Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
NCT ID: NCT05131295
Last Updated: 2021-11-23
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
49 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-09-05
Study Completion Date
2009-03-10
Brief Summary
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Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect, making it widely available. Its neuroprotective effects have been found through its glutamate receptors antagonistic effect. Their main objective was to study the neuroprotective properties in patients with aneurysmal subarachnoid hemorrhage and high-risk factors for the development of cerebral vasospasm. Both the placebo and the dapsone used in this clinical trial were provided by the institution's neurochemistry laboratory.
Detailed Description
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A prospective, analytical, randomized, double-blinded, placebo-controlled clinical trial was realized. Participants suffering from aneurysmal subarachnoid hemorrhage (SAH), matching the inclusion criteria, were randomly assigned using a computer-derived table to receive from admission to the 15th day post-ictus an oral dose of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100mg per day. A nasogastric tube was used in participants with unpaired consciousness. All patients underwent aneurysm clipping or obliteration employing endovascular coils. Both groups received the standard of care (which included oral nimodipine from admission until the 21st post-ictal day, normovolemia, and dextran), and if required, vasogenic amines and/or cerebral intra-arterial administration of nimodipine in cases of cerebral vasospasm.
The participants' characteristics were assessed before the randomization process in both groups. The clinical severity was classified by the World Federation of Neurological Surgeons (WNFS), and the amount of subarachnoid blood on CT was evaluated using the Fisher scale. Patients were evaluated during their stay to look for the appearance of DCI and were followed for at least three months to evaluate their clinical outcome using the modified Rankin Scale (mRS). Severe adverse events such as methemoglobinemia and other less severe effects that forced treatment discontinuation were also assessed.
Data were analyzed according to a defined prospective plan. The primary endpoint was the incidence of DCI during the first 21 days post-SAH.
The projected sample size was 50 patients, guaranteeing a power of 80% (error β 0.2) to detect a statistically significant difference between placebo and dapsone with an accepted two-tailed α error of 0.05. The sample size was calculated assuming an incidence of DCI in the placebo group of 45% and the dapsone group of 10%, making a difference of 35% between groups.
The clinical outcome at three months and the presence of infarction on CT at patient discharge were analyzed as secondary outcomes.
Categorical variable data is presented as incidences and compare groups using the χ2 test or Fisher's exact test (when any of the cells had less than five patients). Continuous variables are presented as means and standard deviation (SD). The statistical test for these variables was the Student's t-test or nonparametric tests such as the Mann-Whitney U test.
Statistical significance with a p-value \<0.05 was established and the SPSS statistical package (version 23.0) was used to perform the analysis.
The participants' characteristics were assessed before the randomization process in both groups. The clinical severity was classified by the World Federation of Neurological Surgeons (WNFS), and the amount of subarachnoid blood on CT was evaluated using the Fisher scale. Patients were evaluated during their stay to look for the appearance of DCI and were followed for at least three months to evaluate their clinical outcome using the modified Rankin Scale (mRS). Severe adverse events such as methemoglobinemia and other less severe effects that forced treatment discontinuation were also assessed.
Data were analyzed according to a defined prospective plan. The primary endpoint was the incidence of DCI during the first 21 days post-SAH.
The projected sample size was 50 patients, guaranteeing a power of 80% (error β 0.2) to detect a statistically significant difference between placebo and dapsone with an accepted two-tailed α error of 0.05. The sample size was calculated assuming an incidence of DCI in the placebo group of 45% and the dapsone group of 10%, making a difference of 35% between groups.
The clinical outcome at three months and the presence of infarction on CT at patient discharge were analyzed as secondary outcomes.
Categorical variable data is presented as incidences and compare groups using the χ2 test or Fisher's exact test (when any of the cells had less than five patients). Continuous variables are presented as means and standard deviation (SD). The statistical test for these variables was the Student's t-test or nonparametric tests such as the Mann-Whitney U test.
Statistical significance with a p-value \<0.05 was established and the SPSS statistical package (version 23.0) was used to perform the analysis.
Conditions
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Subarachnoid Hemorrhage
Brain Ischemia
Subarachnoid Hemorrhage, Aneurysmal
Aneurysmal Subarachnoid Hemorrhage
Delayed Cerebral Ischemia
Vasospasm, Cerebral
Keywords
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Dapsone
Cerebral vasospasm
Delayed cerebral ischemia
Subarachnoid hemorrhage
Aneurysms
Neuroprotective effect
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients were randomly assigned using a computer-derived table to receive from admission to the 15th-day post-ictus an oral dose of 2.5 ml/24 hours of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100 mg (2.5 ml/24 hours). In patients with unpaired consciousness a nasogastric tube was used. Treatment was initiated during the first five days post-ictus and continued until day 15. All patients underwent aneurysm clipping by microsurgery or obliteration employing endovascular coils; postoperatively, both groups received the usual prophylaxis (which included oral nimodipine from admission until day 21 post-ictus, normovolemia, and dextran) and/or treatment (which included the use of vasogenic amines and, in refractory cases, cerebral intra-arterial administration of nimodipine) of cerebral vasospasm.
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Dapsone
Besides the standard of care, those assigned to the dapsone group received orally 100mg (2.5 ml) of dapsone suspension daily, from the admission day until the 15th-day post-ictus.
Group Type
EXPERIMENTAL
Dapsone
Intervention Type
DRUG
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect. It has an anti-inflammatory effect due to its inhibitory action on neutrophils. Neuroprotective effects have been found experimentally with the use of dapsone, predominantly through its glutamate receptors antagonistic effect; these are the main receptors involved in neuronal excitotoxicity.
Placebo
Besides the standard of care, those assigned to the placebo group received orally 2.5 ml of aluminum hydroxide gel daily, from the admission day until the 15th-day post-ictus.
Group Type
PLACEBO_COMPARATOR
Aluminum Hydroxide Gel
Intervention Type
DRUG
Aluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach
Interventions
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Dapsone
Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect. It has an anti-inflammatory effect due to its inhibitory action on neutrophils. Neuroprotective effects have been found experimentally with the use of dapsone, predominantly through its glutamate receptors antagonistic effect; these are the main receptors involved in neuronal excitotoxicity.
Intervention Type
DRUG
Aluminum Hydroxide Gel
Aluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Participants presented with aneurysmal subarachnoid hemorrhage.
* Candidates to aneurysm occlusion.
* Fisher scale grade III or IV.
* Candidates to aneurysm occlusion.
* Fisher scale grade III or IV.
Exclusion Criteria
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Anemia at admission.
* Known allergy to sulfones or sulfas.
* Severe systemic disease (renal or hepatic failure).
* Anemia at admission.
* Known allergy to sulfones or sulfas.
* Severe systemic disease (renal or hepatic failure).
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Edgar Nathal, MD
Role: PRINCIPAL_INVESTIGATOR
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Locations
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El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Mexico City, , Mexico
Site Status
Countries
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Mexico
References
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Other Identifiers
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35/07
Identifier Type: -
Identifier Source: org_study_id