A Phase 2 interventional study of Acetazolamide and Nimodipine in Acute Cerebrovascular Accident and Vasospasm, sponsored by University of Florida. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-09-24.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
Subarachnoid Hemorrhage (SAH) can occur commonly in the setting of trauma or brain aneurysm. SAH accounts for 10% of all the strokes. Aneurysmal SAH accounts for 80 % of cases of non-traumatic cases of SAH, 6-8% of all strokes and 22-25% of all cerebrovascular deaths. Mortality can be 50% in the first few years of aneurysmal SAH rupture, 15% are severely disabled post SAH and only 20-35% having a moderate to good recovery it has gained lot of attention and pre-clinical and clinical trials of various agents have been tried to prevent poor outcome. The United States epidemiology data reveals the fact that 1% to 5% of adults have unruptured brain aneurysm and 30,000 people suffer from aneurysm rupture annually translating to brain aneurysm rupture every 18 minutes.
Vasospasm is the most common SAH complication post 24 hours. It is the segmental or diffuse narrowing of the vessels especially the large vessels. Fifty percent of those patients who develop clinical vasospasm, progress to infarction and 15-20% will advance to disabling stroke or die of cerebral ischemia. The present treatment modalities are insufficient to prevent vasospasm. So, we need new treatment modalities to decrease the mortality and morbidity in SAH patients.
The investigators hypothesize that Acetazolamide administration can prevent development of vasospasm after aneurysmal SAH.
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
Browse Subarachnoid Hemorrhage studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Acetazolamide 250 mg QID oral for 4 days along with current standard of care which is Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days. If the drug can't be given orally, then feeding tube (NG Tube or DHT) will be used for drug administration.
Drug: Acetazolamide · Drug: Nimodipine
Subjects will receive only standard of care for subarachnoid hemorrhage which will include Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days.
Drug: Nimodipine
Acetazolamide 250 mg QID oral for 4 days along with standard of care which includes Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days. If the drug can't be given orally, then feeding tube (NG Tube or DHT) will be used for drug administration.
Also known as: Diamox
Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days
Also known as: Nimotop
Modified Rankin Score
The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke including subarachnoid hemorrhage. The score is given according to following scale. 0- No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Time frame: At 3 months from the baseline
Neurological examination of the subject
Neurological status of a subject is assessed by physical neurological examination of the subject by a qualified neurologist. It is one of the most important aspect in determining neurological health of a subject after subarachnoid hemorrhage. It also helps to determine subarachnoid hemorrhage severity and prognosis.
Time frame: Baseline, 10 days, 3 months
Glasgow Outcome Score
The Glasgow Outcome Scale (GOS) was developed to rank outcomes after head injury, but has been used in stroke studies including subarachnoid hemorrhage. The score is given according to following scale ranging from 1-5. 1. Death- Severe injury or death without recovery of consciousness 2. Persistent vegetative state- Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions 3. Severe disability- Severe injury with permanent need for help with daily living 4. Moderate disability- No need for assistance in everyday life, employment is possible but may require special equipment. 5. Low disability- Light damage with minor neurological and psychological deficits.
Time frame: At 3 months from the baseline
Hunt and Hess Scale
The Hunt and Hess scale, is one of the grading systems used to classify the severity of a subarachnoid hemorrhage based on the patient's clinical condition. It is used as a predictor of patient's prognosis/outcome, with a higher grade correlating to lower survival rate. It gives an index of the mortality associated with the various grades. The mortality is minimum with grade 1 and maximum with grade 5. The grades are as follows: 1. Asymptomatic, mild headache, slight nuchal rigidity 2. Moderate to severe headache, nuchal rigidity, no neurologic deficit other than cranial nerve palsy 3. Drowsiness / confusion, mild focal neurologic deficit 4. Stupor, moderate-severe hemiparesis 5. Coma, decerebrate posturing
Time frame: Baseline, 10 days
World Federation of Neurosurgeons Scale
The World Federation of Neurosurgeons (WFNS) classification uses Glasgow coma score (GCS) and focal neurological deficit to gauge severity of symptoms. It is intended to be a simple, reliable and clinically valid way to grade a patient with subarachnoid hemorrhage. The prognosis becomes worse when we move from grade 1 to grade 5. Grade 1 represents a GCS of 15 with absent focal neurological deficit, Grade 2 represents a GCS of 13-14 with absent focal neurological deficit, Grade 3 represents a GCS of 13-14 with focal neurological deficit present, Grade 4 represents a GCS of 7-12 with present or absent focal neurological deficit, Grade 5 represents a GCS of \<7 with present or absent focal neurological deficit.
Time frame: Baseline, 10 days
No study locations are listed for this record.
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Florida