Идёт набор NCT04521881

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

Фаза III С лечением Traumatic Brain Injury

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: Tranexamic Acid 500 MG.
Кому может быть актуально: Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 50 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: Великобритания
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

Intramuscular Tranexamic Acid for the Treatment of Symptomatic Mild Traumatic Brain Injury in Older Adults: a Randomised, Double-blind, Placebo-controlled Trial

Обзор

Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury

Подробное описание

TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.

Вмешательства

Препарат Tranexamic Acid 500 MG
given once as an intramuscular injection

Первичные конечные точки

Emergency department discharge [Срок оценки: within 24 hours]

Вторичные конечные точки (12)

Intracranial bleeding on CT scan [Срок оценки: within 48 hours]
Head injury related death [Срок оценки: within 48 hours]
All cause mortality [Срок оценки: within 28 days]
Disability [Срок оценки: within 28 days]
Global assessment of ability to self-care [Срок оценки: within 28 days]
Neurosurgery [Срок оценки: within 28 days]
Days in ICU [Срок оценки: within 28 days]
Re-admission to hospital [Срок оценки: within 28 days]
Vascular occlusive events [Срок оценки: within 28 days]
Seizures [Срок оценки: within 28 days]
Intramuscular injection site reaction [Срок оценки: within 28 days]
Pneumonia [Срок оценки: within 28 days]

Критерии участия

Критерии включения

50 years or older (actual or estimated)
History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
GCS ≥ 13
Has one or more of the following:

has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
nausea or vomiting
Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)
Not living in a nursing home, mental health institution or prison
Patient will be conveyed to or is admitted to a participating hospital