Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study

NCT01971359 | Completed DMC

• 1 other identifier: OSF-13-004
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study is determining the clinical outcomes, based on neurological testing, for the parafascicular minimally invasive clot evacuation technique. We will collect data from the time of surgery up until 90 days post procedure. We will also be looking at financial data as well.

• H(0): there is no economic benefit to the system with early surgical intervention for ICH
• Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical outcome with early surgical intervention (null hypotheses) H(0) is correct), the ability to accelerate the patients care from the entry point to the exit point will result in a significant economic advantage to the system through cost reduction.

Conditions

Intracerebral Hemorrhage

Keywords

Stroke, Intracerebral Hemorrhage, ICH

Outcome Measures

Primary Outcomes (1)

• 30-90 day outcomes

  The primary objective is to compare the 30 day and 90 day clinical outcomes of patients who will undergo parafascicular ICH-evacuation procedure compared to historical outcomes (surgical and non-surgical).

  30-90 days

Secondary Outcomes (1)

• Surgery success rates

  30-90 days

Other Outcomes (1)

• Financial outcomes

  30-90 days

Study Arms (1)

Retrospective

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that present with an ICH at OSF St. Francis Medical Center

You may qualify if:

• Consecutive patients aged at 18-80 presenting with an acute symptomatic supratertorial primary ICH diagnosed by CT
• Symptom onset to surgery \<24 hours (target \<8 hours)
• Glascow Coma Score \> 9
• Hematoma Volume, between 10ml and 50ml.
• Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)
• NIHSS of \>4 or deterioration determined by a neurologist.

You may not qualify if:

• Suspected secondary ICH
• Infratentorial ICH
• Isolated IVH
• Uncorrected coagulopathy
• Significant premorbid disability (mRS \>1)
• Hydrocephalus

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hepatitis, Infectious Canine

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; Hepatitis, Viral, Animal; Hepatitis, Animal; Infections; Adenoviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis; Liver Diseases; Digestive System Diseases; Dog Diseases; Animal Diseases

Study Officials

• Andrew Tsung, M.D.

  OSF Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrew Tsung M.D.

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

US (1)