Document Detail


Alteplase for the treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (The Cathflo Activase Pediatric Study).
MedLine Citation:
PMID:  17142704     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: Alteplase is approved for use in the restoration of function to occluded central venous access devices (CVADs); however, there are few prospective studies in children. This study was undertaken to evaluate the safety and efficacy of alteplase in the treatment of CVAD occlusions in a pediatric population. MATERIALS AND METHODS: A prospective, multicenter, open-label, single-arm study evaluating a maximum of two doses (< or =2 mg per dose) of alteplase was performed in pediatric patients. Inclusion criteria included patient age less than 17 years with an occluded CVAD (single-, double-, and triple-lumen catheter or implanted port). Patients with hemodialysis catheters, those with known mechanical occlusion, or those considered at high risk for bleeding or embolization were excluded. Assessment of function was made 30 and 120 minutes (if required) after each dose. The primary objective of the study was to evaluate the safety of alteplase as measured by the incidence of intracranial hemorrhage (ICH); secondary objectives included the evaluation of specific targeted serious adverse events and efficacy of alteplase in the restoration of catheter function. RESULTS: A total of 310 patients (174 male patients, 136 female patients; mean age, 7.2 years; range, 0.04-18.3 y) were treated; 55 of the patients (17.7%) were younger than 2 years of age. No patients experienced ICH (95% CI, 0%-1.2%). Nine serious adverse events were noted in eight patients (2.6% incidence), two of which were attributed by the investigator to study drug administration (one case of sepsis and one case of a ruptured catheter lumen). The cumulative rate of restoration of CVAD function after serial administration of a maximum of two instillations of alteplase, each with a maximum dwell time of 120 minutes, was 82.9% (95% CI, 78.2%-86.9%). Similar rates of catheter function restoration were seen among all catheter types studied; there were no clinically meaningful differences among age or sex subgroups. CONCLUSION: The administration of alteplase is safe and effective for the restoration of function to CVADs in pediatric patients.
Authors:
Martha Blaney; Violet Shen; John A Kerner; Brian R Jacobs; Sarah Gray; Jennifer Armfield; Charles P Semba;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  17     ISSN:  1051-0443     ISO Abbreviation:  J Vasc Interv Radiol     Publication Date:  2006 Nov 
Date Detail:
Created Date:  2006-12-04     Completed Date:  2007-03-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1745-51     Citation Subset:  IM    
Affiliation:
Department of Vascular Medicine, Genentech, South San Francisco, CA 94080, USA.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Catheterization, Central Venous / adverse effects*,  instrumentation
Child
Child, Preschool
Equipment Failure
Fibrinolytic Agents / therapeutic use*
Humans
Infant
Patient Selection
Prospective Studies
Safety
Tissue Plasminogen Activator / therapeutic use*
Tomography, X-Ray Computed
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; EC 3.4.21.68/Tissue Plasminogen Activator

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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