Trial Outcomes & Findings for Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization (NCT NCT01778855)
NCT ID: NCT01778855
Last Updated: 2017-04-13
Results Overview
To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition. Additional data for secondary analyses were not acquired to permit analyses.
TERMINATED
PHASE2/PHASE3
6 participants
36 hours
2017-04-13
Participant Flow
Participant milestones
| Measure |
Normothermia
IV t-PA and normothermia
|
Hypothermia
IV t-PA and hypothermia
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normothermia
IV t-PA and normothermia
|
Hypothermia
IV t-PA and hypothermia
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization
Baseline characteristics by cohort
| Measure |
Normothermia
n=2 Participants
IV t-PA and normothermia
|
Hypothermia
n=4 Participants
IV t-PA and hypothermia
|
Total
n=6 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 hoursPopulation: Recanalization at 36 hours
To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition. Additional data for secondary analyses were not acquired to permit analyses.
Outcome measures
| Measure |
Normothermia
n=2 Participants
IV t-PA and normothermia
|
Hypothermia
n=4 Participants
IV t-PA and hypothermia
|
|---|---|---|
|
Number of Participants With Recanalization
|
2 Participants
|
3 Participants
|
Adverse Events
Normothermia
Hypothermia
Serious adverse events
| Measure |
Normothermia
n=2 participants at risk
IV t-PA and normothermia
|
Hypothermia
n=4 participants at risk
IV t-PA and hypothermia
|
|---|---|---|
|
Cardiac disorders
Congestive Heart Failure
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Death
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Normothermia
n=2 participants at risk
IV t-PA and normothermia
|
Hypothermia
n=4 participants at risk
IV t-PA and hypothermia
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal coagulation profile
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Cerebral edema
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Cardiac disorders
Elevated troponin
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Fever
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Fluid overload
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Pain
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Topical fungal infection
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Hepatobiliary disorders
Transaminitis
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place