Trial Outcomes & Findings for Anesthetics to Prevent Lung Injury in Cardiac Surgery (NCT NCT02918877)
NCT ID: NCT02918877
Last Updated: 2021-05-05
Results Overview
Inflammatory mediator found in BAL fluid during lung inflammation
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Change from baseline and 2-4 hours after exposure to cardiopulmonary bypass
Results posted on
2021-05-05
Participant Flow
51 Enrolled
49 Randomized * Withdrew consent (1) * Surgery cancelled (1)
Participant milestones
| Measure |
Inhaled Anesthesia
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Inhaled Anesthesia
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Surgery cancelled
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Received intraoperative steroids
|
1
|
0
|
|
Overall Study
Unable to obtain lab samples
|
1
|
0
|
|
Overall Study
Unsafe to perform BAL
|
0
|
1
|
Baseline Characteristics
Anesthetics to Prevent Lung Injury in Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Comorbidities
Chronic Obstructive Pulmonary Disease/Asthma
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
64.6 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Weight
|
207.82 Pounds
STANDARD_DEVIATION 39.60 • n=5 Participants
|
194.10 Pounds
STANDARD_DEVIATION 42.54 • n=7 Participants
|
200.96 Pounds
STANDARD_DEVIATION 41.07 • n=5 Participants
|
|
Height
|
69.11 Inches
STANDARD_DEVIATION 3.65 • n=5 Participants
|
68.41 Inches
STANDARD_DEVIATION 3.49 • n=7 Participants
|
68.76 Inches
STANDARD_DEVIATION 3.57 • n=5 Participants
|
|
Body Mass Index
|
31.20 kg/m^2
STANDARD_DEVIATION 4.34 • n=5 Participants
|
29.61 kg/m^2
STANDARD_DEVIATION 5.02 • n=7 Participants
|
30.41 kg/m^2
STANDARD_DEVIATION 4.68 • n=5 Participants
|
|
Comorbidities
Hypertension
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Comorbidities
Hyperlipidemia
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Comorbidities
Congestive Heart Failure
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Comorbidities
Arrhythmia
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Comorbidities
Obesity
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Comorbidities
Diabetes without Complications
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Comorbidities
Diabetes with End Organ Damage
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Comorbidities
Moderate or Severe Renal Disease
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Comorbidities
Solid (Non-Metastatic) Tumor
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
ASA Score (American Society of Anesthesiologists)
|
3.67 scores on a scale.
STANDARD_DEVIATION 0.48 • n=5 Participants
|
3.82 scores on a scale.
STANDARD_DEVIATION 0.39 • n=7 Participants
|
3.75 scores on a scale.
STANDARD_DEVIATION 0.44 • n=5 Participants
|
|
ARISCAT Score
|
50.28 scores on a scale
STANDARD_DEVIATION 10.20 • n=5 Participants
|
47.86 scores on a scale
STANDARD_DEVIATION 8.15 • n=7 Participants
|
49.07 scores on a scale
STANDARD_DEVIATION 9.18 • n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassInflammatory mediator found in BAL fluid during lung inflammation
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Pre-Bypass
|
0.53 pg/mL
Interval 0.53 to 4.99
|
0.53 pg/mL
Interval 0.53 to 13.8
|
|
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Post-Bypass
|
22.06 pg/mL
Interval 1.75 to 623.08
|
102.04 pg/mL
Interval 2.21 to 408.05
|
|
Bronchoalveolar Lavage (BAL) Concentration of TNF Alpha (pg/mL)
Difference
|
17.24 pg/mL
Interval 1.22 to 536.77
|
101.51 pg/mL
Interval 1.47 to 402.84
|
SECONDARY outcome
Timeframe: Assessed daily, beginning on the first day after surgery, until hospital discharge or death. On average at our institution, most patients are discharged within 7 days so this is the expected time frame for follow up.Composite endpoint of clinically relevant pulmonary complications
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
Number of Patients With Postoperative Pulmonary Complications
Prolonged intubation (greater than 48hrs)
|
0 Participants
|
3 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Failed extubation (re-intubated within 24hrs)
|
0 Participants
|
1 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Reintubation (greater than 24hrs after extubation)
|
0 Participants
|
2 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Pulmonary edema
|
4 Participants
|
8 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Pleural effusion
|
17 Participants
|
21 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Atelectasis
|
16 Participants
|
19 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Infiltrate/consolidation
|
6 Participants
|
6 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Pneumothorax
|
1 Participants
|
5 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
ARDS
|
0 Participants
|
0 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Pneumonia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Brochospasm
|
1 Participants
|
1 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Exacerbation of chronic lung disease
|
0 Participants
|
0 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Hypoxia (PaO2/FiO2 < 300)
|
16 Participants
|
15 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Respiratory acidosis (PaCO2 > 45)
|
12 Participants
|
15 Participants
|
|
Number of Patients With Postoperative Pulmonary Complications
Any postoperative pulmonary complication
|
18 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassInflammatory mediator found in BAL fluid during lung inflammation
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
BAL Concentration of IL1b (pg/mL)
Pre-Bypass
|
0.42 pg/mL
Interval 0.06 to 2.61
|
0.87 pg/mL
Interval 0.28 to 2.54
|
|
BAL Concentration of IL1b (pg/mL)
Post-Bypass
|
8.56 pg/mL
Interval 0.21 to 64.77
|
14.37 pg/mL
Interval 1.88 to 76.1
|
|
BAL Concentration of IL1b (pg/mL)
Difference
|
8.30 pg/mL
Interval -0.67 to 59.64
|
11.00 pg/mL
Interval 1.18 to 66.14
|
SECONDARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassInflammatory mediator found in BAL fluid during lung inflammation
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
BAL Concentration of IL6 (pg/mL)
Pre-Bypass
|
30.70 pg/mL
Interval 6.77 to 96.6
|
31.35 pg/mL
Interval 5.27 to 165.93
|
|
BAL Concentration of IL6 (pg/mL)
Post-Bypass
|
275.19 pg/mL
Interval 6.21 to 1134.33
|
297.35 pg/mL
Interval 40.59 to 1277.04
|
|
BAL Concentration of IL6 (pg/mL)
Difference
|
220.68 pg/mL
Interval -12.41 to 1046.0
|
259.32 pg/mL
Interval 30.33 to 1039.58
|
SECONDARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassInflammatory mediator found in BAL fluid during lung inflammation
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
BAL Concentration of IL8 (pg/mL)
Pre-Bypass
|
2008.50 pg/mL
Interval 341.25 to 16444.75
|
6528.50 pg/mL
Interval 625.0 to 16332.25
|
|
BAL Concentration of IL8 (pg/mL)
Post-Bypass
|
8019.50 pg/mL
Interval 998.25 to 100438.0
|
27789.50 pg/mL
Interval 4780.5 to 154087.75
|
|
BAL Concentration of IL8 (pg/mL)
Difference
|
4701.00 pg/mL
Interval -290.25 to 77061.0
|
16230.00 pg/mL
Interval 1399.25 to 123098.5
|
SECONDARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassInflammatory mediator found in BAL fluid during lung inflammation
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
BAL Concentration of MCP1 (pg/mL)
Pre-Bypass
|
509.50 pg/mL
Interval 249.25 to 1415.75
|
977.50 pg/mL
Interval 336.5 to 1225.75
|
|
BAL Concentration of MCP1 (pg/mL)
Post-Bypass
|
496.00 pg/mL
Interval 184.25 to 2153.25
|
883.50 pg/mL
Interval 651.5 to 4380.5
|
|
BAL Concentration of MCP1 (pg/mL)
Difference
|
148.00 pg/mL
Interval -265.75 to 869.75
|
479.50 pg/mL
Interval -104.25 to 1482.75
|
SECONDARY outcome
Timeframe: Change from baseline and 2-4 hours after exposure to cardiopulmonary bypassBiomarker of lung injury (RAGE - receptor for advance glycosylation end products)
Outcome measures
| Measure |
Inhaled Anesthesia
n=18 Participants
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 Participants
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
BAL Concentration of sRAGE (pg/mL)
Pre-Bypass
|
156.50 pg/mL
Interval 44.0 to 383.0
|
164 pg/mL
Interval 60.75 to 380.5
|
|
BAL Concentration of sRAGE (pg/mL)
Post-Bypass
|
597.00 pg/mL
Interval 220.5 to 1195.0
|
465.00 pg/mL
Interval 206.0 to 2120.5
|
|
BAL Concentration of sRAGE (pg/mL)
Difference
|
402.50 pg/mL
Interval 155.25 to 1063.25
|
224.50 pg/mL
Interval -69.25 to 2088.25
|
Adverse Events
Inhaled Anesthesia
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Intravenous Anesthesia
Serious events: 0 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inhaled Anesthesia
n=18 participants at risk
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane: Volatile Anesthetic
|
Intravenous Anesthesia
n=22 participants at risk
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol: Intravenous Anesthetic
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Prolonged intubation (greater than 48hrs)
|
0.00%
0/18 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
13.6%
3/22 • Number of events 3 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Failed extubation (re-intubated within 24hrs)
|
0.00%
0/18 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
4.5%
1/22 • Number of events 1 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Reintubation (greater than 24hrs after extubation)
|
0.00%
0/18 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
9.1%
2/22 • Number of events 2 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
22.2%
4/18 • Number of events 4 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
36.4%
8/22 • Number of events 8 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
94.4%
17/18 • Number of events 17 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
95.5%
21/22 • Number of events 21 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
88.9%
16/18 • Number of events 16 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
86.4%
19/22 • Number of events 19 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Infiltrate/consolidation
|
33.3%
6/18 • Number of events 6 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
27.3%
6/22 • Number of events 6 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Number of events 1 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
22.7%
5/22 • Number of events 5 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/18 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
4.5%
1/22 • Number of events 1 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Brochospasm
|
5.6%
1/18 • Number of events 1 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
4.5%
1/22 • Number of events 1 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (PaO2/FiO2 < 300)
|
88.9%
16/18 • Number of events 16 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
68.2%
15/22 • Number of events 15 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis (PaCO2 > 45)
|
66.7%
12/18 • Number of events 12 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
68.2%
15/22 • Number of events 15 • During hospital length of stay ~7 days
During this study, the research team did not record every adverse event. As shown in the table below (as well as the Outcome Measure 2 data), only study related events were recorded.
|
Additional Information
Dr. Brian P. O'Gara
Beth Israel Deaconess Medical Center
Phone: 617-549-2974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place