Trial Outcomes & Findings for Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study (NCT NCT00373269)
NCT ID: NCT00373269
Last Updated: 2017-02-27
Results Overview
FVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
Recruitment status
COMPLETED
Target enrollment
21 participants
Primary outcome timeframe
Baseline
Results posted on
2017-02-27
Participant Flow
Participant milestones
| Measure |
Normoglycemic Control
Subjects with acute ischemic stroke and normal blood glucose.
|
Hyperglycemic Subjects
Subjects with acute ischemic stroke and hyperglycemia.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Procoagulant Effects of Hyperglycemia After Acute Stroke: A Pilot Study
Baseline characteristics by cohort
| Measure |
Normoglycemic
n=11 Participants
Subjects with acute ischemic stroke and normal blood glucose.
|
Hyperglycemic
n=10 Participants
Subjects with acute ischemic stroke and hyperglycemia.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 17.7 • n=99 Participants
|
63.5 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
64.2 years
STANDARD_DEVIATION 18.4 • n=206 Participants
|
|
Gender
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Gender
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineFVIIa levels were compared between the normoglycemic and hyperglycemic subjects.
Outcome measures
| Measure |
Normoglycemic Control
n=11 Participants
Subjects with acute ischemic stroke and normal blood glucose.
|
Hyperglycemic Subjects
n=10 Participants
Subjects with acute ischemic stroke and hyperglycemia.
|
|---|---|---|
|
FVIIa
|
69.7 mU/ml
Standard Deviation 33.3
|
124.4 mU/ml
Standard Deviation 35.2
|
SECONDARY outcome
Timeframe: BaselineTF-PCA levels compared between normoglycemic and hyperglycemic subjects.
Outcome measures
| Measure |
Normoglycemic Control
n=11 Participants
Subjects with acute ischemic stroke and normal blood glucose.
|
Hyperglycemic Subjects
n=10 Participants
Subjects with acute ischemic stroke and hyperglycemia.
|
|---|---|---|
|
TF-PCA
|
183.5 U/ml
Standard Deviation 63.1
|
118.1 U/ml
Standard Deviation 56.9
|
Adverse Events
Diabetic Subject
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normoglycemic Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place