Trial Outcomes & Findings for Preconditioning for Aneurismal Subarachnoid Hemorrhage (NCT NCT01110239)
NCT ID: NCT01110239
Last Updated: 2017-06-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
90 days
Results posted on
2017-06-09
Participant Flow
Subjects admitted to a large community based teaching hospital were recruited between November 2008 and July 2010.
Participant milestones
| Measure |
Sham Preconditioning
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
|
5-min Ischemia
|
7.5-min Ischemia
|
10-min Ischemia
|
|---|---|---|---|---|
|
Sham Preconditioning
STARTED
|
7
|
14
|
7
|
6
|
|
Sham Preconditioning
COMPLETED
|
7
|
14
|
6
|
6
|
|
Sham Preconditioning
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
5 Min Ischemia
STARTED
|
0
|
14
|
0
|
0
|
|
5 Min Ischemia
COMPLETED
|
0
|
0
|
0
|
0
|
|
5 Min Ischemia
NOT COMPLETED
|
0
|
14
|
0
|
0
|
|
7.5 Min Ischemia
STARTED
|
0
|
0
|
7
|
0
|
|
7.5 Min Ischemia
COMPLETED
|
0
|
0
|
6
|
0
|
|
7.5 Min Ischemia
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
10 Min Ischemia
STARTED
|
0
|
0
|
0
|
6
|
|
10 Min Ischemia
COMPLETED
|
0
|
0
|
0
|
6
|
|
10 Min Ischemia
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sham Preconditioning
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
|
5-min Ischemia
|
7.5-min Ischemia
|
10-min Ischemia
|
|---|---|---|---|---|
|
Sham Preconditioning
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
7.5 Min Ischemia
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Preconditioning for Aneurismal Subarachnoid Hemorrhage
Baseline characteristics by cohort
| Measure |
Sham Preconditioning
n=7 Participants
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
|
5 Min Ischemia
n=14 Participants
|
7.5 Min Ischemia
n=7 Participants
|
10 Min Ischemia
n=6 Participants
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 9 • n=5 Participants
|
53 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10 • n=4 Participants
|
52 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Sham Preconditioning
n=7 Participants
leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
|
5 Min Ischemia
n=14 Participants
|
7.5 Min Ischemia
n=6 Participants
|
10 Min Ischemia
n=6 Participants
|
|---|---|---|---|---|
|
Number of Patients With Deep Vein Thrombosis for Safety Assessment.
|
0 participants
|
3 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: We escalated the ischemia times in cohorts of 6. Cohorts of 6 were prespecified at the beginning to the study. All analysis was intention to treat
The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.
Outcome measures
| Measure |
Sham Preconditioning
n=7 Participants
leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
|
5 Min Ischemia
n=14 Participants
|
7.5 Min Ischemia
n=6 Participants
|
10 Min Ischemia
n=6 Participants
|
|---|---|---|---|---|
|
Visual Analog Scale Score as a Measure of Tolerability
|
0 units on a scale
Standard Deviation 0
|
3.6 units on a scale
Standard Deviation 3.4
|
1.8 units on a scale
Standard Deviation 2.1
|
2.5 units on a scale
Standard Deviation 2.9
|
Adverse Events
Sham Preconditioning
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
5 Min Ischemia
Serious events: 9 serious events
Other events: 8 other events
Deaths: 0 deaths
7.5 Min Ischemia
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
10 Min Ischemia
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Preconditioning
n=7 participants at risk
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
|
5 Min Ischemia
n=14 participants at risk
|
7.5 Min Ischemia
n=7 participants at risk
|
10 Min Ischemia
n=6 participants at risk
|
|---|---|---|---|---|
|
Nervous system disorders
Delayed cerebral ischemia
|
28.6%
2/7
|
28.6%
4/14
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Blood and lymphatic system disorders
low hematocrit
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/6
|
|
General disorders
death
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
ventriculitis
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
16.7%
1/6
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/7
|
21.4%
3/14
|
0.00%
0/7
|
0.00%
0/6
|
Other adverse events
| Measure |
Sham Preconditioning
n=7 participants at risk
Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
|
5 Min Ischemia
n=14 participants at risk
|
7.5 Min Ischemia
n=7 participants at risk
|
10 Min Ischemia
n=6 participants at risk
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
hyponatremia
|
57.1%
4/7
|
21.4%
3/14
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
pneumonia
|
0.00%
0/7
|
21.4%
3/14
|
14.3%
1/7
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
low hematocrit
|
0.00%
0/7
|
7.1%
1/14
|
0.00%
0/7
|
16.7%
1/6
|
|
Infections and infestations
urinary tract infection
|
14.3%
1/7
|
21.4%
3/14
|
14.3%
1/7
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
0.00%
0/7
|
0.00%
0/14
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
stridor
|
0.00%
0/7
|
0.00%
0/14
|
0.00%
0/7
|
16.7%
1/6
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
14.3%
1/7
|
0.00%
0/14
|
0.00%
0/7
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place