Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage

Intraventricular Rt-PA Pharmacokinetic and Pharmacodynamic Study


Patrocinador principal: Johns Hopkins University

Fuente FDA Office of Orphan Products Development
Resumen breve

This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

Descripción detallada

IVH occurs in about 40 percent of intracerebral hemorrhage cases and 15 percent of aneurysmal subarachnoid hemorrhage cases. Evidence supports a strong contribution of IVH to morbidity and mortality after cerebral hemorrhage. External ventricular drainage (EVD) is required clinical management; however, EVD via intraventricular catheter alone fails to prevent much of the morbidity and mortality of IVH. This study seeks to demonstrate the safety and efficacy of intraventricular thrombolysis, using rt-PA, as a method of removing this blood and altering morbidity and mortality. Patients will receive intraventricular injections of rt-PA or placebo every 12 hours. They will be followed prospectively with daily head CT scans during the acute-treatment phase and again between Days 28 and 32.

Completion date provided represents the completion date of the grant per OOPD records

Estado general Completed
Fecha de inicio September 2001
Fecha de Terminación September 2004
Fase Phase 2
Tipo de estudio Interventional
Inscripción 30

Tipo de intervención: Drug

Nombre de intervención: Recombinant Tissue Plasminogen Activator (rt-PA)



Inclusion criteria:

- Intraventricular hemorrhage (IVH) confirmed by CT scan

- More than 12 hours post bleed

- Hematoma size stable by CT scan

- Post-IVH catheter CT scan

- Able to begin study within 24 hours of bleed

Exclusion criteria:

- Infratentorial bleed

- Supratentorial bleed greater than 30 cc

- Unclipped aneurysm suspected

- Arteriovenous malformation suspected

- Any severe, complicating illness (e.g., AIDS or DNR)

- Cardiovascular parameters that could confound study (e.g., myocardial infarction, pulmonary emboli, systemic fibrinolysis)

- Active internal bleeding

- Requirement for heparin doses greater than 10,000 U/day

- Concurrent coumadin

- Known allergy to rt-PA

- Pregnancy

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Instalaciones: The Johns Hopkins University
Ubicacion Paises

United States

Fecha de verificación

December 2001

Palabras clave
Condición Examinar
Información de diseño del estudio

Asignación: Randomized

Propósito primario: Treatment

Enmascaramiento: Double