A Phase 4 interventional study of Acetazolamide in Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, Cerebral, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Diagnostic
Among 149 studies in Subarachnoid Hemorrhage with a site in United States — 31 open to participants now, 37 under way, 2 of them phase 3. Subarachnoid Hemorrhage · United States.
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, this one is the 80th largest by enrollment of the 107 interventional ones that give a count, is one of 7 that started in 2019, is one of 17 in phase 4, and was the 92nd registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
Browse Subarachnoid Hemorrhage studies →31 of the 149 studies in Subarachnoid Hemorrhage with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States, Brazil, Canada and 2 more countries
Daniel Raper, MBBS · Sites in United States
University of Louisville · Sites in United States
University of Florida · Sites in United States
Marshall Holland · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
149 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 33 · Phase 3 11 · Phase 4 17
First in 1999; this study’s year is marked. 7 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Median enrollment 30 across the 107 interventional studies, 60 across the 42 observational. Of the 94 that completed or were terminated, 38 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
23 of 149 have an industry lead sponsor. The 10 most frequent:
University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
University of Wisconsin, Madison has 2 studies filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
14 of the studies in Subarachnoid Hemorrhage with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06621329Phase 3University of California, DavisTransnasal Sphenopalatine Ganglion Block for Treatment of Acute Subarachnoid Hemorrhage Associated Headache | 2027-07 |
| NCT07116408Wright State UniversityIntranasal Sphenopalatine Ganglion Blockade for Headaches Following Aneurysmal Subarachnoid Hemorrhage | 2026-11 |
| NCT06103201University of Maryland, BaltimoreHyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury | 2026-11-26 |
| NCT05230134Stanford UniversityCervical Sympathetic Block in Patients With Cerebral Vasospasm | 2026-12 |
| NCT06119061Aaron CookTelavancin Blood and Cerebrospinal Fluid Concentrations in Patients With External Ventricular Drainage | 2026-12 |
Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral autoregulation at a time when it has not yet caused clinically apparent signs or symptoms. 30 participants will be enrolled at the University of Wisconsin - Madison and can expect to be on study for about 2 weeks.
Acetazolamide or vasodilatory challenge should identify subjects having a abnormal cerebrovascular reactivity capacity. More specifically, after receiving the drug there will not be the expected increase in cerebral blood flow (CBF) in some of the subjects because they are already suffering from a disturbance in the vasculature's ability to respond to the signal for vasodilation. The investigators believe the presence of this deficit will be helpful in identifying patients who are at risk for potential brain ischemia due to this decreased capacity to autoregulate if/when clinically significant vasospasm occurs. The investigators predict that acetazolamide-activated regional cerebral blood flow studies will be more sensitive in the detection of mild cerebral vasospasm and will not just detect changes in cerebral blood flow as does standard perfusion imaging, but will provide information regarding changes in cerebrovascular reactivity. Under these circumstances, a better predictor of those patients at risk of cerebral infarction due to delayed vasospasm would be delineated. Identifying this "high-risk cohort" prior to the onset of clinically apparent symptoms would result in the institution of preventative measures such as triple H therapy.
The objective of this proposal is to conduct a feasibility study of acetazolamide activated C-arm cone beam CT perfusion (CBCTP) to determine its application in the prediction of symptomatic cerebral vasospasm (i.e. ischemia or stroke) in patients with aneurysmal subarachnoid hemorrhage. The initial plan is to obtain C-arm CBCTP pre- and post-intravenous infusion of 1g acetazolamide within 24 hours of symptom onset in aneurysmal subarachnoid hemorrhage patients. The hypothesis is that some of these patients that will later develop clinical vasospasm of a degree sufficient to cause cerebral ischemia. The investigators believe this cohort of patients will demonstrate altered cerebrovascular reactivity during the acetazolamide challenge at a time before there is either angiographic evidence of vasospasm or clinical evidence of abnormal perfusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants entered into the study as a cohort, will because of their participation, undergo only two additional digital subtraction angiogram (DSA) imaging acquisitions. These will be done in conjunction with their standard diagnostic DSA evaluation and consist of two CBCTPs, one before and one after administration of 1 g acetazolamide through a peripheral IV line. Each CBCTP will require administration of 75-100 mL iodinated contrast medium also through an intravenous line. Neither of these imaging studies will be used for clinical decision making, but would be processed and evaluated at later date for a formal analysis of the results. Following completion of diagnostic imaging subjects will receive the usual standard of care for treatment of their ruptured aneurysm i.e. endovascular embolization or open surgical clipping.
Drug: Acetazolamide
1 g acetazolamide through a peripheral IV line
Also known as: Diamox
Number of Participants Who Develop Delayed Cerebral Vasospasm
Clinical neurological deterioration not attributable to other causes, mores specifically not due to re-bleeding, hydrocephalus, or metabolic changes.
Time frame: Day 1-14 during the hospitalization
Relative Percent Change in Cerebral Blood Flow
The data that will be statistically compared is the pre-diamox perfusion in comparison to the post-diamox perfusion. A statistically significant change increase in CBF represents an appropriate response to Diamox. Lack of change in CBF or decrease in CBF could be suggestive of potential for developing vasospasm.
Time frame: pre and post perfusion during imaging procedure, up to an hour
Percent Change in Left Hemisphere Brain Imaging Maps
Using perfusion map values, relative percent change will be calculated
Time frame: pre and post perfusion during imaging procedure, up to an hour
Percent Change in Right Hemisphere Brain Imaging Maps
Using perfusion map values, relative percent change will be calculated
Time frame: pre and post perfusion during imaging procedure, up to an hour
Participants were recruited from July 2019 to April 2022.
| Milestone | Acetazolamide Challenge |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
Clinical neurological deterioration not attributable to other causes, mores specifically not due to re-bleeding, hydrocephalus, or metabolic changes.
| Participants | Acetazolamide Challenge |
|---|---|
| Number of Participants Who Develop Delayed Cerebral Vasospasm | 2 |
The data that will be statistically compared is the pre-diamox perfusion in comparison to the post-diamox perfusion. A statistically significant change increase in CBF represents an appropriate response to Diamox. Lack of change in CBF or decrease in CBF could be suggestive of potential for developing vasospasm.
| percent change | Acetazolamide Challenge |
|---|---|
| Relative Percent Change in Cerebral Blood Flow | 20.722 ± 13.967 |
Using perfusion map values, relative percent change will be calculated
| percent change | Acetazolamide Challenge |
|---|---|
| Percent Change in Left Hemisphere Brain Imaging Maps | 19.785 ± 13.488 |
Using perfusion map values, relative percent change will be calculated
| percent change | Acetazolamide Challenge |
|---|---|
| Percent Change in Right Hemisphere Brain Imaging Maps | 21.659 ± 15.046 |
Collected over Days 1-14 during hospitalization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acetazolamide Challenge | 1/11 (9.1%) | 2/11 (18.2%) | 1/11 (9.1%) |
| Event | Acetazolamide Challenge |
|---|---|
| CardiomyopathyCardiac disorders | 1/11 |
| External Ventricular Drainage infectionNervous system disorders | 1/11 |
| HydrocephalusNervous system disorders | 1/11 |
| Event | Acetazolamide Challenge |
|---|---|
| Pulmonary edemaRespiratory, thoracic and mediastinal disorders | 1/11 |
| Age, Customized(Participants) | Acetazolamide Challenge |
|---|---|
| 30-39 years | 2 |
| 40-49 years | 0 |
| 50-59 years | 3 |
| 60-69 years | 3 |
| 70-79 years | 3 |
| Sex: Female, Male(Participants) | Acetazolamide Challenge |
|---|---|
| Female | 7 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Acetazolamide Challenge |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Acetazolamide Challenge |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Acetazolamide Challenge |
|---|---|
| United States | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in Jul 2022, 35 months.
Results were first posted in Jul 2023, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. 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.
Studies of the drug tested here: Acetazolamide
University of Wisconsin, Madison →