Safety and Feasibility of a Lower Dose Intravenous TPA Therapy for Ischemic Stroke beyond the First Three Hours

Vol. 19, No. 4, 2005

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Original Paper

Safety and Feasibility of a Lower Dose Intravenous TPA Therapy for Ischemic Stroke beyond the First Three Hours
Ken Uchino^b, Andrei V. Alexandrov^a, Zsolt Garami^a, Ashraf El-Mitwalli^a, Lewis B. Morgenstern^c, James C. Grotta^a

^aStroke Program, Department of Neurology, University of Texas-Houston Medical School, Houston, Tex.;
^bUPMC Stroke Institute, University of Pittsburgh, Pittsburgh, Pa., and
^cStroke Program, University of Michigan Health System, and the Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Mich., USA

Address of Corresponding Author

Cerebrovasc Dis 2005;19:260-266 (DOI: 10.1159/000084090)

Key Words

Thrombolysis
Stroke
Safety
Tissue plasminogen activator

Abstract

Background: The most common reason that patients do not receive intravenous tissue plasminogen activator (TPA) is the inability to meet the strict 3-hour treatment window. The risk/benefit ratio is more unfavorable beyond this time, but some patients might still benefit. We designed a pilot study with the hypothesis that lower dose TPA might be safe in selected patients treated beyond 3 h. Subjects and Methods: To determine the range of symptomatic hemorrhage and good outcome, we prospectively gave IV TPA 0.6 mg/kg up to 60 mg (15% bolus, 85% infusion over 30 min) to patients with ischemic stroke beyond the first 3 h after last known to be normal. Other eligibility criteria were: NIH Stroke Scale 4, normal head CT scan, and clinical suspicion or transcranial Doppler (TCD) evidence of a proximal arterial occlusion. Results: 28 patients were treated, median age 65 (range 24-88) years, median baseline NIHSS score 18 (range 7-34) points. TPA bolus was given 372 ± 158 min after stroke onset (range 189-720). Symptomatic hemorrhage occurred in 3/28 (11%) patients, including 1 fatal bleed. Overall mortality was 6/28 (21%). Partial or complete recanalization was found in 8/20 (40%) TCD monitored patients within 2 h after TPA bolus. Early major improvement occurred in 4/28 (14%) patients. Conclusions: Lower dose IV TPA in patients presenting beyond 3 h carries a risk of intracerebral hemorrhage. However, recanalization with dramatic recovery can still occur.

Author Contacts

Ken Uchino, MD
UPMC Stroke Institute
200 Lothrop Street, PUH C-400
Pittsburgh, PA 15213 (USA)
Tel. +1 412 647 2052, Fax +1 412 647 8445, E-Mail uchinok@upmc.edu

Article Information

Received: June 9, 2004
Accepted: November 7, 2004
Published online: February 22, 2005
Number of Print Pages : 7
Number of Figures : 0, Number of Tables : 1, Number of References : 47

Medline Abstract (ID 15731557)

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