Trial Outcomes & Findings for To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients (NCT NCT02064959)
NCT ID: NCT02064959
Last Updated: 2020-10-19
Results Overview
Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
6 months post injury
Results posted on
2020-10-19
Participant Flow
Subjects were randomized and enrolled prior to evacuation of Subdural hematoma
Participant milestones
| Measure |
Normothermia
Control, temperature maintained at 37°C
|
Hypothermia
treatment group, temperature at 35°C at dura opening then 33°C \> 48 hours
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two regions enrolled subjects in this study
Baseline characteristics by cohort
| Measure |
Normothermia
n=16 Participants
Control, temperature maintained at 37 degrees C
|
Hypothermia
n=16 Participants
treatment group, temperature at 35 degrees C at dura opening then 33 degrees C \> 48 hours
|
Total
n=32 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
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Participants · Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Participants · Male
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 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
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants • Two regions enrolled subjects in this study
|
13 participants
n=7 Participants • Two regions enrolled subjects in this study
|
25 participants
n=5 Participants • Two regions enrolled subjects in this study
|
|
Region of Enrollment
Japan
|
4 participants
n=5 Participants • Two regions enrolled subjects in this study
|
3 participants
n=7 Participants • Two regions enrolled subjects in this study
|
7 participants
n=5 Participants • Two regions enrolled subjects in this study
|
|
Subdural hematoma present
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post injuryParticipants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
Outcome measures
| Measure |
Normothermia
n=16 Participants
Control, temperature maintained at 37 degrees °C
|
Hypothermia
n=16 Participants
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C \> 48 hours
|
|---|---|---|
|
Number of Participants With Favorable Glasgow Outcome Score-Extended (GOS-E) at 6 Months Post Injury
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 months post injuryAdverse events were graded according to the USDHHS Common Terminology Criteria for Adverse Events V4.0. Serious adverse events and pre-defined adverse events of interest that historically were known to be of concern with hypothermia treatment were selected to be monitored and reported regardless of grade. These included cardiac arrhythmias, thromboembolic events, pneumonia, bleeding or hemorrhage, intraoperative hemorrhage, infection (culture positive, e.g., blood stream infection, urinary tract infection, ventriculitis), device-related infection, and death. The number of adverse events per participant were compared between groups.
Outcome measures
| Measure |
Normothermia
n=16 Participants
Control, temperature maintained at 37 degrees °C
|
Hypothermia
n=16 Participants
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C \> 48 hours
|
|---|---|---|
|
Safety as Assessed by Number of Adverse Events Reported Per Participant
|
4.500 number of adverse events per participant
Interval 0.25 to 9.0
|
4.000 number of adverse events per participant
Interval 2.0 to 7.75
|
SECONDARY outcome
Timeframe: from ICU admission to ICU discharge (median of about 11 to 13 days)Population: Data was not collected for one participant in the normothermia arm.
Outcome measures
| Measure |
Normothermia
n=15 Participants
Control, temperature maintained at 37 degrees °C
|
Hypothermia
n=16 Participants
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C \> 48 hours
|
|---|---|---|
|
Intensive Care Unit (ICU) Length of Stay
|
11.390 days
Interval 7.948 to 32.429
|
12.946 days
Interval 9.234 to 17.719
|
SECONDARY outcome
Timeframe: from hospital admission to hospital discharge (median of about 18 to 21 days)Population: Data was not collected for one participant in the normothermia arm.
Outcome measures
| Measure |
Normothermia
n=15 Participants
Control, temperature maintained at 37 degrees °C
|
Hypothermia
n=16 Participants
treatment group, temperature at 35 degrees °C at dura opening then 33 degrees °C \> 48 hours
|
|---|---|---|
|
Hospital Length of Stay
|
18.243 days
Interval 8.165 to 45.84
|
20.674 days
Interval 17.769 to 29.784
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Normothermia
Serious events: 10 serious events
Other events: 10 other events
Deaths: 5 deaths
Hypothermia
Serious events: 11 serious events
Other events: 12 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Normothermia
n=16 participants at risk
Control, temperature maintained at 37°C
|
Hypothermia
n=16 participants at risk
treatment group, temperature at 35°C at dura opening then 33°C \> 48 hours
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
6/16 • Number of events 10 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
25.0%
4/16 • Number of events 10 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Blood and lymphatic system disorders
Elevated white blood cell count
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Cardiac disorders
Sinus Bradycardia
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Cardiac disorders
Tachycardia,agitation
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Gastrointestinal disorders
Infection
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Gastrointestinal disorders
Mesenteric ischemia with lactic acid disorder (elevated)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Hepatobiliary disorders
Cholecystitis, acute
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
hyperglycemia
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 5 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
25.0%
4/16 • Number of events 5 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
4/16 • Number of events 5 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 5 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
4/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Death
|
31.2%
5/16 • Number of events 8 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
18.8%
3/16 • Number of events 8 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Epidural hematoma
|
12.5%
2/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
hospital readmission,facial droop
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Hydrocephalus
|
12.5%
2/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Elevated intracranial pressure
|
12.5%
2/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Intracranial Hemorrhage
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Muscle weakness upper limb
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Neurological worsening
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Stroke
|
31.2%
5/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Swelling and Hemorrhage during surgery
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Worsening contusion
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Renal and urinary disorders
Urinary Tract infection
|
12.5%
2/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Hospital readmission/chest wall hematoma
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
25.0%
4/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
31.2%
5/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Sepsis
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Surgical and medical procedures
Vascular Access Complication
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Vascular disorders
hypotension
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Vascular disorders
Thromboembolic event
|
31.2%
5/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
25.0%
4/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
Other adverse events
| Measure |
Normothermia
n=16 participants at risk
Control, temperature maintained at 37°C
|
Hypothermia
n=16 participants at risk
treatment group, temperature at 35°C at dura opening then 33°C \> 48 hours
|
|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
4/16 • Number of events 8 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
25.0%
4/16 • Number of events 8 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Blood and lymphatic system disorders
CPK Increased
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Blood and lymphatic system disorders
Lymphocyte decreased
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Cardiac disorders
Sinus Bradycardia
|
6.2%
1/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
General disorders
Fever
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Hepatobiliary disorders
Blood Bilirubin increased
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Hepatobiliary disorders
Liver dysfunction
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Investigations
lipase increased
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Alkalosis
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 2 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
2/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 3 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
2/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
25.0%
4/16 • Number of events 6 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Musculoskeletal and connective tissue disorders
Wound Infection
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Cranioplasty
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Hydrocephalus
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
seizure
|
12.5%
2/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
12.5%
2/16 • Number of events 4 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Brain abscess
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Meningitis
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Nervous system disorders
Neurological worsening
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
18.8%
3/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
37.5%
6/16 • Number of events 9 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Skin and subcutaneous tissue disorders
scalp wound/infection
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Skin and subcutaneous tissue disorders
Wound drainage
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Surgical and medical procedures
Replacement of catheter
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
|
Vascular disorders
Thrombus(superficial)
|
6.2%
1/16 • Number of events 1 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
0.00%
0/16 • 6 months post injury
Adverse events with a grade of 3 or higher or predefined adverse events of interest(cardiac arrhythmia, thromboembolic event, pneumonia, pulmonary edema,bleeding/hemorrhage,infection(culture positive), device -related infection, Death)
|
Additional Information
Georgene W. Hergenroeder, Ph.D., Associate Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-6230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place