Potential eligibility for recombinant tissue plasminogen activator therapy in children: a population-based study

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.