Trial Outcomes & Findings for PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding (NCT NCT02557672)
NCT ID: NCT02557672
Last Updated: 2022-06-07
Results Overview
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
106 participants
Primary outcome timeframe
24 hours
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Fresh Frozen Plasma
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (PCC) (Human): PCC (Kcentra)
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Fresh Frozen Plasma
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (PCC) (Human): PCC (Kcentra)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
Baseline characteristics by cohort
| Measure |
Fresh Frozen Plasma
n=49 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 14.6 • n=39 Participants
|
68.1 years
STANDARD_DEVIATION 12.8 • n=41 Participants
|
66.8 years
STANDARD_DEVIATION 13.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
61 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
48 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
98 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=39 Participants
|
51 participants
n=41 Participants
|
100 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 1 subject's data was not collected nor analyzed for the FFP arm
The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL.
Outcome measures
| Measure |
Fresh Frozen Plasma
n=48 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Chest Tube Output
|
1022 mL
Interval 799.0 to 1575.0
|
937 mL
Interval 708.0 to 1443.0
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 1 subject data was not collected nor analyzed for the FFP arm
The number of subject's who received 0,1,2,3 or more units of RBC's transfused from completion of study drug administration though midnight of the next day.
Outcome measures
| Measure |
Fresh Frozen Plasma
n=48 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Red Blood Cell (RBC) Blood Product Transfusion
0 units
|
26 Participants
|
36 Participants
|
|
Red Blood Cell (RBC) Blood Product Transfusion
1 unit
|
11 Participants
|
8 Participants
|
|
Red Blood Cell (RBC) Blood Product Transfusion
2 units
|
6 Participants
|
5 Participants
|
|
Red Blood Cell (RBC) Blood Product Transfusion
3 or more units
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 1 subject's data was not collected nor analyzed for the FFP arm
The number of subject's who received 0,1,2,3 or more units of Platelets transfused from completion of study drug administration though midnight of the next day.
Outcome measures
| Measure |
Fresh Frozen Plasma
n=48 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Platelets Blood Product Transfusion
0 units
|
30 Participants
|
36 Participants
|
|
Platelets Blood Product Transfusion
1 unit
|
13 Participants
|
9 Participants
|
|
Platelets Blood Product Transfusion
2 units
|
3 Participants
|
3 Participants
|
|
Platelets Blood Product Transfusion
3 or more units
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 1 subject's data was not collected nor analyzed for the FFP arm
The number of subject's who received 0,1,2,3 or more units of Cryo's transfused from completion of study drug administration though midnight of the next day.
Outcome measures
| Measure |
Fresh Frozen Plasma
n=48 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Cryoprecipitate (Cryo) Blood Product Transfusion
0 units
|
40 Participants
|
40 Participants
|
|
Cryoprecipitate (Cryo) Blood Product Transfusion
1 unit
|
2 Participants
|
2 Participants
|
|
Cryoprecipitate (Cryo) Blood Product Transfusion
2 units
|
5 Participants
|
8 Participants
|
|
Cryoprecipitate (Cryo) Blood Product Transfusion
3 or more units
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 1 subject's data was not collected nor analyzed for the FFP arm
The number of subject's who received 0,1,2,3 or more units of FFP's transfused from completion of study drug administration though midnight of the next day.
Outcome measures
| Measure |
Fresh Frozen Plasma
n=48 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 Participants
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Fresh Frozen Plasma (FFP) Blood Product Transfusion
0 units
|
43 Participants
|
48 Participants
|
|
Fresh Frozen Plasma (FFP) Blood Product Transfusion
1 unit
|
0 Participants
|
1 Participants
|
|
Fresh Frozen Plasma (FFP) Blood Product Transfusion
2 units
|
4 Participants
|
2 Participants
|
|
Fresh Frozen Plasma (FFP) Blood Product Transfusion
3 or more units
|
1 Participants
|
0 Participants
|
Adverse Events
Fresh Frozen Plasma
Serious events: 44 serious events
Other events: 0 other events
Deaths: 2 deaths
Prothrombin Complex Concentrate
Serious events: 45 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Fresh Frozen Plasma
n=49 participants at risk
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.
Fresh frozen plasma (FFP): FFP
|
Prothrombin Complex Concentrate
n=51 participants at risk
After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.
Prothrombin complex concentrate (Human): PCC (Kcentra)
|
|---|---|---|
|
Immune system disorders
Anaphylactic or allergic reaction
|
2.0%
1/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
0.00%
0/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Vascular disorders
Thromboembolic event
|
4.1%
2/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
2.0%
1/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Vascular disorders
DVT
|
0.00%
0/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
2.0%
1/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Vascular disorders
Mesenteric ischemia
|
6.1%
3/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
2.0%
1/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Nervous system disorders
Stroke/TIA
|
2.0%
1/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
3.9%
2/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Cardiac disorders
STEMI
|
2.0%
1/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
0.00%
0/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Renal and urinary disorders
Renal Failure
|
36.7%
18/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
41.2%
21/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Renal and urinary disorders
Renal Failure requiring dialysis
|
8.2%
4/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
9.8%
5/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
8.2%
4/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
7.8%
4/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged mechanical ventilation
|
10.2%
5/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
13.7%
7/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
|
General disorders
Re-operation
|
10.2%
5/49 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
5.9%
3/51 • Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place