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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®)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 patient was recruited for the study, however, they did not receive the intervention due to an AE

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Tissue Plasminogen Activator
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
   Tissue Plasminogen Activator 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   1 


  Outcome Measures

1.  Primary:   Symptomatic Intracranial Hemorrhage   [ Time Frame: 36 hours ]

2.  Secondary:   Pharmacokinetics of tPA   [ Time Frame: 24 hours ]

3.  Secondary:   Pharmacokinetics of tPA   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to lack of participant accrual.


  More Information

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
e-mail: calefond@seattlechildrens.org


Publications of Results:

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