drugset / Trial / NCT01591096
Thrombolysis in Pediatric Stroke (TIPS)
Phase 1
Terminated
1 enrolled
Seattle Children's Hospital
Alberta Children's Hospital · collabMcMaster University · collabMedical College of Wisconsin · collabThe Hospital for Sick Children · collabUniversity of Texas at Austin · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2012-10
- Primary completion
- 2013-12
- Completion
- 2013-12
Publications
- Results Rivkin MJ, deVeber G, Ichord RN, Kirton A, Chan AK, Hovinga CA, Gill JC, Szabo A, Hill MD, Scholz K, Amlie-Lefond C. Thrombolysis in pediatric stroke study. Stroke. 2015 Mar;46(3):880-5. doi: 10.1161/STROKEAHA.114.008210. Epub 2015 Jan 22. No abstract available.
- Results Bernard TJ, Rivkin MJ, Scholz K, deVeber G, Kirton A, Gill JC, Chan AK, Hovinga CA, Ichord RN, Grotta JC, Jordan LC, Benedict S, Friedman NR, Dowling MM, Elbers J, Torres M, Sultan S, Cummings DD, Grabowski EF, McMillan HJ, Beslow LA, Amlie-Lefond C; Thrombolysis in Pediatric Stroke Study. Emergence of the primary pediatric stroke center: impact of the thrombolysis in pediatric stroke trial. Stroke. 2014 Jul;45(7):2018-23. doi: 10.1161/STROKEAHA.114.004919. Epub 2014 Jun 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 0.75 mg/kg | Intravenous |
| Subject | Alteplase | Protein / enzyme biologic | 0.9 mg/kg | Intravenous |
| Subject | Alteplase | Protein / enzyme biologic | 1 mg/kg | Intravenous |