Recruitment

Recruitment Status
Withdrawn
Estimated Enrollment
140

Inclusion Criterias

Patients admitted within 4 days of symptom onset.
World Federation of Neurosurgeons scale score ≤ 2
Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
...
Patients admitted within 4 days of symptom onset.
World Federation of Neurosurgeons scale score ≤ 2
Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
Hunt and Hess Stroke scale score ≤ 2
All aneurysmal SAH patients with clinical and or radiological diagnosis.
The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
Subjects with age ≥18 years and ≤80 years at the time of screening.

Exclusion Criterias

Hunt and Hess Stroke scale scores > 2
Subject with age < 18 years and >80 years at the time of screening.
Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
...
Hunt and Hess Stroke scale scores > 2
Subject with age < 18 years and >80 years at the time of screening.
Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
The subject or legal representative is unable to provide informed consent.
Subjects who have hypersensitivity to acetazolamide, sulfa drugs, or any component of the formulation.
Time of symptom onset cannot be determined.
Subjects who have adrenocortical insufficiency.
Subject who is pregnant or lactating.
The subject has any end stage medical condition as determined by the principal investigator.
Any acute focal neurological deficit (including any one of these) speech problems, loss of vision, facial or extremity weakness.
World Federation of Neurosurgeons scale scores > 2
Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
Brain CT or MRI show acute infarction
Subjects with hepatic disease or insufficiency or cirrhosis.
The subject is medically unstable to participate in the trial as determined by the principal investigator.
Subjects with severe renal disease or dysfunction.

Summary

Conditions
  • Acute Cerebrovascular Accident
  • Vasospasm
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

If the subject decides to take part in this study, they will receive acetazolamide with standard of care or standard of care only for four days. This means: The subject will be given acetazolamide tablet orally with standard care for subarachnoid hemorrhage or standard of care only, for a maximum of...

If the subject decides to take part in this study, they will receive acetazolamide with standard of care or standard of care only for four days. This means: The subject will be given acetazolamide tablet orally with standard care for subarachnoid hemorrhage or standard of care only, for a maximum of 4 days. If the subject cannot take medication orally then the investigators will put a tube through the nose to stomach or small intestine. Being part of the study does not exclude the subject from receiving the standard therapy. The subject will be given the current standard of care therapy irrespective of being in the study or not. The investigators will review the subject's medical records and collect information from standard of care procedures that would have been done even if the subject were not enrolled in this study. This information will include, but will not be limited to, the subject's imaging data, sub arachnoid hemorrhage assessments and medical history. The subject's Hunt and Hess scale score and (World federation of neurologic surgeons) WFNS scale score will also be collected. Hunt and Hess and WFNS scale are used to assess the level of damage to neurologic functions of a person caused by sub arachnoid hemorrhage. The subject will be asked to come for the follow-up at 3 months after the discharge from the hospital. The following data will be obtained from each subject at 3-month follow-up. Modified Rankin Scale (m-RS) scores Glasgow Outcome Scale (GOS) scores

Inclusion Criterias

Patients admitted within 4 days of symptom onset.
World Federation of Neurosurgeons scale score ≤ 2
Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
...
Patients admitted within 4 days of symptom onset.
World Federation of Neurosurgeons scale score ≤ 2
Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
Hunt and Hess Stroke scale score ≤ 2
All aneurysmal SAH patients with clinical and or radiological diagnosis.
The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
Subjects with age ≥18 years and ≤80 years at the time of screening.

Exclusion Criterias

Hunt and Hess Stroke scale scores > 2
Subject with age < 18 years and >80 years at the time of screening.
Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
...
Hunt and Hess Stroke scale scores > 2
Subject with age < 18 years and >80 years at the time of screening.
Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
The subject or legal representative is unable to provide informed consent.
Subjects who have hypersensitivity to acetazolamide, sulfa drugs, or any component of the formulation.
Time of symptom onset cannot be determined.
Subjects who have adrenocortical insufficiency.
Subject who is pregnant or lactating.
The subject has any end stage medical condition as determined by the principal investigator.
Any acute focal neurological deficit (including any one of these) speech problems, loss of vision, facial or extremity weakness.
World Federation of Neurosurgeons scale scores > 2
Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
Brain CT or MRI show acute infarction
Subjects with hepatic disease or insufficiency or cirrhosis.
The subject is medically unstable to participate in the trial as determined by the principal investigator.
Subjects with severe renal disease or dysfunction.

Tracking Information

NCT #
NCT02165644
Collaborators
Not Provided
Investigators
  • Principal Investigator: Vishnumurthy S Hedna, MD University of Florida
  • Vishnumurthy S Hedna, MD University of Florida