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Potential eligibility for recombinant tissue plasminogen activator therapy in children: a population-based study
Laura L Lehman1, Dawn O Kleindorfer, Jane C Khoury
1Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. Laura.Lehman@cchmc.org
Insights
Few children with ischemic stroke meet eligibility criteria for recombinant tissue plasminogen activator therapy. This finding highlights challenges in recruiting for pediatric stroke clinical trials, suggesting a need for multicenter collaboration.
Area of Science:
- Pediatric Neurology
- Stroke Medicine
- Clinical Trial Design
Background:
- Intravenous recombinant tissue plasminogen activator (rt-PA) is a proven treatment for adult ischemic stroke.
- Currently, no established thrombolytic therapy exists for acute ischemic stroke in children.
- Pediatric stroke research is limited by a lack of eligibility data for existing treatments.
Purpose of the Study:
- To determine the eligibility rates for rt-PA therapy in pediatric ischemic stroke patients.
- To inform the planning and design of future pediatric stroke clinical trials.
- To estimate the potential number of eligible children for rt-PA therapy in the U.S.
Main Methods:
- A population-based study identified 29 pediatric ischemic stroke cases across three time periods (1993-1994, 1999, 2005).
- Eligibility for rt-PA was assessed using the 2007 American Heart Association guidelines for adults.
- Analysis considered varying interpretations of contraindication criteria.
Main Results:
- Eligibility for rt-PA ranged from 3% to 10% (1 to 3 cases) among identified pediatric ischemic strokes.
- Extrapolation based on national incidence suggests up to 178 children annually in the U.S. might be eligible.
- Recruitment for pediatric stroke trials is anticipated to be difficult.
Conclusions:
- The low eligibility rate for rt-PA in children presents a significant challenge for clinical trial recruitment.
- A collaborative, multicenter approach is essential for successful pediatric stroke clinical studies.
- Further research is needed to establish effective treatments for pediatric ischemic stroke.
Abstract:
Intravenous recombinant tissue plasminogen activator is an established therapy for adults with ischemic stroke. In this Greater Cincinnati/Northern Kentucky population-based study, 8% were eligible. However, no established therapy exists for children with acute ischemic stroke. Accordingly, investigators assessed rates of eligibility for recombinant tissue plasminogen activator therapy among children (<18 years of age) in the same population to aid planning of future clinical trials. The investigators identified 29 pediatric ischemic strokes during 3 separate study periods (1993-1994, 1999, and 2005) and determined potential eligibility for recombinant tissue plasminogen activator therapy based on 2007 American Heart Association guidelines for adults. Depending on how relative contraindications were considered, 1 to 3 cases (3%-10%) met eligibility criteria. On the basis of national pediatric stroke incidence rates extrapolated from our population, it is estimated that up to 178 children might be eligible for intravenous recombinant tissue plasminogen activator therapy annually in the United States. Thus, recruitment for clinical studies is likely to be challenging and requires a concerted multicenter effort.
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