Trial Outcomes & Findings for Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation (NCT NCT04130061)

NCT ID: NCT04130061

Last Updated: 2024-12-06

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 27 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2024-12-06

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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	64.91 years n=5 Participants	65.78 years n=7 Participants	65.38 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	14 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

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).

Outcome measures

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
Number of Participants With Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 month

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.

Outcome measures

Measure	Randomized n=13 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
Number of Participants With Post Op Atrial Fibrillation Between Patients Who Receive hAM and Controls	5 Participants	6 Participants

PRIMARY outcome

Timeframe: Surgery

Comparison of serum levels of proBNP between groups at the time of surgery (baseline).

Outcome measures

Measure	Randomized n=12 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
proBNP (Serum) Between Groups at Time of Surgery	198 pg/mL Standard Deviation 263	347 pg/mL Standard Deviation 523

PRIMARY outcome

Timeframe: Surgery

Comparison of serum levels of CRP between groups at the time of surgery (baseline).

Outcome measures

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
C-reactive Protein (Serum) Between Groups at Time of Surgery	0.34 mg/dL Standard Deviation 0.32	0.39 mg/dL Standard Deviation 0.87

PRIMARY outcome

Timeframe: Surgery

Comparison of serum measurement of IL-6 between groups at the time of surgery (baseline).

Outcome measures

Measure	Randomized n=12 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Serum) Between Groups at Time of Surgery	2.25 pg/mL Standard Deviation 0.86	2.23 pg/mL Standard Deviation 0.83

PRIMARY outcome

Timeframe: Surgery

Comparison of serum levels of TNFa between groups at the time of surgery (baseline).

Outcome measures

Measure	Randomized n=12 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at Time of Surgery	2.45 pg/mL Standard Deviation 1.56	3.63 pg/mL Standard Deviation 3.04

PRIMARY outcome

Timeframe: 24 hours

Comparison of serum proBNP levels between groups at 24 hours post-op

Outcome measures

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
proBNP (Serum) Between Groups at 24 Hours Post-op	1922.83 pg/mL Standard Deviation 1017.9	2239.42 pg/mL Standard Deviation 2384.3

PRIMARY outcome

Timeframe: 24 hours

Comparison of serum measurements of CRP between groups at 24 hours post-op

Outcome measures

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
C-reactive Protein (Serum) Between Groups at 24-hours Post-op	14.94 mg/dL Standard Deviation 5.94	10.66 mg/dL Standard Deviation 4.58

PRIMARY outcome

Timeframe: 24 hours

Comparison of IL-6 serum levels between groups at 24 hours post-op

Outcome measures

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
Interleukin-6 (Serum) Between Groups at 24-hours Post-op	26.95 pg/mL Standard Deviation 22.36	18.28 pg/mL Standard Deviation 12.03

PRIMARY outcome

Timeframe: 24 hours

Comparison of serum levels of TNFa between groups at 24 hours post-op

Outcome measures

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
Tumor Necrosis Factor - Alpha (TNFa; Serum) Between Groups at 24 Hours Post-op	2.61 pg/mL Standard Deviation 1.22	2.87 pg/mL Standard Deviation 2.72

PRIMARY outcome

Timeframe: 48 hours

Comparison of serum levels of proBNP between groups at 48 hours post-op

Outcome measures

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
proBNP (Serum) Between Groups at 48 Hours Post-op	6081.83 pg/mL Standard Deviation 5134.12	7750.35 pg/mL Standard Deviation 7474.25

PRIMARY outcome

Timeframe: 48 hours

Comparison of serum CRP levels between groups at 48 hours post-op

Outcome measures

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
C-reactive Protein (Serum) Between Groups at 48 Hours Post-op	21.67 mg/dL Standard Deviation 8.18	15.71 mg/dL Standard Deviation 6.97

PRIMARY outcome

Timeframe: 48 hours

Comparison of IL-6 serum results between groups at 48 hours post-op

Outcome measures

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
Interleukin-6 (Serum) Between Groups at 48 Hours Post-op	12.32 pg/mL Standard Deviation 10.01	14.39 pg/mL Standard Deviation 10.23

PRIMARY outcome

Timeframe: 48 hours

Comparison of serum TNFa levels between groups at 48 hours post-op

Outcome measures

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
Tumor Necrosis Factor - Alpha (Serum) Between Groups at 48 Hours Post-op	2.34 pg/mL Standard Deviation 1.51	2.27 pg/mL Standard Deviation 1.09

PRIMARY outcome

Timeframe: 72 hours

Comparison of serum levels of proBNP between groups at 72 hour post-op

Outcome measures

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
proBNP (Serum) Between Groups at 72 Hours Post-op	2707.75 pg/mL Standard Deviation 925.9	449.71 pg/mL Standard Deviation 6191.8

PRIMARY outcome

Timeframe: 72 hours

Comparison of serum levels of CRP between groups at 72 hour post-op

Outcome measures

Measure	Randomized n=9 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
CRP (Serum) Between Groups at 72 Hours Post-op	17.45 mg/dL Standard Deviation 5.95	14.21 mg/dL Standard Deviation 5.19

PRIMARY outcome

Timeframe: 72 hours

Comparison of IL-6 serum levels between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=9 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Serum) Between Groups at 72 Hours Post-op	5.81 pg/mL Standard Deviation 4.15	10.38 pg/mL Standard Deviation 8.85

PRIMARY outcome

Timeframe: 72 hours

Comparison of TNFa serum levels between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=9 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
TNFa (Serum) Between Groups at 72 Hours Post-op	2.12 pg/mL Standard Deviation 1.26	2.38 pg/mL Standard Deviation 1.56

PRIMARY outcome

Timeframe: 1 month

Comparison of serum levels of proBNP between groups at follow-up

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=10 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
proBNP (Serum) Between Groups at Follow-up	847 pg/mL Standard Deviation 505.79	1391.7 pg/mL Standard Deviation 1336.8

PRIMARY outcome

Timeframe: 1 month

Comparison of serum CRP levels between groups at follow-up

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=10 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
CRP (Serum) Between Groups at Follow-Up	0.975 mg/dL Standard Deviation 0.49	1.96 mg/dL Standard Deviation 3.61

PRIMARY outcome

Timeframe: 1 month

Comparison of IL-6 serum levels between groups at follow-up

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=10 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Serum) Between Groups at Follow-up	2.37 pg/mL Standard Deviation 1.06	6.86 pg/mL Standard Deviation 15.36

PRIMARY outcome

Timeframe: 1 month

Comparison of TNFa serum levels between groups at follow-up

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=10 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
TNFa (Serum) Between Groups at Follow-up	2.11 pg/mL Standard Deviation 1.16	3.11 pg/mL Standard Deviation 2.93

PRIMARY outcome

Timeframe: Surgery

Comparison of proBNP levels in pericardial fluid between groups at time of surgery (baseline)

Outcome measures

Measure	Randomized n=13 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
proBNP (Pericardial Fluid) Between Groups at Time of Surgery	1039.6 pg/mL Standard Deviation 819.58	1771.07 pg/mL Standard Deviation 2332.54

PRIMARY outcome

Timeframe: Surgery

Comparison of CRP levels in pericardial fluid between groups at the time of surgery (baseline).

Outcome measures

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
C-reactive Protein (Pericardial Fluid) Between Groups at Time of Surgery	0.34 mg/dL Standard Deviation 0.32	0.39 mg/dL Standard Deviation 0.87

PRIMARY outcome

Timeframe: Surgery

Comparison of IL-6 levels in pericardial fluid between groups at the time of surgery (baseline).

Outcome measures

Measure	Randomized n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Pericardial Fluid) Between Groups at Time of Surgery	30.3 pg/mL Standard Deviation 26.17	59.9 pg/mL Standard Deviation 122.83

PRIMARY outcome

Timeframe: Surgery

Comparison of TNFa in pericardial fluid between groups at the time of surgery (baseline).

Outcome measures

Measure	Randomized n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at Time of Surgery	2.81 pg/mL Standard Deviation 2.72	2.77 pg/mL Standard Deviation 2.46

PRIMARY outcome

Timeframe: 24 hours

Comparison of levels of proBNP in pericardial fluid between groups at 24 hours post-op

Outcome measures

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
proBNP (Pericardial Fluid) Between Groups at 24 Hours Post-op	6081.83 pg/mL Standard Deviation 5134.12	7750.35 pg/mL Standard Deviation 7474.25

PRIMARY outcome

Timeframe: 24 hours

Comparison of CRP levels in pericardial fluid between groups at 24 hours post-op

Outcome measures

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
C-reactive Protein (Pericardial Fluid) Between Groups at 24 Hours Post-op	4.54 mg/dL Standard Deviation 2.51	2.84 mg/dL Standard Deviation 2.05

PRIMARY outcome

Timeframe: 24 hours

Comparison of IL-6 levels in pericardial fluid between groups at 24 hours post-op

Outcome measures

Measure	Randomized n=4 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=7 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Pericardial Fluid) Between Groups at 24 Hours Post-op	88823.8 pg/mL Standard Deviation 51901.4	67217.8 pg/mL Standard Deviation 48407.4

PRIMARY outcome

Timeframe: 24 hours

Comparison of TNFa in pericardial fluid between groups at 24 hours post-op.

Outcome measures

Measure	Randomized n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 24 Hours Post-op	8.58 pg/mL Standard Deviation 5.61	10.35 pg/mL Standard Deviation 8.04

PRIMARY outcome

Timeframe: 48 hours

Comparison of proBNP levels in pericardial fluid between groups at 48 hours post-op.

Outcome measures

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
proBNP (Pericardial Fluid) Between Groups at 48 Hours Post-op	8823.4 pg/mL Standard Deviation 9286.9	10027.57 pg/mL Standard Deviation 7189.94

PRIMARY outcome

Timeframe: 48 hours

Comparison of CRP levels in pericardial fluid between groups at 48 hours post-op

Outcome measures

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
C-reactive Protein (Pericardial Fluid) Between Groups at 48 Hours Post-op	6.8 mg/dL Standard Deviation 3.72	4.9 mg/dL Standard Deviation 2.52

PRIMARY outcome

Timeframe: 48 hours

Comparison of IL-6 levels in pericardial fluid between groups at 48 hours post-op

Outcome measures

Measure	Randomized n=5 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=9 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Pericardial Fluid) Between Groups at 48 Hours Post-op	64370.14 pg/mL Standard Deviation 57497	45839.95 pg/mL Standard Deviation 43229.37

PRIMARY outcome

Timeframe: 48 hours

Comparison of TNFa levels in pericardial fluid between groups at 48 hours post-op

Outcome measures

Measure	Randomized n=12 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=13 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 48 Hours Post-op	8.3 pg/mL Standard Deviation 7.81	8.03 pg/mL Standard Deviation 5.34

PRIMARY outcome

Timeframe: 72 hours

Comparison of proBNP levels in pericardial fluid between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
proBNP (Pericardial Fluid) Between Groups at 72 Hours Post-op	3895.5 pg/mL Standard Deviation 1458.8	8423 pg/mL Standard Deviation 5911.3

PRIMARY outcome

Timeframe: 72 hours

Comparison of CRP levels in pericardial fluid between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=11 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
C-reactive Protein (Pericardial Fluid) Between Groups at 72 Hours Post-op	8.53 mg/dL Standard Deviation 3.89	6.35 mg/dL Standard Deviation 3.1

PRIMARY outcome

Timeframe: 72 hours

Comparison of IL-6 levels in pericardial fluid between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=3 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=8 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Interleukin-6 (Pericardial Fluid) Between Groups at 72 Hours Post-op	9296.6 pg/mL Standard Deviation 9514	25316.6 pg/mL Standard Deviation 39863.65

PRIMARY outcome

Timeframe: 72 hours

Comparison of TNFa levels in pericardial fluid between groups at 72 hours post-op

Outcome measures

Measure	Randomized n=7 Participants Patients undergoing isolated CABG surgery who are randomized to receive amniotic membrane	Control n=10 Participants Patients undergoing isolated CABG surgery who are randomized to receive standard of care
Tumor Necrosis Factor - Alpha (Pericardial Fluid) Between Groups at 72 Hours Post-op	12.32 pg/mL Standard Deviation 13.44	8.38 pg/mL Standard Deviation 4.41

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

Vikas Sharma, MD

University of Utah

Phone: 801-581-5311

Email: vikas.sharma@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place