Precision Use of TXA in Intracerebral Hemorrhage

Официальное название

PRECISion usE of TRANexamic Acid for Supratentorial Acute Cerebral Hemorrhage Trial: a Pilot Randomized Controlled Trial

Обзор

Primary Intracerebral hemorrhage (ICH) is a severe and disabling disease. The hematoma will expand within the first few hours, which contributes to increasing brain injury and worsening neurological prognosis. Hence, one of ICH's main acute therapeutic strategies is to reduce hematoma expansion (HE) with hemostatic agents like tranexamic acid (TXA) or recombinant factor VIIa. However, although most HE trials have demonstrated that treatment attenuated HE, they have largely been unable to demonstrate therapeutic benefit in improving functional outcomes. The lack of outcome benefits for ICH treatment is because therapeutic benefits are significantly confounded by the outcome heterogeneity based on ICH location and the variation in the degree of HE between patients, which is not accounted for in all ICH trials. The investigators' recent work has examined the interplay between ICH location and volume in determining ICH pathophysiology and outcomes, highlighting a critical interaction between these factors and neurological prognosis. Also, as HE only occurs in 15-40% of patients, the therapeutic benefits of treatment targeting HE are not modifiable in most patients. Furthermore, only a minority of patients with HE experienced neurological deterioration (HE-related neurological deterioration) that could impact their neurological outcomes. There is also a location-specific variation in the risk of HE-related neurological deterioration, occurring at a larger baseline volume for ICH at putamen/ lobar compared to thalamus/ internal capsule. Hence, as outcome heterogeneity based on ICH location and the variation in the degree of HE significantly confounds therapeutic effect, better patient selection for hemostatic agents in ICH treatment is essential to yield functional benefit. To address this, a novel selection criteria (\>7ml for thalamus/ internal capsule, \>30ml for putamen/ lobar) is proposed, which, in theory, would account for the confounding effect of location-specific outcome heterogeneity and the location-based variation in HE-related neurological deterioration. Therefore, the PRECISE-TRANSACT trial aims to investigate whether TXA administration based on this selection criteria significantly reduces the risk of neurological deterioration and consequent therapeutic benefit.

Вмешательства

• Препарат Tranexamic Acid (IV)
  TXA 1000mg stat over 10 minutes and 1000 mg over 8 hours

Первичные конечные точки

• Trial recruitment rate [Срок оценки: At recruitment]
• Trial retention rate [Срок оценки: Six months]

Вторичные конечные точки (4)

• The number of patients with early neurological deterioration [Срок оценки: 24 hours of admission]
• The number of patients with delayed neurological deterioration or any deterioration [Срок оценки: Day 2-7]
• Modified Rankin Scale [Срок оценки: Six months]
• Hematoma expansion [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• Primary ICH Diagnosis
• Age ≥ 18 years
• Within 6 hours of ICH
• Supratentorial ICH
• GCS ≥8
• Location-specific volume criteria (>7ml for thalamus or internal capsule; >30ml for putamen or lobar)

Критерии исключения

• Severe pre-morbid disability (Pre-morbid modified Rankin scale 5)
• Anticipated surgical treatment
• Recent acute atherosclerotic cardiovascular diseases (e.g. acute coronary syndrome, ischemic stroke)
• Receiving anticoagulation
• Recent intravascular stent placement and on dual antiplatelet treatment
• Expected life expectancy of <1 year
• Inability to participate in follow-up activity
• Bleeding tendency
• Severe renal impairment
• Severe liver impairment
• Known contraindication or allergy to tranexamic acid

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

Гонконг · 3 центра

• Pamela Youde Nethersole Eastern Hospital — Гонконг
• Prince of Wales Hospital — Гонконг
• The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07365150 · TKC202403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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