Trial Outcomes & Findings for Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery (NCT NCT02498769)

Last Updated: 2019-02-22

Results Overview

Patients will be seen on a daily basis and the timing of POAF compared between groups. The occurrence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks) and the time from surgery to the first and subsequent episodes of POAF recorded and compared between groups. POAF will be determined by ECG or telemetry.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

130 participants

Primary outcome timeframe

From the time of ICU arrival until the time of first documented POAF, or discharge whichever came first, assessed up to 2 weeks

Results posted on

2019-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Epicardial Botulinum After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Overall Study STARTED	63	67
Overall Study COMPLETED	63	67
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epicardial Botulinum n=63 Participants After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 Participants After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo	Total n=130 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 8.6 • n=99 Participants	67.5 years STANDARD_DEVIATION 9.1 • n=107 Participants	67.0 years STANDARD_DEVIATION 8.9 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	23 Participants n=107 Participants	40 Participants n=206 Participants
Sex: Female, Male Male	46 Participants n=99 Participants	44 Participants n=107 Participants	90 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=99 Participants	67 Participants n=107 Participants	128 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants	9 Participants n=107 Participants	15 Participants n=206 Participants
Race (NIH/OMB) White	55 Participants n=99 Participants	57 Participants n=107 Participants	112 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	63 participants n=99 Participants	67 participants n=107 Participants	130 participants n=206 Participants

PRIMARY outcome

Timeframe: From the time of ICU arrival until the time of first documented POAF, or discharge whichever came first, assessed up to 2 weeks

Outcome measures

Outcome measures
Measure	Epicardial Botulinum n=63 Participants After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 Participants After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Time to In-hospital Post-operative Atrial Fibrillation (POAF)	224.38 hours Standard Error 19.31	194.76 hours Standard Error 18.36

SECONDARY outcome

Timeframe: The incidence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks)

Patients will be seen on a daily basis and the occurrence of POAF compared between groups.

Outcome measures

Outcome measures
Measure	Epicardial Botulinum n=63 Participants After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 Participants After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Number of Participants With In-hospital POAF	23 Participants	32 Participants

SECONDARY outcome

Timeframe: ICU length of stay was measured from time of surgery to time of ICU discharge. Post-operative length of stay was measured from time of surgery to time of hospital discharge.

Total and ICU length of stay will be determined by examining medical records for the length of inpatient hospitalization, assessed over the entire study period (up to two years). ICU and hospital LOS will be recorded and compared between groups

Outcome measures

Outcome measures
Measure	Epicardial Botulinum n=63 Participants After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 Participants After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Length of Stay ICU LOS in hours	25.7 time in hours Interval 22.4 to 40.2	23.1 time in hours Interval 20.0 to 34.0
Length of Stay Post-operative LOS in hours	145 time in hours Interval 121.0 to 201.0	149 time in hours Interval 125.0 to 213.0

SECONDARY outcome

Timeframe: Adverse events from the time of surgery through hospital discharge, up to 2 weeks

The total number of postoperative complications (including infectious, neurologic, and renal complications, as well as mortality) and the number of subjects with complications will be monitored and compared between groups.

Outcome measures

Outcome measures
Measure	Epicardial Botulinum n=63 Participants After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 Participants After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Number of Participants With Adverse Events	44 Participants	47 Participants

Adverse Events

Epicardial Botulinum

Serious events: 27 serious events

Other events: 10 other events

Deaths: 1 deaths

Epicardial Placebo

Serious events: 30 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Epicardial Botulinum n=63 participants at risk After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 participants at risk After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Cardiac disorders Atrial Dysrhythmia - Atrial Fibrillation	7.9% 5/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	16.4% 11/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Blood and lymphatic system disorders Thrombocytopenia	7.9% 5/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	4.5% 3/67 • Adverse events from the time of randomization through hospital discharge following study surgery.

Additional Information

Dr. Joseph P Mathew Professor of Anesthesiology and Chairman Department of Anesthesiology

Duke University Health System

Phone: 919-681-6646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Epicardial Botulinum n=63 participants at risk After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Botulinum Toxin Type A: The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.	Epicardial Placebo n=67 participants at risk After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge. Placebo
Cardiac disorders Atrial Dysrhythmia - Atrial Fibrillation	28.6% 18/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	31.3% 21/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Renal and urinary disorders Acute Kidney Injury	3.2% 2/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	6.0% 4/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Blood and lymphatic system disorders Leukocytosis	4.8% 3/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	4.5% 3/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	7.5% 5/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Renal and urinary disorders Urinary Tract Infection	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	4.5% 3/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders Heart Block	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	3.0% 2/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders Hypotension	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	3.0% 2/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Gastrointestinal disorders Ileus	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	3.0% 2/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Surgical and medical procedures Reexploration For Bleeding	3.2% 2/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.2% 2/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Left pneumothorax	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Nervous system disorders Oropharyngeal dysphagia	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	3.2% 2/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Infections and infestations Sternal Wound Infection	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Gastrointestinal disorders Acute abdomen dilation	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure/hypoxia	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Nervous system disorders Altered Mental Status	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Vascular disorders Bilateral Toe and Index finger ischemia.	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Gastrointestinal disorders Colitis	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Renal and urinary disorders Dialysis	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Metabolism and nutrition disorders Hyperglycemia	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders Hypovolemia	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders IABP placement	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Gastrointestinal disorders Nausea/Vomiting/Constipation	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders Pacemaker Placement	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Reintubation	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Renal and urinary disorders Renal Insufficiency	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Nervous system disorders Right sided weakness	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Nervous system disorders Stroke	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Renal and urinary disorders Urinary Incontinence leading to foley re-insertion	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders Ventricular Dysrhythmia - Ventricular Tachycardia	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Cardiac disorders junctional rhythm	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Surgical and medical procedures post-op hemorrhage, back to OR for re-exploration	1.6% 1/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	0.00% 0/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Blood and lymphatic system disorders Post-op blood loss anemia requiring transfusions	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	4.5% 3/67 • Adverse events from the time of randomization through hospital discharge following study surgery.
Blood and lymphatic system disorders prolonged hospitalization c/o coagulation.	0.00% 0/63 • Adverse events from the time of randomization through hospital discharge following study surgery.	1.5% 1/67 • Adverse events from the time of randomization through hospital discharge following study surgery.