Идёт набор NCT05649904

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

Без фазы С лечением Intraventricular Hemorrhage Subarachnoid Hemorrhage Subdural Hematoma Ventriculitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: IRRAflow with Active Fluid Exchange System, External Ventricular Drain.
Кому может быть актуально: Состояния в реестре: Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, Ventriculitis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

Обзор

The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD). Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.

Вмешательства

Устройство IRRAflow with Active Fluid Exchange System
IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care. The intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping t
Устройство External Ventricular Drain
The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Первичные конечные точки

Rate of revision procedures for the IRRAflow and EVD/Drainage catheters [Срок оценки: Immediately post-procedure]

Вторичные конечные точки (11)

Time to clearance of blood or bacterial mass as measured by head CT scan [Срок оценки: Immediately post-procedure]
Rate of catheter-related infection [Срок оценки: Immediately post-procedure]
Length of ICU stay [Срок оценки: Baseline]
Rate of shunt dependency [Срок оценки: Immediately post-procedure]
Indwell time of EVD/Drainage and IRRAflow Catheter [Срок оценки: Immediately post-procedure]
Functional Status - at inclusion and 30 days [Срок оценки: 30 days post subject discharge]
Mortality rates - intraprocedural and at 30 days [Срок оценки: 30 days post subject discharge]
Functional Status - at inclusion and 30 days [Срок оценки: 30 days post subject discharge]
Functional Status - at inclusion and 30 days [Срок оценки: 30 days post subject discharge]
Functional Status - at inclusion and 30 days [Срок оценки: 30 days post subject discharge]
Functional Status - at inclusion and 30 days [Срок оценки: 30 days post subject discharge]

Критерии участия

Критерии включения

Age ≥18 years of age
Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
Signed informed consent obtained by subject or Legally Authorized Representative