Trial Outcomes & Findings for S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT (NCT NCT01312675)
NCT ID: NCT01312675
Last Updated: 2018-10-12
Results Overview
The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8. The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function). Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline through Day 8
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
Group A
S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
|
Group B
Standard of Care therapy alone
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
Baseline characteristics by cohort
| Measure |
Group A
n=9 Participants
S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
|
Group B
n=7 Participants
Standard of Care therapy alone
|
Total
n=16 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 8Population: Intent to Treat (ITT)
The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8. The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function). Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition.
Outcome measures
| Measure |
Group A
n=9 Participants
S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
|
Group B
n=7 Participants
Standard of Care therapy alone
|
|---|---|---|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Screening
|
7.4 scores on a scale
Standard Deviation 2.70
|
11.9 scores on a scale
Standard Deviation 3.24
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 2
|
6.9 scores on a scale
Standard Deviation 2.09
|
11.4 scores on a scale
Standard Deviation 3.10
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 1 / Baseline
|
6.9 scores on a scale
Standard Deviation 2.57
|
11.9 scores on a scale
Standard Deviation 2.41
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 3
|
6.1 scores on a scale
Standard Deviation 2.10
|
10.4 scores on a scale
Standard Deviation 3.41
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 4
|
6.6 scores on a scale
Standard Deviation 2.83
|
9.0 scores on a scale
Standard Deviation 3.61
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 5
|
6.9 scores on a scale
Standard Deviation 2.97
|
7.0 scores on a scale
Standard Deviation 4.08
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 6
|
5.6 scores on a scale
Standard Deviation 3.55
|
7.1 scores on a scale
Standard Deviation 2.85
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 7
|
5.1 scores on a scale
Standard Deviation 3.93
|
8.1 scores on a scale
Standard Deviation 2.91
|
|
Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)
Day 8
|
4.3 scores on a scale
Standard Deviation 2.81
|
7.7 scores on a scale
Standard Deviation 1.98
|
Adverse Events
Group A
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Group B
Serious events: 5 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group A
n=9 participants at risk
S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
|
Group B
n=7 participants at risk
Standard of Care therapy alone
|
|---|---|---|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 4 • 28 days per subject.
|
|
Infections and infestations
Gangrene
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Infections and infestations
Septic Shock
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
Other adverse events
| Measure |
Group A
n=9 participants at risk
S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
|
Group B
n=7 participants at risk
Standard of Care therapy alone
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 3 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
22.2%
2/9 • Number of events 5 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
22.2%
2/9 • Number of events 3 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Cardiac disorders
Tachycardia
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Endocrine disorders
Adrenal insufficiency
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Abdonimal pain
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Gastrointestinal disorders
Upper gi haemorrhage
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
General disorders
Asthenia
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
General disorders
Impaired Healing
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
General disorders
Local Swelling
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 6 • 28 days per subject.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Infections and infestations
Brucellosis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Infections and infestations
Candida infection
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Infections and infestations
Pneumonia
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Injury, poisoning and procedural complications
Excoriation
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Blood alkaline phosphate increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Blood urea increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Acidosis
|
11.1%
1/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 2 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • 28 days per subject.
|
42.9%
3/7 • Number of events 9 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
11.1%
1/9 • Number of events 2 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
22.2%
2/9 • Number of events 8 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
1/9 • Number of events 5 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.2%
2/9 • Number of events 8 • 28 days per subject.
|
14.3%
1/7 • Number of events 4 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 2 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
3/9 • Number of events 7 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
22.2%
2/9 • Number of events 6 • 28 days per subject.
|
14.3%
1/7 • Number of events 2 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Metabolism and nutrition disorders
Malnutrition
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Nervous system disorders
Hepatic encephalopathy
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Nervous system disorders
Neuralgia
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Psychiatric disorders
Agitation
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Psychiatric disorders
Delirium
|
22.2%
2/9 • Number of events 2 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 3 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/9 • 28 days per subject.
|
28.6%
2/7 • Number of events 2 • 28 days per subject.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 2 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Surgical and medical procedures
Skin operation
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
0.00%
0/7 • 28 days per subject.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Jugular vein thrombosis
|
11.1%
1/9 • Number of events 1 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/9 • 28 days per subject.
|
14.3%
1/7 • Number of events 1 • 28 days per subject.
|
Additional Information
Dr. Diana Velencia, Associate Director of Clinical Affairs
B. Braun Medical Inc.
Phone: 610-596-2875
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study sites are able to publish on their own data if Sponsor does not publish a multi-center study paper within 18 months after trial completion. Sites agree to submit any proposed publication, presentation or other public disclosure to Sponsor for review at least 30 days prior to submitting to a publisher or other 3rd party. Within 30 days of receipt, Sponsor shall advise removal of any confidential information or which may impair Sponsor's ability to obtain patent protection.
- Publication restrictions are in place
Restriction type: OTHER