Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage
Last updated on April 2022Recruitment
- Recruitment Status
- Withdrawn
- Estimated Enrollment
- 140
Inclusion Criteria
- Patients admitted within 4 days of symptom onset.
- All aneurysmal SAH patients with clinical and or radiological diagnosis.
- Subjects with age ≥18 years and ≤80 years at the time of screening.
- ...
- Patients admitted within 4 days of symptom onset.
- All aneurysmal SAH patients with clinical and or radiological diagnosis.
- Subjects with age ≥18 years and ≤80 years at the time of screening.
- Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
- The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
- World Federation of Neurosurgeons scale score ≤ 2
- Hunt and Hess Stroke scale score ≤ 2
Exclusion Criteria
- Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
- Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
- Subjects with hepatic disease or insufficiency or cirrhosis.
- ...
- Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
- Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
- Subjects with hepatic disease or insufficiency or cirrhosis.
- Subject who is pregnant or lactating.
- Any acute focal neurological deficit (including any one of these) speech problems, loss of vision, facial or extremity weakness.
- Brain CT or MRI show acute infarction
- The subject has any end stage medical condition as determined by the principal investigator.
- Subject with age < 18 years and >80 years at the time of screening.
- The subject is medically unstable to participate in the trial as determined by the principal investigator.
- Time of symptom onset cannot be determined.
- World Federation of Neurosurgeons scale scores > 2
- The subject or legal representative is unable to provide informed consent.
- Hunt and Hess Stroke scale scores > 2
- Subjects who have adrenocortical insufficiency.
- Subjects with severe renal disease or dysfunction.
- Subjects who have hypersensitivity to acetazolamide, sulfa drugs, or any component of the formulation.
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 Criteria
- Patients admitted within 4 days of symptom onset.
- All aneurysmal SAH patients with clinical and or radiological diagnosis.
- Subjects with age ≥18 years and ≤80 years at the time of screening.
- ...
- Patients admitted within 4 days of symptom onset.
- All aneurysmal SAH patients with clinical and or radiological diagnosis.
- Subjects with age ≥18 years and ≤80 years at the time of screening.
- Mean velocities of < 200 cm/s in at least 1 vascular axis of the circle of Willis
- The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.
- World Federation of Neurosurgeons scale score ≤ 2
- Hunt and Hess Stroke scale score ≤ 2
Exclusion Criteria
- Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
- Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
- Subjects with hepatic disease or insufficiency or cirrhosis.
- ...
- Subjects who have decreased sodium and/or potassium levels; hyperchloremic acidosis.
- Mean velocities of ≥ 200 cm/s in at least 1 vascular axis of the circle of Willis
- Subjects with hepatic disease or insufficiency or cirrhosis.
- Subject who is pregnant or lactating.
- Any acute focal neurological deficit (including any one of these) speech problems, loss of vision, facial or extremity weakness.
- Brain CT or MRI show acute infarction
- The subject has any end stage medical condition as determined by the principal investigator.
- Subject with age < 18 years and >80 years at the time of screening.
- The subject is medically unstable to participate in the trial as determined by the principal investigator.
- Time of symptom onset cannot be determined.
- World Federation of Neurosurgeons scale scores > 2
- The subject or legal representative is unable to provide informed consent.
- Hunt and Hess Stroke scale scores > 2
- Subjects who have adrenocortical insufficiency.
- Subjects with severe renal disease or dysfunction.
- Subjects who have hypersensitivity to acetazolamide, sulfa drugs, or any component of the formulation.
Tracking Information
- NCT #
- NCT02165644
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Vishnumurthy S Hedna, MD University of Florida
- Vishnumurthy S Hedna, MD University of Florida