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Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

11 de enero de 2011 actualizado por: University of California, San Diego

Phase 1 Study of Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke

The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator (tPA) within 6 hours of stroke onset when combined with hypothermia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)-a naturally occurring protein that opens blocked arteries by dissolving blood clots-activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.

The Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset, but not for those who arrive at the hospital more than 3 hours after stroke onset.

Researchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging. In particular, hypothermia may make it possible to use tPA later than 3 hours after a stroke begins. This study will determine if it is safe to use tPA within 6 hours of the start of a stroke when combined with hypothermia.

Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.

Participants will be randomly assigned to a study group based on when their stroke began. Those who arrive at the hospital less than 3 hours from stroke onset will receive tPA alone or tPA with cooling (hypothermia). Those who arrive at the hospital 3 to 6 hours after stroke onset will be assigned to 1 of 4 groups-receiving either tPA alone, tPA with cooling, cooling alone, or standard medical care. Length of participation (including observation after the patient leaves the hospital) is 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

130

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Medical Center
      • San Diego, California, Estados Unidos, 92103
        • Scripps Mercy Hospital
      • San Diego, California, Estados Unidos, 92037
        • University of California San Diego, Thornton Hospital
      • San Diego, California, Estados Unidos, 92103
        • University of California San Diego, Hillcrest Medical Center
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06102
        • Hartford Hospital
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Saint Louis University Medical Center
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Herman Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 18 to 80
  • All eligibility criteria for t-PA administration for acute ischemic stroke as outlined by the NINDS tPA Guidelines are met with the exception of time from onset
  • Stroke onset within 6 hours prior to planned start of tPA
  • Any subtype of ischemic stroke with NIHSS < 7 at the time hypothermia begins

Exclusion Criteria:

  • Etiology other than ischemic stroke
  • Item 1a on NIHSS>1 at the time of enrollment
  • Symptoms resolving or NIHSS < 7 at the time hypothermia begins
  • Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis, (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans.
  • Known co-morbid conditions likely to complicate therapy, e.g., end-stage cardiomyopathy, uncompensated arrhythmia, myopathy, liver disease severe enough to elevate bilirubin, history of pelvic or abdominal mass likely to compress inferior vena cava, IVC filters, dementia severe enough to prevent valid consent, end-stage AIDS, known thyroid deficiency, known renal insufficiency likely to impair meperidine (Demerol®) clearance
  • Intracerebral hematoma
  • Any intraventricular hemorrhage
  • SBP > 185 or < 100; DBP > 110 or < 50 mmHg
  • Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
  • Medical conditions likely to interfere with patient assessment
  • Known allergy to meperidine (Demerol®)
  • Currently taking MAO-I class of medication or used within previous 14 days
  • Life expectancy < 3 months
  • Not likely to be available for long-term follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group 1
Groups 1 and 2: Parallel groups, randomized to hypothermia or no hypothermia. Both groups receive tPA as a part of standard of care.
Droga: tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Comparador activo: Group 2
Groups 1 and 2: Parallel groups, randomized to hypothermia or no hypothermia. Both groups receive tPA as a part of standard of care.
Droga: tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Procedimiento: hypothermia

Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.

Subjects are stratified by time to six groups.
Sin intervención: Group 3
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
Comparador activo: Group 4
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
Droga: tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Comparador activo: Group 5
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
Procedimiento: hypothermia

Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.

Subjects are stratified by time to six groups.
Comparador activo: Group 6
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
Droga: tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Procedimiento: hypothermia

Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.

Subjects are stratified by time to six groups.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Incidence and volume of hemorrhage on CT
Periodo de tiempo: 48 hours post onset
48 hours post onset

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Incidence of AE and SAE
Periodo de tiempo: 90 days post onset
90 days post onset
Mortality in both groups testing whether hypothermia improves mortality after stroke
Periodo de tiempo: 90 Day
90 Day
NIHSS at the end of hypothermia
Periodo de tiempo: Hour 23.5 +/- 30 minutes of hypothermia
Hour 23.5 +/- 30 minutes of hypothermia
Modified Rankin and NIHSS
Periodo de tiempo: 30 and 90days
30 and 90days
CT lesion volume
Periodo de tiempo: 30 days
30 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of California, San Diego

Colaboradores

National Institute of Neurological Disorders and Stroke (NINDS)

Investigadores

  • Investigador principal: Patrick Lyden, MD, University of California San Diego, Stroke Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2003

Finalización primaria (Actual)

1 de octubre de 2008

Finalización del estudio (Actual)

1 de mayo de 2009

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2006

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2006

Publicado por primera vez (Estimar)

27 de enero de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de enero de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

11 de enero de 2011

Última verificación

1 de enero de 2009

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • P50NS44148LYDEN

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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