Trial Outcomes & Findings for Thrombolysis in Pediatric Stroke (TIPS) (NCT NCT01591096)
NCT ID: NCT01591096
Last Updated: 2018-05-25
Results Overview
Any PH 2 OR, Any intracranial hemorrhage which is judged to be the most important cause of neurological deterioration (a minimum of change of 2 or more points on the PedNIHSS from the lowest PedNIHSS). At the time of each PedNIHSS assessment, the site PI or co-PI will review the patient's course with the care team to ensure that all changes in neurologic status, including improvements since the last assessment by the study team, are captured, OR, Any hemorrhage that results in the need for transfusion, need to discontinue study drug, surgical evacuation of hemorrhage, or death.
TERMINATED
PHASE1
1 participants
36 hours
2018-05-25
Participant Flow
1 patient was recruited for the study, however, they did not receive the intervention due to an AE
Participant milestones
| Measure |
Tissue Plasminogen Activator
All patients will receive study drug.
Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Tissue Plasminogen Activator
All patients will receive study drug.
Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.
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|---|---|
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Overall Study
Adverse Event
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1
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Baseline Characteristics
Thrombolysis in Pediatric Stroke (TIPS)
Baseline characteristics by cohort
| Measure |
Tissue Plasminogen Activator
n=1 Participants
All patients will receive study drug.
Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.
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|---|---|
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Age, Categorical
<=18 years
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1 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Sex: Female, Male
Female
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1 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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1 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 36 hoursPopulation: Data cannot be reported in the data table as no data was collected
Any PH 2 OR, Any intracranial hemorrhage which is judged to be the most important cause of neurological deterioration (a minimum of change of 2 or more points on the PedNIHSS from the lowest PedNIHSS). At the time of each PedNIHSS assessment, the site PI or co-PI will review the patient's course with the care team to ensure that all changes in neurologic status, including improvements since the last assessment by the study team, are captured, OR, Any hemorrhage that results in the need for transfusion, need to discontinue study drug, surgical evacuation of hemorrhage, or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data cannot be reported in the data table as no data was collected
TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursPopulation: Data cannot be reported in the data table as no data was collected
TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.
Outcome measures
Outcome data not reported
Adverse Events
Tissue Plasminogen Activator
Serious adverse events
| Measure |
Tissue Plasminogen Activator
n=1 participants at risk
All patients will receive study drug.
Tissue plasminogen activator (Activase®): Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.
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|---|---|
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Cardiac disorders
Hypoventilation, bradycardia
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100.0%
1/1 • Number of events 1
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place