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

Intracerebral Hemorrhage Clinical Trial

— MISPACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971359
• Other study ID #: OSF-13-004
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: May 18, 2016
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2016
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Patients will be recruited form the neurology and neurosurgery services at OSF Saint Francis Medical Center. Potential subjects will be identified by the study team which will include all investigators and study coordinators. For those patients who have had the Mi Space procedure, the study team will obtain the patients or patient's surrogate consent for clinical data of hospitalization and follow ups. A secured, de-identified log will be kept of all patients screened, and reasons for exclusion will be documented. Around 65% of unselected patients with ICH (not stratified by baseline predicted risk) have a documented 30 day composite outcome of death or dependency under medical management. Reviews of other types of minimally-invasive ICH surgeries provides data that significantly improved outcomes (meta-analysis odds ratio 0.54(0.39, 0.76)). An odds ratio of 0.54 shows a reduction in risk from 65% to about 50% (15% absolute reduction). Assuming the new procedure is at least as effective than current conventional management, 50 patients provides 66% surety that a 95% 1-sided confidence interval will exclude the chance that the new procedure is worse than medical management. Alternatively, a method of framing this, based on an exact one-sided binomial test of a one-sample proportion and an alpha level of 5%, is that a sample size of 50 patients provides approximately 66% surety/power that the new procedure is superior to medical management (i.e., lower than 65% suffering from death or poor functional outcomes). The critical computed value for this particular test, to provide some initial evidence of superiority, are observing no more than 26 patients (out of 50) suffering from death or dependency under the surgical procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Inclusion Criteria:

• 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.

Exclusion Criteria:

• Suspected secondary ICH

• Infratentorial ICH

• Isolated IVH

• Uncorrected coagulopathy

• Significant premorbid disability (mRS >1)

• Hydrocephalus

• Contraindication to safe surgical procedure as per neurosurgeon (justification for exclusion on this basis will be recorded)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
United States	OSF St. Francis Medical Center	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OSF Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Financial outcomes	We also will be looking at the financial aspect of current medical management and minimally invasive surgeries compared to the parafascicular technique.	30-90 days	No
Primary	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	No
Secondary	Surgery success rates	Another objective will be to describe and quantify peri-operative complications following the parafascicular ICH evacuation. We will assess the success rates of; atraumatic access to the hematoma, effective removal of fibrotic clot by measuring residual hematoma, the ability to achieve hemostasis intra-operatively, and to compare postoperative re-bleeding rates against residual clot volume.	30-90 days	No