participants
|
1 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=36 Participants
|
14 participants
n=78 Participants
|
26 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 1 monthThe 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).
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 monthThe 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.
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: SurgeryComparison of serum levels of proBNP between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Serum) Between Groups at Time of Surgery
|
347 pg/mL
Standard Deviation 523
|
198 pg/mL
Standard Deviation 263
|
PRIMARY outcome
Timeframe: SurgeryComparison of serum levels of CRP between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Serum) Between Groups at Time of Surgery
|
0.39 mg/dL
Standard Deviation 0.87
|
0.34 mg/dL
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: SurgeryComparison of serum measurement of IL-6 between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Serum) Between Groups at Time of Surgery
|
2.23 pg/mL
Standard Deviation 0.83
|
2.25 pg/mL
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: SurgeryComparison of serum levels of TNFa between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery
|
3.63 pg/mL
Standard Deviation 3.04
|
2.45 pg/mL
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: 24 hoursComparison of serum proBNP levels between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Serum) Between Groups at 24 Hours Post-op
|
2239.42 pg/mL
Standard Deviation 2384.3
|
1922.83 pg/mL
Standard Deviation 1017.9
|
PRIMARY outcome
Timeframe: 24 hoursComparison of serum measurements of CRP between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Serum) Between Groups at 24-hours Post-op
|
10.66 mg/dL
Standard Deviation 4.58
|
14.94 mg/dL
Standard Deviation 5.94
|
PRIMARY outcome
Timeframe: 24 hoursComparison of IL-6 serum levels between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Serum) Between Groups at 24-hours Post-op
|
18.28 pg/mL
Standard Deviation 12.03
|
26.95 pg/mL
Standard Deviation 22.36
|
PRIMARY outcome
Timeframe: 24 hoursComparison of serum levels of TNFa between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op
|
2.87 pg/mL
Standard Deviation 2.72
|
2.61 pg/mL
Standard Deviation 1.22
|
PRIMARY outcome
Timeframe: 48 hoursComparison of serum levels of proBNP between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Serum) Between Groups at 48 Hours Post-op
|
7750.35 pg/mL
Standard Deviation 7474.25
|
6081.83 pg/mL
Standard Deviation 5134.12
|
PRIMARY outcome
Timeframe: 48 hoursComparison of serum CRP levels between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op
|
15.71 mg/dL
Standard Deviation 6.97
|
21.67 mg/dL
Standard Deviation 8.18
|
PRIMARY outcome
Timeframe: 48 hoursComparison of IL-6 serum results between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op
|
14.39 pg/mL
Standard Deviation 10.23
|
12.32 pg/mL
Standard Deviation 10.01
|
PRIMARY outcome
Timeframe: 48 hoursComparison of serum TNFa levels between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op
|
2.27 pg/mL
Standard Deviation 1.09
|
2.34 pg/mL
Standard Deviation 1.51
|
PRIMARY outcome
Timeframe: 72 hoursComparison of serum levels of proBNP between groups at 72 hour post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Serum) Between Groups at 72 Hours Post-op
|
449.71 pg/mL
Standard Deviation 6191.8
|
2707.75 pg/mL
Standard Deviation 925.9
|
PRIMARY outcome
Timeframe: 72 hoursComparison of serum levels of CRP between groups at 72 hour post-op
Outcome measures
| Measure |
Control
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=9 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
CRP (Serum) Between Groups at 72 Hours Post-op
|
14.21 mg/dL
Standard Deviation 5.19
|
17.45 mg/dL
Standard Deviation 5.95
|
PRIMARY outcome
Timeframe: 72 hoursComparison of IL-6 serum levels between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=9 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op
|
10.38 pg/mL
Standard Deviation 8.85
|
5.81 pg/mL
Standard Deviation 4.15
|
PRIMARY outcome
Timeframe: 72 hoursComparison of TNFa serum levels between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=9 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
TNFa (Serum) Between Groups at 72 Hours Post-op
|
2.38 pg/mL
Standard Deviation 1.56
|
2.12 pg/mL
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: 1 monthComparison of serum levels of proBNP between groups at follow-up
Outcome measures
| Measure |
Control
n=10 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Serum) Between Groups at Follow-up
|
1391.7 pg/mL
Standard Deviation 1336.8
|
847 pg/mL
Standard Deviation 505.79
|
PRIMARY outcome
Timeframe: 1 monthComparison of serum CRP levels between groups at follow-up
Outcome measures
| Measure |
Control
n=10 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
CRP (Serum) Between Groups at Follow-Up
|
1.96 mg/dL
Standard Deviation 3.61
|
0.975 mg/dL
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: 1 monthComparison of IL-6 serum levels between groups at follow-up
Outcome measures
| Measure |
Control
n=10 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Serum) Between Groups at Follow-up
|
6.86 pg/mL
Standard Deviation 15.36
|
2.37 pg/mL
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: 1 monthComparison of TNFa serum levels between groups at follow-up
Outcome measures
| Measure |
Control
n=10 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
TNFa (Serum) Between Groups at Follow-up
|
3.11 pg/mL
Standard Deviation 2.93
|
2.11 pg/mL
Standard Deviation 1.16
|
PRIMARY outcome
Timeframe: SurgeryComparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Pericardial Fluid) Between Groups at Time of Surgery
|
1771.07 pg/mL
Standard Deviation 2332.54
|
1039.6 pg/mL
Standard Deviation 819.58
|
PRIMARY outcome
Timeframe: SurgeryComparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery
|
0.39 mg/dL
Standard Deviation 0.87
|
0.34 mg/dL
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: SurgeryComparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery
|
59.9 pg/mL
Standard Deviation 122.83
|
30.3 pg/mL
Standard Deviation 26.17
|
PRIMARY outcome
Timeframe: SurgeryComparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery
|
2.77 pg/mL
Standard Deviation 2.46
|
2.81 pg/mL
Standard Deviation 2.72
|
PRIMARY outcome
Timeframe: 24 hoursComparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op
|
7750.35 pg/mL
Standard Deviation 7474.25
|
6081.83 pg/mL
Standard Deviation 5134.12
|
PRIMARY outcome
Timeframe: 24 hoursComparison of CRP levels in pericardial fluid between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op
|
2.84 mg/dL
Standard Deviation 2.05
|
4.54 mg/dL
Standard Deviation 2.51
|
PRIMARY outcome
Timeframe: 24 hoursComparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op
Outcome measures
| Measure |
Control
n=7 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=4 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op
|
67217.8 pg/mL
Standard Deviation 48407.4
|
88823.8 pg/mL
Standard Deviation 51901.4
|
PRIMARY outcome
Timeframe: 24 hoursComparison of TNFa in pericardial fluid between groups at 24 hours post-op.
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op
|
10.35 pg/mL
Standard Deviation 8.04
|
8.58 pg/mL
Standard Deviation 5.61
|
PRIMARY outcome
Timeframe: 48 hoursComparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op
|
10027.57 pg/mL
Standard Deviation 7189.94
|
8823.4 pg/mL
Standard Deviation 9286.9
|
PRIMARY outcome
Timeframe: 48 hoursComparison of CRP levels in pericardial fluid between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=14 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op
|
4.9 mg/dL
Standard Deviation 2.52
|
6.8 mg/dL
Standard Deviation 3.72
|
PRIMARY outcome
Timeframe: 48 hoursComparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=9 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=5 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op
|
45839.95 pg/mL
Standard Deviation 43229.37
|
64370.14 pg/mL
Standard Deviation 57497
|
PRIMARY outcome
Timeframe: 48 hoursComparison of TNFa levels in pericardial fluid between groups at 48 hours post-op
Outcome measures
| Measure |
Control
n=13 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=12 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op
|
8.03 pg/mL
Standard Deviation 5.34
|
8.3 pg/mL
Standard Deviation 7.81
|
PRIMARY outcome
Timeframe: 72 hoursComparison of proBNP levels in pericardial fluid between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op
|
8423 pg/mL
Standard Deviation 5911.3
|
3895.5 pg/mL
Standard Deviation 1458.8
|
PRIMARY outcome
Timeframe: 72 hoursComparison of CRP levels in pericardial fluid between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=11 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op
|
6.35 mg/dL
Standard Deviation 3.1
|
8.53 mg/dL
Standard Deviation 3.89
|
PRIMARY outcome
Timeframe: 72 hoursComparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=8 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=3 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op
|
25316.6 pg/mL
Standard Deviation 39863.65
|
9296.6 pg/mL
Standard Deviation 9514
|
PRIMARY outcome
Timeframe: 72 hoursComparison of TNFa levels in pericardial fluid between groups at 72 hours post-op
Outcome measures
| Measure |
Control
n=10 Participants
Patients undergoing isolated CABG surgery who are randomized to receive standard of care
|
Randomized
n=7 Participants
Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane
|
|---|---|---|
|
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op
|
8.38 pg/mL
Standard Deviation 4.41
|
12.32 pg/mL
Standard Deviation 13.44
|
Adverse Events
Randomized
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place