The Intra-arterial Vasospasm Trial

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm.

We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy.

All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Brigham and Women's Hospital; Geisinger Clinic; Lenox Hill Hospital; Mayo Clinic; Northwell Health; Temple University; Thomas Jefferson University; University at Buffalo; University of Illinois at Chicago; University of Michigan; Wake Forest University Health Sciences; Yale University
• Treatments: Nicardipine; Nitroglycerin; Verapamil

Criteria

Inclusion Criteria:

• Adult patient, age 18-80 years old, with ruptured aneurysm(s) who experience cerebral vasospasm post operatively within 3-21 days.

Exclusion Criteria:

• Inability to obtain consent from patient or patients kin

• Pregnant women

• less than 18 years of age of more than 80 years of age

• Hunt Hess Grade 5 SAH