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Carbonic Anhydrase Antagonism in Subarachnoid Hemorrhage

NCT02165644 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-24

No results posted yet for this study

Summary

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.

Conditions

  • Acute Cerebrovascular Accident
  • Vasospasm

Interventions

DRUG

Acetazolamide

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.

DRUG

Nimodipine

Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Vishnumurthy S Hedna, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165644 on ClinicalTrials.gov