Lumbar Drainage of Intraventricular Hemorrhage
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: External drainage of intraventricular hemorrhage.
- Кому может быть актуально
- Состояния в реестре: Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage. 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
- Германия
- 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
Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
Обзор
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.
Вмешательства
- Другое External drainage of intraventricular hemorrhage
An EVD is required to be eligible for the DRAIN IVH study. Weaning from the EVD is at the discretion of the local investigators. Imaging is at discretion of local investigators. Use, timing and frequency of fibrinolysis via EVD is at local discretion, too.
Первичные конечные точки
- Rate of mRS [Срок оценки: 180 days (+/- 14 days)]
Вторичные конечные точки (8)
- Amount of CSF drained by external ventricular drain [Срок оценки: up to 14 days (duration of hospital stay)]
- Amount of CSF drained by lumbar drain [Срок оценки: up to 14 days (duration of hospital stay)]
- Need for VP shunt [Срок оценки: up to 14 days (duration of hospital stay)]
- Need for VP shunt [Срок оценки: at 180 days]
- Clearance of intraventricular blood (via neuroimaging with CT or MRI) [Срок оценки: up to 14 days (duration of hospital stay)]
- Clearance of intraventricular blood (via neuroimaging with CT or MRI) [Срок оценки: up to 14 days (duration of hospital stay)]
- Bacterial Ventriculitis/Meningitis leading to antibiotic treatment [Срок оценки: up to 14 days (duration of hospital stay)]
- Mortality [Срок оценки: up to 14 days (duration of hospital stay) and 6 month]
Критерии участия
Критерии включения
- ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus
- Age ≥ 18 y
- Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well
Критерии исключения
- Premorbid mRS score > 2
- Pregnancy
- Life expectancy <6 months
- Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures.
- Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
- Other clear contraindication for treatment with a lumbar drain
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Германия · 12 центров
- Department of Neurology, University Hospital Heidelberg — Heidelberg
- LMU München — München
- Augsburg University Hospital — Augsburg
- Charite Universitätsmedizin Berlin — Berlin
- Düsseldorf Universitiy Hospital — Düsseldorf
- Frankfurt University Hospital — Frankfurt
- Goettingen University Hospital — Göttingen
- Augsburg University Hospital Department of Neurosurgery — Heidelberg
- … и ещё 4 центра
Публикации
- Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. do PMID 27888608
- Staykov D, Huttner HB, Struffert T, Ganslandt O, Doerfler A, Schwab S, Bardutzky J. Intraventricular fibrinolysis and lumbar drainage for ventricular hemorrhage. Stroke. 2009 Oct;40(10):3275-80. doi: 10.1161/STROKEAHA.109.551945. Epub 2009 Aug 13. PMID 19679848
- Kuramatsu JB, Gerner ST, Ziai W, Bardutzky J, Sembill JA, Sprugel MI, Mrochen A, Kolbl K, Ram M, Avadhani R, Falcone GJ, Selim MH, Lioutas VA, Endres M, Zweynert S, Vajkoczy P, Ringleb PA, Purrucker JC, Volkmann J, Neugebauer H, Erbguth F, Schellinger PD, Knappe UJ, Fink GR, Dohmen C, Minnerup J, Reichmann H, Schneider H, Rother J, Reimann G, Schwarz M, Bazner H, Classen J, Michalski D, Witte OW, PMID 35521958
- Chen M, Sauer LD, Herweh C, Sander A, Klose C, Wick W, Wolf S, Schonenberger S. Lumbar drainage in intracerebral haemorrhage with intraventricular haemorrhage (DRAIN IVH): protocol for a multi-centre, randomised-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2026 May 4;11(5):aakag046. doi: 10.1093/esj/aakag046. PMID 42132469
Идентификаторы
NCT: NCT06510842 · DRAIN IVH · S-304/2024