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
Last Update Posted
: May 3, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | May 1, 2012 | |||
First Posted Date ICMJE | May 3, 2012 | |||
Last Update Posted Date | May 3, 2017 | |||
Actual Study Start Date ICMJE | October 2012 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Symptomatic Intracranial Hemorrhage [ Time Frame: 36 hours ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01591096 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Thrombolysis in Pediatric Stroke (TIPS) | |||
Official Title ICMJE | Thrombolysis in Pediatric Stroke (TIPS) | |||
Brief Summary | Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of acute AIS. | |||
Detailed Description | OBJECTIVES:
TRIAL DESIGN: Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and dose-finding study of intravenous (IV) tPA in children with acute AIS to determine the maximal safe dose of intravenous (IV) tPA among three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of acute AIS. An adaptive dose finding method will be applied to escalate across the three dose levels within two age groups: 2-10 years (prepubertal) and 11-17 years. Dose will be escalated based on safety (absence of excess toxicity) with at least 3 children treated at each dose level. Intracranial hemorrhage following stroke can occur even in the absence of thrombolytic therapy, but the risk is increased by the use of thrombolytics. Primary endpoint toxicity is defined as SICH or severe hemorrhage within 36 hours of tPA administration, defined as any of the following:
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. TRIAL POPULATION: TIPS will enroll a maximum of 18 children age 2-10 years and maximum of 18 children age 11-17 years within 4.5 hours of the onset of acute AIS. On MRA or CTA they will have partial or complete occlusion of the artery, consistent with focal impairment of the arterial flow, that correlates with the clinical deficit. TIPS STUDY INTERVENTION: 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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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Stroke | |||
Intervention ICMJE | 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.
Other Name: Genentech as Activase® |
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Study Arms | Experimental: Tissue plasminogen activator
All patients will receive study drug.
Intervention: Drug: Tissue plasminogen activator (Activase®) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
1 | |||
Original Estimated Enrollment ICMJE |
36 | |||
Actual Study Completion Date | December 2013 | |||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | To be eligible for TIPS, a patient must meet the following Inclusion Criteria:
3.4.1.2.2. Patients with the following Exclusion Criteria will not be eligible for TIPS: Safety Related exclusion criteria:
Stroke related exclusions:
Neuro-imaging related exclusions:
Drug Related exclusions:
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Sex/Gender |
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Ages | 2 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01591096 | |||
Other Study ID Numbers ICMJE | 1R01NS065818( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Catherine Amlie-Lefond, Seattle Children's Hospital | |||
Study Sponsor ICMJE | Seattle Children's Hospital | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Seattle Children's Hospital | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |