Ventriculostomies in SAH: ICP Open or Not?

NCT00787020 | Completed Results

• 1 other identifier: Pro00005900
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Conditions

Subarachnoid Hemorrhage

Keywords

Cerebrospinal Fluid; Ventriculostomy; Subarachnoid hemorrhage; vasospasm; Human Subjects

Outcome Measures

Primary Outcomes (1)

• Cerebral Artery Vasospasm

  Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

  14 days

Secondary Outcomes (2)

• External Ventricular Drain (EVD) Complications

  14 Days

• Cerebrospinal Fluid (CSF) Output Per Day

  14 Days

Study Arms (2)

Ventriculostomy Open

Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by positioning the stopcock in the open position and the intracranial pressure (ICP) is monitored once each hour: CSF drains into an external ventricular drainage bag.

Ventriculostomy Monitored

Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subarachnoid hemorrhage

You may qualify if:

• Clinical diagnosis of subarachnoid hemorrhage
• Age 18 years or older
• Ventriculostomy in situ

You may not qualify if:

• Prisoners
• Glasgow coma score = 3

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Kim GS, Amato A, James ML, Britz GW, Zomorodi A, Graffagnino C, Zomorodi M, Olson DM. Continuous and intermittent CSF diversion after subarachnoid hemorrhage: a pilot study. Neurocrit Care. 2011 Feb;14(1):68-72. doi: 10.1007/s12028-010-9401-y.

  PMID: 20596794 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: DaiWai M Olson
• Organization: Duke University Medical Center

Olson006@mc.duke.edu

9196683751

Study Officials

• DaiWai M Olson, PhD RN

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 7, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 3, 2015
• Results First Posted: December 17, 2010

Record last verified: 2011-03

Locations

US (1)