ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH) (ENRICH)

Overview

About this study

The purpose of this study is to provide clinical evidence of functional improvement, safety, and economic benefit when comparing intracerebral hemorrhage (ICH) evacuation surgery to medical treatment.

 

.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18-80 years
  • Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
  •  ICH volume between 30 – 80 mL as calculated by the ABC/2 method
  • Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the actual time of onset is unclear, then the onset will be considered the time that the subject was last known to be well. (Treatment <8 hours is desired when possible)
  • Glasgow Coma Score (GCS) 5 - 14
  • Historical Modified Rankin Score 0 or 1

Exclusion Criteria:

  • Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging
  • NIHSS < 5
  • Bilateral fixed dilated pupils
  • Extensor motor posturing
  • Intraventricular extension of the hemorrhage visually estimated to involve >50% of either of the lateral ventricles
  • Primary thalamic ICH
  • Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
  • Use of anticoagulants that cannot be rapidly reversed
  • Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
  • Uncorrected coagulopathy or known clotting disorder
  • Platelet count < 75,000, INR > 1.4 after correction
  • Patients requiring long-term anti-coagulation that needs to be initiated < 5 days from index ICH
  • End stage renal disease
  • Patients with a mechanical heart valve
  • End-stage liver disease
  • History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal
  • Known life-expectancy of less than 6 months
  • No reasonable expectation of recovery, DNR, or comfort measures only prior to randomization
  • Participation in a concurrent interventional medical investigation or clinical trial. Patients in noninterventional/observational studies are eligible
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent
  • Homelessness or inability to meet follow up requirements

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Kaisorn Chaichana, M.D.

Closed for enrollment

More information

Publications

  • Subcortical injury resulting from conventional surgical management of intracranial hemorrhage may counteract the potential benefits of hematoma evacuation. Read More on PubMed
  • In recent decades, the surgical treatment of intracerebral hemorrhage (ICH) has become a focus of scientific inquest. This effort has been led by an international group of neurologists and neurosurgeons with the goal of studying functional recovery and developing new surgical techniques to facilitate improved clinical outcomes. Currently, the two most pressing ICH investigational goals are (1) early blood pressure control, and (2) safe hematoma volume reduction. Achieving these goals would support decision-making, level-of-care choices, and the global research strategy of developing biologically informed treatments. Herein the authors review conventional and minimally invasive surgical approaches to spontaneous ICH, articulating the scope of the problem, recent clinical trials, management issues, and relevant questions for future research. The authors propose that strategies using minimally invasive techniques including clot aspiration with stereotactic guidance may give better results with improved clinical outcomes compared with standard open surgical approaches. Read More on PubMed
  • Background and Importance. Ruptured periventricular aneurysms in patients with moyamoya disease represent challenging pathologies. The most common methods of treatment include endovascular embolization and microsurgical clipping. However, rare cases arise in which the location and anatomy of the aneurysm make these treatment modalities particularly challenging. Clinical Presentation. We report a case of a 34-year-old female with moyamoya disease who presented with intraventricular hemorrhage. CT angiography and digital subtraction angiography revealed an aneurysm located in the wall of the atrium of the right lateral ventricle. Distal endovascular access was not possible, and embolization risked the sacrifice of arteries supplying critical brain parenchyma. Using the BrainPath endoport system, the aneurysm was able to be accessed. Since the fusiform architecture of the aneurysm prevented clip placement, the aneurysm was ligated with electrocautery. Conclusion. We demonstrate the feasibility of endoport-assisted approach for minimally invasive access and treatment of uncommon, distally located aneurysms. Read More on PubMed
  • Traumatic brain injury (TBI) is a major public health problem worldwide that affects all age groups. In the United States alone, there are approximately 50,000 deaths from severe traumatic brain injuries each year. In most studies, about 40 % of severe TBI have associated traumatic intracerebral hemorrhages (tICHs). The surgical treatment of tICH is debated largely because of its invasive nature, particularly in reaching deep tICHs. tICHs have a clear contribution to mass effect and exacerbate cerebral edema and ICP because of the break-down products of hemorrhage. We introduce a modification of the Mi SPACE technique (Minimally Invasive Subcortical Parafascicular Transsulcal Access for Clot Evacuation) that is applicable to tICH. In brief, this technique utilizes a trans-sulcal, stereotactic-guided technique in which a specially designed cannula is used to introduce a 13.5-mm-diameter tube into the epicenter of the tICH. We identified eight tICHs that were treated entirely or in part with the modified Mi SPACE technique during the time period from August 15, 2014 to December 15, 2014. This modified technique was readily deployed safely and efficaciously with significant removal of the tICH as demonstrated by postoperative CT scans. The removal of tICH using this minimally invasive technique may help with the control of ICP and cerebral edema. Read More on PubMed
  • The aim of this retrospective study is to report our initial experience with endoport-assisted microsurgical evacuation (EAME) of intracerebral hemorrhages (ICH). Neurosurgical intervention has not been shown to significantly improve patient outcomes after spontaneous ICH. Minimally invasive technologies, such as endoport systems, may offer a better risk to benefit profile for ICH evacuation than conventional approaches. We performed a retrospective review of all patients who underwent EAME of ICH from January 2013 to February 2015 using the BrainPath endoport system (NICO, Indianapolis, IN, USA). The baseline and follow-up patient and ICH characteristics were analyzed. Of the 11 patients included for analysis, seven were women (64%), and the median age was 65 years (range: 23-84). The ICH was supratentorial in nine patients (82%), and the median ICH score was 2 (range: 1-4). The median preoperative and postoperative ICH volumes were 51 cm(3) (range: 8-168) and 10 cm(3) (range: 0.4-59), respectively, with a median reduction in ICH volume of 87% (range: 38-99). The median preoperative and postoperative amounts of midline shift were 6.7 mm (range: 4.9-14.3) and 3.7 mm (range: 2.2-8.9), respectively, with a median reduction in midline shift of 38% (range: 18-61). At the 90 day follow-up, four patients (36%) were functionally independent (modified Rankin Scale 0-2). Four patients had ICH-related mortalities (36%). EAME appears to be a safe and effective treatment option for ICH. Further studies are necessary to assess the comparative effectiveness of EAME in relation to medical therapy or other interventional techniques, for the management of ICH patients. Read More on PubMed
  • We describe the technical nuances of a minimally invasive anterior skull base approach for microsurgical evacuation of a large basal ganglia hematoma through an endoport. Patients who suffer from large spontaneous intracerebral hemorrhages (ICH) of the basal ganglia have a very poor prognosis. However, the benefit of surgery for the management of ICH is controversial. The development of endoport technology has allowed for minimally invasive access to subcortical lesions, and may offer unique advantages over conventional surgical techniques due to less disruption of the overlying cortex and white matter fiber tracts. A 77-year-old man presented with a hypertensive ICH of the right putamen, measuring 9 cm in maximal diameter and 168 cm(3) in volume. We planned an endoport trajectory through the long axis of the hematoma using frameless stereotactic neuronavigation. In order to access the optimal cortical entry point at the lateral aspect of the basal frontal lobe, a miniature modified orbitozygomatic skull base craniotomy was performed through an incision along the superior border of the right eyebrow. Using the BrainPath endoport system (NICO, Indianapolis, IN, USA), the putaminal hematoma was successfully evacuated, resulting in an 87% postoperative reduction in ICH volume. Thus, we show that, in appropriately selected cases, endoport-assisted microsurgery is safe and effective for the evacuation of large ICH. Furthermore, minimally invasive anterior skull base approaches can be employed to expand the therapeutic potential of endoport-assisted approaches to include subcortical lesions, such as hematomas of the basal ganglia. Read More on PubMed
  • Background. Spontaneous intracerebral hemorrhage (ICH) is common and causes significant mortality and morbidity. To date, optimal medical and surgical intervention remains uncertain. A lack of definitive benefit for operative management may be attributable to adverse surgical effect, collateral tissue injury. This is particularly relevant for ICH in dominant, eloquent cortex. Minimally invasive surgery (MIS) offers the potential advantage of reduced collateral damage. MIS utilizing a parafascicular approach has demonstrated such benefit for intracranial tumor resection. Methods. We present a case of dominant hemisphere spontaneous ICH evacuated via the minimally invasive subcortical parafascicular transsulcal access clot evacuation (Mi SPACE) model. We use this report to introduce Mi SPACE and to examine the application of this novel MIS paradigm. Case Presentation. The featured patient presented with a left temporal ICH and severe global aphasia. The hematoma was evacuated via the Mi SPACE approach. Postoperative reassessments showed significant improvement. At two months, bedside language testing was normal. MRI tractography confirmed limited collateral injury. Conclusions. This case illustrates successful application of the Mi SPACE model to ICH in dominant, eloquent cortex and subcortical regions. MRI tractography illustrates collateral tissue preservation. Safety and feasibility studies are required to further assess this promising new therapeutic paradigm. Read More on PubMed

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions