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Acetazolamide as a treatment after hemorrhagic stroke


- candidate number26807
- NTR NumberNTR6680
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2017
- Secondary IDsNL60301.041.17 // 17/234 protocol ID // METC
- Public TitleAcetazolamide as a treatment after hemorrhagic stroke
- Scientific TitleAcetazolamide in Aneurysmal Subarachnoid Hemorrhage
- ACRONYMASH
- hypothesisIn a phase II study we will evaluate safety and proof-of-concept of acetazolamide in patients with aneurysmal SAH. The primary aim of this study is to evaluate whether acetazolamide improves cerebral perfusion as measured with magnetic resonance imaging (MRI) performed 7±2 days after ictus.
- Healt Condition(s) or Problem(s) studiedAneurysm, Subarachnoid hemorrhage (SAH)
- Inclusion criteria≥18 years old
Aneurysm confirmed by the presence of subarachnoid blood by computed tomography (CT) or lumbar puncture and by visualization of the aneurysm on either CT angiography, MR angiography or digital subtraction angiography
Hospital arrival ≤72 hours of ictus
Eligible for aneurysm coiling
- Exclusion criteriaIntensive care (IC) required for >72 hours after ictus (i.e., during inclusion window)
Perimesencephalic bleeding
Traumatic SAH
Severe liver dysfunction or severe renal dysfunction
Allergic reaction for sulfomides
Any contraindication for MR imaging (e.g. metal objects within or around the body)
Pregnancy or women who are breastfeeding
Addison’s disease
Phenytoin use
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-mei-2019
- Target number of participants40
- InterventionsIn the intervention group, subjects will receive acetazolamide intravenously as well as treatment as usual. The dosage of acetazolamide will be similar to the average dosage used for the treatment of intracranial hypertension: 1.5 grams per day in three dosages of 0.5 grams in a 100 mL solution per dose. The intervention will be initiated within 72 hours after ictus, after aneurysm securing, and it will be continued until day 14 after ictus in addition to the usual treatment. The control group will not receive any study medication and will only receive treatment as usual.
- Primary outcomeCerebral perfusion (arterial spin labeling (ASL) MRI) on day 7±2 after ictus.
- Secondary outcomeCerebral perfusion (arterial spin labeling (ASL) MRI) on day 12±2 after ictus.
Serious adverse events (SAEs) and serious unexpected serious adverse reactions (SUSARs) until 10 weeks after ictus.
The occurrence of DCI. DCI will be defined as either “clinical deterioration or cerebral infarction due to delayed cerebral ischemia”.
- Timepointsday 7±2 after ictus, day 12±2 after ictus, 10 weeks after ictus
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Lisa van der Kleij
- CONTACT for SCIENTIFIC QUERIES Lisa van der Kleij
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryApproximately 30% of patients with subarachnoid hemorrhage (SAH) suffer from delayed cerebral ischemia (DCI). This in-hospital complication increases the risk of poor functional outcome. The only available drug that reduces the risk of DCI is nimodipine. However, the effect of nimodipine is only modest. Acetazolamide, a carbonic anhydrase inhibitor, could be a useful additional drug for the prevention of DCI by acting on 3 different pathways: (1) it increases cerebral blood flow via vasodilation, (2) it decreases brain edema through carbonic anhydrase inhibition, and (3) it decreases cerebrospinal fluid production. These combined actions of acetazolamide make it a promising drug for the prevention of DCI in patients with SAH. In a phase II study we will evaluate safety and proof-of-concept of acetazolamide in patients with aneurysmal SAH. The primary aim of this study is to evaluate whether acetazolamide improves cerebral perfusion as measured with magnetic resonance imaging (MRI) performed 7±2 days after ictus. The secondary objectives of this study are to investigate (1) the safety of acetazolamide when given until day 14 after aneurysmal SAH (aSAH), (2) whether acetazolamide improves cerebral perfusion also at day 12±2 after ictus, (3) whether the proportion of patients with DCI is lower in the intervention group. The tertiary objectives of this study are: (1) to investigate whether acetazolamide improves the Quality of Life score and modified Rankin Scale (degree of disability) at 10 weeks after SAH, and (2) to examine whether the proportion of patients with hydrocephalus is lower in the intervention group.
- Main changes (audit trail)
- RECORD2-mrt-2017 - 12-sep-2017


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