Lumbar Drain vs Extraventricular Drain to Prevent Vasospasm in Subarachnoid Hemorrhage

NCT03065231 | Recruiting DMC FDA Device

• 1 other identifier: 160719
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Vasospasm is a common complication after rupture of intracranial aneurysms causing devastating neurologic deficits and death. Vasospasm has been directly associated with the amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and lumbar drain (LD) have been compared retrospectively yet remain controversial as to which method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would be a prospective randomized trial in which patients would be assigned to EVD or LD and observed to see if one method of intervention is associated with preventing clinical vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an optimal treatment modality to benefit all future patients with ruptured intracranial aneurysms.

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Vasopasm

  Clinical and Radiographic incidence of vasospasm after ruptured intracranial aneurysm

  0-14 days

Study Arms (2)

EVD

ACTIVE COMPARATOR

Patients will have extraventricular drain to manage CSF subarachnoid blood.

Device: Extraventricular Drain

LD

ACTIVE COMPARATOR

Patients will have lumbar drain to manage CSF subarachnoid blood.

Device: Lumbar Drain

Interventions

Extraventricular Drain DEVICE

As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.

EVD

Lumbar Drain DEVICE

LD

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence.

You may not qualify if:

• patients under the age of 18, excluding minors from this study

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

RECRUITING

Related Publications (8)

• Charpentier C, Audibert G, Guillemin F, Civit T, Ducrocq X, Bracard S, Hepner H, Picard L, Laxenaire MC. Multivariate analysis of predictors of cerebral vasospasm occurrence after aneurysmal subarachnoid hemorrhage. Stroke. 1999 Jul;30(7):1402-8. doi: 10.1161/01.str.30.7.1402.

  PMID: 10390314 BACKGROUND

• Kassell NF, Sasaki T, Colohan AR, Nazar G. Cerebral vasospasm following aneurysmal subarachnoid hemorrhage. Stroke. 1985 Jul-Aug;16(4):562-72. doi: 10.1161/01.str.16.4.562.

  PMID: 3895589 BACKGROUND

• Pluta RM, Hansen-Schwartz J, Dreier J, Vajkoczy P, Macdonald RL, Nishizawa S, Kasuya H, Wellman G, Keller E, Zauner A, Dorsch N, Clark J, Ono S, Kiris T, Leroux P, Zhang JH. Cerebral vasospasm following subarachnoid hemorrhage: time for a new world of thought. Neurol Res. 2009 Mar;31(2):151-8. doi: 10.1179/174313209X393564.

  PMID: 19298755 BACKGROUND

• Shishido T, Suzuki R, Qian L, Hirakawa K. The role of superoxide anions in the pathogenesis of cerebral vasospasm. Stroke. 1994 Apr;25(4):864-8. doi: 10.1161/01.str.25.4.864.

  PMID: 8160234 BACKGROUND

• Reilly C, Amidei C, Tolentino J, Jahromi BS, Macdonald RL. Clot volume and clearance rate as independent predictors of vasospasm after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Aug;101(2):255-61. doi: 10.3171/jns.2004.101.2.0255.

  PMID: 15309916 BACKGROUND

• Friedman JA, Goerss SJ, Meyer FB, Piepgras DG, Pichelmann MA, McIver JI, Toussaint LG 3rd, McClelland RL, Nichols DA, Atkinson JL, Wijdicks EF. Volumetric quantification of Fisher Grade 3 aneurysmal subarachnoid hemorrhage: a novel method to predict symptomatic vasospasm on admission computerized tomography scans. J Neurosurg. 2002 Aug;97(2):401-7. doi: 10.3171/jns.2002.97.2.0401.

  PMID: 12186469 BACKGROUND

• Maeda Y, Shirao S, Yoneda H, Ishihara H, Shinoyama M, Oka F, Sadahiro H, Ueda K, Sano Y, Kudomi S, Hayashi Y, Shigeeda T, Nakano K, Koizumi H, Nomura S, Fujii M, Nomura S, Suzuki M. Comparison of lumbar drainage and external ventricular drainage for clearance of subarachnoid clots after Guglielmi detachable coil embolization for aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2013 Jul;115(7):965-70. doi: 10.1016/j.clineuro.2012.10.001. Epub 2012 Oct 26.

  PMID: 23107165 BACKGROUND

• Klimo P Jr, Kestle JR, MacDonald JD, Schmidt RH. Marked reduction of cerebral vasospasm with lumbar drainage of cerebrospinal fluid after subarachnoid hemorrhage. J Neurosurg. 2004 Feb;100(2):215-24. doi: 10.3171/jns.2004.100.2.0215.

  PMID: 15086227 BACKGROUND

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the type of intervention that took place.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Clinical Chief of Neurosurgery

Model Details: There will be two arms of the study: patients randomly assigned to LD and patients randomly assigned to EVD. Randomization will account for Fisher Grade. The two treatment arms will have CSF diversion for 7 days. For patients treated with lumbar drain, patients will have CSF drainage of 10cc/hour for lumbar drain while patients treated with EVD at 15cm above the tragus.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 27, 2017
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)