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NCT01591096 · ClinicalTrials.gov registry record · Phase 1
Thrombolysis in Pediatric Stroke (TIPS)
A Phase 1 study, sponsored by Seattle Children's Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01591096: Clinical Trial Phase 1 study, sponsored by Seattle Children's Hospital.
NCT01591096 is a Phase 1 study that was terminated before completion, run by Seattle Children's Hospital. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591096, a Phase 1 study, was terminated before completion, sponsored by Seattle Children's Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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 trans
Interventions
- DRUG Tissue plasminogen activator (Activase®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Why NCT01591096 stopped before completion
NCT01591096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Tissue plasminogen activator (Activase®) is the first listed.
NCT01591096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591096 about?
NCT01591096 is a clinical study titled "Thrombolysis in Pediatric Stroke (TIPS)". 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...
What is the current status of trial NCT01591096?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01591096?
The interventions under investigation include: Tissue plasminogen activator (Activase®) (DRUG).
Who is sponsoring clinical trial NCT01591096?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01591096's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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