Degradation of the Glycocalyx in Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage

NCT03706768 | Unknown

• 1 other identifier: 170016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide novel information to the literature base for the pathophysiology of aneurysmal subarachnoid hemorrhage. The association of breakdown products in the serum of aSAH patients were reported in a very small case series of 3 patients, as mentioned above. However, while their results are intriguing and encouraging, our study will provide more definitive information about the GC in aSAH. If there is a positive correlation, the results of this study will guide future investigations into new therapies for this devastating disease such as MMP inhibition with doxycycline.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Syndecan-1 and heparin sulfate

  Compare the degree of glycocalyx breakdown in patients with aSAH who develop delayed cerebral ischemia (DCI) to those that do not develop DCI. This will be completed by measuring the breakdown of Syndecan-1 and heparin sulfate in the blood.

  day 0 through day 13

Secondary Outcomes (2)

• serum Matrix metalloproteinase-1 and Matrix metalloproteinase-9

  day 0 through day 13

• urinary microalbumin-to-creatinine ratio (MACR)

  day 0 through day13

Study Arms (1)

Glycocalyx

OTHER

degree of glycocalyx breakdown in patients with aSAH

Other: Glycocalyx

Interventions

Glycocalyx OTHER

Measure Degradation of the Glycocalyx

Glycocalyx

Eligibility Criteria

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

You may qualify if:

• Age 18 years of age and older
• Cerebral aneurysm on CT-angio

You may not qualify if:

• comfort care only orders,
• the absence of an aneurysm on CT-angiography,
• onset of aneurysm rupture \> 24 hours,
• and inability to obtain informed consent from patient or family pregnant women

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

Related Publications (28)

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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

Study Officials

• Daniel Theodore, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia E Birk

CONTACT

434-924-2283; meb2w@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Aneurysmal Subarachnoid Hemorrhage

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)