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Trial record 42 of 611 for:    PLG

Thrombolysis in Pediatric Stroke (TIPS) (TIPS)

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ClinicalTrials.gov Identifier: NCT01591096
Recruitment Status : Terminated (Lack of patient accrual)
First Posted : May 3, 2012
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
The Hospital for Sick Children
Medical College of Wisconsin
University of Texas at Austin
Alberta Children's Hospital
McMaster University
Information provided by (Responsible Party):
Catherine Amlie-Lefond, Seattle Children's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Intervention Drug: Tissue plasminogen activator (Activase®)
Enrollment 1
Recruitment Details  
Pre-assignment Details 1 patient was recruited for the study, however, they did not receive the intervention due to an AE
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
1
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Symptomatic Intracranial Hemorrhage
Hide Description 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.
Time Frame 36 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data cannot be reported in the data table as no data was collected
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pharmacokinetics of tPA
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data cannot be reported in the data table as no data was collected
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pharmacokinetics of tPA
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data cannot be reported in the data table as no data was collected
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tissue Plasminogen Activator
Hide Arm/Group Description

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.

All-Cause Mortality
Tissue Plasminogen Activator
Affected / at Risk (%)
Total   0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Tissue Plasminogen Activator
Affected / at Risk (%) # Events
Total   1    
Cardiac disorders   
Hypoventilation, bradycardia  [1]  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
[1]
Patient developed hypoventilation and bradycardia after extubation following sedation for head MRI and MRA. (no tPA given).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tissue Plasminogen Activator
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Early termination due to lack of participant accrual.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Catherine Amlie-Lefond MD
Organization: SeattleChildrens
Phone: 206-987-2078
Responsible Party: Catherine Amlie-Lefond, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01591096     History of Changes
Other Study ID Numbers: 1R01NS065818 ( U.S. NIH Grant/Contract )
First Submitted: May 1, 2012
First Posted: May 3, 2012
Results First Submitted: June 8, 2017
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018