RESUMO
We evaluated the efficacy and safety of alteplase to restore central venous line (CVL) patency in a consecutive cohort study. A uniform, weight-dependent protocol for alteplase administration was established prospectively. For children < or =10 kg, a dose of 0.5 mg was used; for children >10 kg, doses of 1 to 2 mg were used. The alteplase remained instilled for 1 to 4 hours or overnight. Retrospective data accrual found that 25 children received alteplase for a total of 34 courses; 29 (85%) of the 34 courses of alteplase completely restored CVL patency. Alteplase appears to be a safe and effective thrombolytic agent for CVL patency restoration in children.
Assuntos
Cateterismo Venoso Central , Fibrinolíticos/uso terapêutico , Ativador de Plasminogênio Tecidual/uso terapêutico , Criança , Estudos de Coortes , Feminino , Fibrinolíticos/administração & dosagem , Humanos , Masculino , Estudos Prospectivos , Ativador de Plasminogênio Tecidual/administração & dosagemRESUMO
OBJECTIVE: Low molecular weight heparins (LMWHs) offer several advantages over standard anticoagulant therapy (unfractionated heparin/warfarin) including predictable pharmacokinetics, minimal monitoring, and subcutaneous administration. Our objective was to determine the safety and efficacy of LMWHs in children. METHODS: A prospective cohort of children treated with the LMWH enoxaparin (Rhone Poulenc Rorer) was monitored at the Hospital for Sick Children, Toronto, Canada, from March 1994 until July 1997. RESULTS: There were 146 courses of LMWH administered for treatment and 31 courses for prophylaxis of thromboembolic events (TEs). Clinical resolution of TEs occurred in 94% of children receiving therapeutic doses of LMWH, and 96% of children receiving prophylactic doses of LMWH had no symptoms of recurrent or new TEs. Major bleeding occurred in 5% of children receiving therapeutic doses. Recurrent or new TEs occurred in 1% and 3% of children receiving therapeutic and prophylactic doses of LMWH, respectively. CONCLUSION: LMWH appears to be efficacious and safe for both management and prophylaxis of TEs. The results of this cohort study justify a randomized controlled trial comparing LMWH with standard therapy for the management of TEs in children.
Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Adolescente , Anticoagulantes/efeitos adversos , Criança , Pré-Escolar , Estudos de Coortes , Enoxaparina/efeitos adversos , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Estudos Prospectivos , Método Simples-Cego , Tromboembolia/tratamento farmacológico , Tromboembolia/mortalidade , Tromboembolia/prevenção & controle , Resultado do TratamentoRESUMO
OBJECTIVE: To compare low-molecular-weight preparations of heparin (LMWH) with standard heparin in children requiring anticoagulant treatment for thromboembolic disease. METHODS: We treated 25 children who required heparin, but were at significant risk of bleeding, with LMWH (enoxaparin, Rhone-Poulenc Rorer). The median age was 4 years (range, newborn to 17 years), with nine infants less than 2 months of age. Fourteen children had a deep vein thrombosis or pulmonary embolism, nine had thrombotic complications in the central nervous system, and two had complex congenital heart disease, for which they received prophylaxis at a lower dosage (0.5 mg/kg given subcutaneously twice a day). The remaining 23 children received an initial dose of 1 mg/kg, every 12 hours subcutaneously, with subsequent doses adjusted to achieve a 4-hour anti-factor Xa level between 0.5 and 1.0 unit/ml. RESULTS: Newborn infants had increased dose requirements; an average of 1.60 units/kg was required to achieve therapeutic heparin levels. For the remaining children, the initial dose of 1.0 mg/kg was sufficient. After the initial dose adjustment, LMWH was administered with twice-weekly monitoring. The median duration of therapy with LMWH was 14 days. Two children with previously documented gastrointestinal ulcers bled and required transfusion therapy. Therapy with LMWH was continued without further events. There were no new thrombotic events during the treatment with LMWH. The cost of administering LMWH compared with heparin was reduced by 30% because of decreased laboratory monitoring, blood sampling times, intravenous starts, and nursing time. Needle punctures were reduced with LMWH therapy by the placement of a subcutaneous catheter. CONCLUSION: These results provide the basis for a randomized, controlled trial comparing LMWH with standard heparin in pediatric patients.
Assuntos
Anticoagulantes/administração & dosagem , Enoxaparina/administração & dosagem , Embolia Pulmonar/tratamento farmacológico , Trombose/tratamento farmacológico , Adolescente , Anticoagulantes/economia , Anticoagulantes/farmacocinética , Testes de Coagulação Sanguínea , Estudos de Casos e Controles , Cateteres de Demora , Criança , Pré-Escolar , Custos e Análise de Custo , Relação Dose-Resposta a Droga , Enoxaparina/economia , Enoxaparina/farmacocinética , Feminino , Heparina/administração & dosagem , Heparina/economia , Heparina/farmacocinética , Humanos , Lactente , Recém-Nascido , Masculino , Projetos Piloto , Fatores de Risco , Fatores de TempoRESUMO
We prospectively evaluated a capillary whole blood prothrombin time (PT) monitor (Biotrack, Ciba Corning) in an outpatient pediatric anticoagulation clinic (40 clinic patients) and in age-matched healthy subjects (30 control subjects). Subsequently, 23 children requiring warfarin therapy were placed on a home program (home patients) using the PT monitor; their parents were trained and the results followed by clinic staff. The PT results were reported as internationalized normalized ratios (INRs). The laboratory and PT-monitor INR values were similar for the clinic patients and the control subjects (y = 0.76x + 0.38; r = 0.93; p < 0.001). The accuracy of the PT monitor (the difference between INR values and the laboratory INR) was best at an INR of 2.5 to 3.5; 90% of paired INR values were within 0.8 INR units. The average duration of monitoring for home patients was 13 months (range, 2 to 60 months). They had an average of 3 dose measurements (range, 1 to 11 measurements) and 1.8 dose changes (range, 0.6 to 4.5 changes) per month. Of the 599 measurements, 63% were within the therapeutic range, similar to those for clinic patients; the dose requirements were also similar. There was 1 significant bleeding event, a subdural hematoma in a patient with an INR of 4.1, and 1 catheter-related thrombotic event with an INR of 1.2; both children recovered. Of the 23 families, one discontinued home monitoring because of parental discomfort, 2 children died of their primary disease, 6 completed warfarin therapy, and 14 remain on the home program. We conclude that the whole blood PT/INR monitor is safe and offers practical advantages to children requiring anticoagulation.
Assuntos
Monitoramento de Medicamentos/métodos , Assistência Domiciliar/métodos , Tempo de Protrombina , Varfarina/administração & dosagem , Adolescente , Pré-Escolar , Monitoramento de Medicamentos/instrumentação , Monitoramento de Medicamentos/estatística & dados numéricos , Estudos de Avaliação como Assunto , Feminino , Assistência Domiciliar/estatística & dados numéricos , Humanos , Lactente , Modelos Lineares , Masculino , Educação de Pacientes como Assunto , Estudos ProspectivosRESUMO
We performed a cross-sectional evaluation of deep vein thrombosis (DVT) related to the use of central venous lines (CVLs) in all pediatric patients receiving home total parenteral nutrition at our institution (N = 12). All children (5 months to 17 years of age) were examined with bilateral upper limb venography. All CVLs were flushed daily with heparin (200 units). At the time of evaluation, 49 CVLs had been placed in the 12 children. Of the 39 CVLs removed, 27 (66%) were blocked; venograms had not been previously obtained except of one child. Eight children had clinical evidence of superficial collateral circulation in the upper portion of the chest and the upper extremities; five had intermittent symptoms of superior vena cava obstruction. On venography, 8 of the 12 children had extensive evidence of DVT; two were unilateral and six bilateral. Five children were treated with warfarin (0.12 to 0.28 mg/kg per day) to achieve an international normalized ratio of 1.4 to 1.8. Neither bleeding nor further CVL-related DVT has occurred. We conclude that the risk of CVL-related DVT in children requiring home total parenteral nutrition is high, and that venography should be performed early in the event of CVL blockage. A multicenter, controlled trial assessing optimal warfarin therapy in this patient population is indicated.