The Intra-arterial Vasospasm Trial
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Vasospasm
Intervention: Nicardipine (Drug); Verapamil (Drug); Nicardipine + Verapamil + Nitroglycerin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s): Peng R Chen, MD, Principal Investigator, Affiliation: University of Texas Medical School at Houston Ketan R Bulsara, MD, Principal Investigator, Affiliation: Yale School of Medicine
Overall contact: Peng R Chen, MD, Phone: 713-704-7100, Email: Peng.R.Chen@uth.tmc.edu
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.
Clinical Details
Official title: The Intra-arterial Vasospasm Trial- A Multi-center Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research
Primary outcome: Post infusion improvement ratio(PIIR)
Secondary outcome: To grade clinical outcome using Modified Rankin score
Detailed description:
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.
This study is a prospective multicenter randomized trial. The primary outcome measure is the
Post infusion improvement ratio (PIIR) assessed 10 minutes after completion of the
intra-arterial infusion. PIIR is a measure of arterial lumen diameter pre and post
intra-arterial drug infusion in the presenting vasospasmic blood vessel.
Modified Rankin score (mRS) at 3 months post hospital discharge will be recorded as a
secondary outcome to assess clinical outcome.
The interventions in this study are a part of routine standard of care (SOC) procedures for
cerebral vasospasm treatment. Following surgical or endovascular intervention for aneurysmal
Subarachnoid Hemorrhage (aSAH) if patients develop cerebral vasospasm refractory to maximal
medical management, endovascular treatment by intra-arterial drug infusion of single drug
agent or cocktail drug agents will be initiated.
Study participants will be randomly assigned to one of the three treatment groups where one
single drug agent or cocktail drug agents will be intra-arterially administered. Pre & post
infusion vasospasmic vessel diameters will be compared. The change in diameter will be
quantified based on the mean percentage change. Three months post hospital discharge, study
participants will be followed up in clinic to evaluate clinical outcome.
The study will require 330 patients in total. The patient population will be hospitalized
patients presenting with cerebral vasospasm post aneurysmal subarachnoid hemorrhage.
Subjects will be stratified by randomization into 3 treatment groups.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Peng R Chen, MD, Phone: 713-704-7100, Email: Peng.R.Chen@uth.tmc.edu
Yale School of Medicine, New Haven, Connecticut 06520, United States; Recruiting Ketan R Bulsara, MD, Phone: 203-737-2096, Email: ketan.bulsara@yale.edu Ketan R Bulsara, MD, Principal Investigator
University of Illinois College of Medicine at Chicago, Chicago, Illinois 60612, United States; Not yet recruiting Ali Alaraj, MD, Phone: 312-996-4842, Email: alaraj@uic.edu Ali Alaraj, MD, Principal Investigator
Mayo Clinic, Rochester, Minnesota 55905, United States; Not yet recruiting Guiseppe Lanzino, MD, Phone: 507-284-2511, Email: Lanzino.Guiseppe@mayo.edu Guiseppe Lanzino, MD, Principal Investigator
Washington University School of Medicine in St. Louis, St. Louis, Missouri 63110, United States; Not yet recruiting Colin P Derdeyn, MD, Phone: 314-362-5580, Email: derdeync@mir.wustl.edu Colin P Derdeyn, MD, Principal Investigator
University of Buffalo, Buffalo, New York 14203, United States; Not yet recruiting Adnan H Siddiqui, MD, Phone: 716-218-1000, Email: adnan.h.siddiqui@gmail.com Adnan H Siddiqui, MD, Principal Investigator
Wake Forest University Health Sciences, Winston - Salem, North Carolina 27157, United States; Not yet recruiting Stacey Wolfe, MD, Phone: 336-716-3842, Email: sqwolfe@wakehealth.edu Wendy Jenkins, Phone: 336.716.3842, Email: mailto:wejenkin@wakehealth.edu
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Not yet recruiting Bradley Bohnstedt, MD, Phone: 405-271-4912, Email: mailto:Bradley-Bohnstedt@ouhsc.edu
Geisinger Clinic, Danville, Pennsylvania 17822, United States; Not yet recruiting Clemens Schirmer, MD Tejal Raichura, Phone: 570.214.6084, Email: taraichura@geisinger.edu
Temple University, Philadelphia, Pennsylvania 19140, United States; Not yet recruiting Kadir Erkmen, MD, Phone: 617-697-4722, Email: Kadir.Erkmen@tuhs.temple.edu Kathleen Hatala, Email: Kathleen.Hatala@tuhs.temple.edu
Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Not yet recruiting Pascal M Jabbour, MD, Phone: 215-955-7000, Email: Pascal.Jabbour@jefferson.edu Pascal M Jabbour, MD, Principal Investigator
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States; Not yet recruiting Andrew F Durcruet, MD, Phone: 412-864-1839, Email: ducruetaf@upmc.edu Andrew F Ducruet, MD, Principal Investigator
University of Texas Medical School at Houston, Houston, Texas 77030, United States; Recruiting Peng R Chen, MD, Phone: 713-704-7100, Email: peng.r.chen@uth.tmc.edu Aditya A Sanzgiri, MBBS MPH, Phone: 713-704-7263, Email: Aditya.A.Sanzgiri@uth.tmc.edu Peng R Chen, MD, Principal Investigator
Additional Information
Related publications: Dorsch NW, King MT. A review of cerebral vasospasm in aneurysmal subarachnoid haemorrhage Part I: Incidence and effects. J Clin Neurosci. 1994 Jan;1(1):19-26. Treggiari MM, Walder B, Suter PM, Romand JA. Systematic review of the prevention of delayed ischemic neurological deficits with hypertension, hypervolemia, and hemodilution therapy following subarachnoid hemorrhage. J Neurosurg. 2003 May;98(5):978-84. Review. Erratum in: J Neurosurg. 2003 Dec;99(6):1119. Biller J, Godersky JC, Adams HP Jr. Management of aneurysmal subarachnoid hemorrhage. Stroke. 1988 Oct;19(10):1300-5. Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. Review. Keuskamp J, Murali R, Chao KH. High-dose intraarterial verapamil in the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2008 Mar;108(3):458-63. doi: 10.3171/JNS/2008/108/3/0458. Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35. Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26. Pierot L, Aggour M, Moret J. Vasospasm after aneurysmal subarachnoid hemorrhage: recent advances in endovascular management. Curr Opin Crit Care. 2010 Apr;16(2):110-6. doi: 10.1097/MCC.0b013e3283372ef2. Review. Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.
Starting date: April 2014
Last updated: August 3, 2015
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