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Multicenter Validation of the AVICH Score (AVICH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02920645
Recruitment Status : Unknown
Verified September 2016 by University of Zurich.
Recruitment status was:  Enrolling by invitation
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.

Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.

Multicentre validation study

Key inclusion criteria:

  • All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
  • Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.

Key exclusion criteria:

  • incomplete data set
  • AVM Patients with only subarachnoid hemorrhage (SAH) or IVH and no ICH

Condition or disease Intervention/treatment
Intracerebral Hemorrhage Arterio-venous Malformation Other: AVM-related ICH

Detailed Description:

Intracerebral hemorrhage (ICH) is the most common life threatening presentation of brain arteriovenous malformations (AVMs). Several AVM grading systems are available for presurgical risk assessment to help selecting patients for surgery. The most widely accepted and classic grading system is the Spetzler-Martin grading system; however, the recently introduced and externally validated supplemented Spetzler-Martin system seems to have an even better predictive accuracy. The pathophysiology of AVM-related ICH and spontaneous ICH is completely different. It is well known that clinical outcome in patients suffering spontaneous ICH is worse compared with patient outcome after AVM-related ICH. For spontaneous ICH, not related to AVM, several scoring systems exist to predict patient outcome. The most commonly used system is the ICH score. The available ICH scoring systems may not predict outcome in patients with hemorrhage caused by AVM rupture with the highest accuracy possible. Therefore, we examined a new scoring system called the AVM-related ICH score (AVICH score), which predicts patient outcome in the acute setting of AVM rupture. This scoring system is a special adaptation of the supplemented Spetzler-Martin grading system designed for patients presenting with hemorrhage, which includes additional clinical and radiographic information. Based on the area under the receiver operating characteristics curve (AUROC) analysis in this single center analysis, the AVICH score predicts outcome of patients with ruptured AVM and associated ICH better than the ICH score, the Spetzler-Martin, or the supplemented Spetzler-Martin grading system. An external validation is needed before the AVICH score is tested in a prospective multicenter cohort.

The primary objective of this multicenter study is to validate the AVICH score in terms of patient outcome prediction in AVM patients with associated ICH.

Secondary objectives are the impact of pretreatment of the AVICH score. Patients outcome is measured using the modified Rankin Scale (mRS) and are grouped in favorable (mRS score, 0-2) and unfavourable (mRS score, 3-6) outcome at last follow-up (LFU). The following parameters, which are part of the AVICH score, will be compared between the 2 groups: ICH score including age, Glasgow Coma Scale (GCS) score, haemorrhage volume, presence of intraventricular hemorrhage (IVH), and localization of the ICH. Spetzler-Martin grade including AVM size, eloquent location, and venous drainage, as well as the Lawton-Young grade, including age, presence of ruptured AVM, and the nidus structure. In addition pre-/postruptured treatment modalities, including embolization, radiotherapy, surgery or no treatment will be analysed. Outcome (mRS) at 3 months, at 1 year, and at LFU will be compared.

Key inclusion criteria:

  • All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
  • Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.

Key exclusion criteria:

  • incomplete data set
  • AVM Patients with only SAH or IVH and no ICH

September, 1, 2016 - September, 30, 2016

  • individual ethical approval each center (if needed)
  • data collection (n = approximately 30/center)

November, 1, 2016 - November, 31, 2016

- data analysis (Zurich)

Study Design
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Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Multicenter Validation of the AVICH Score
Study Start Date : September 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Group/Cohort Intervention/treatment
AVM-related ICH patients
patients that suffered intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM)
 Other: AVM-related ICH


Outcome Measures
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Primary Outcome Measures :
  1. neurological long-term outcome (modified Ranking Scale, mRS) [ Time Frame: up to 3 years at last follow-up ]

Secondary Outcome Measures :
  1. neurological outcome (modified Ranking Scale, mRS) [ Time Frame: 3 months after ICH ]
  2. neurological outcome (modified Ranking Scale, mRS) [ Time Frame: 1 year after ICH ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients that suffered from intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM)
Criteria

Inclusion Criteria:

  • All patients with ICH associated AVMs and a modified Rankin Scale <2 (so 0-1) before hemorrhage
  • Pretreatment (embolization, radiosurgery, surgery) before ICH is not an exclusion criteria.

Exclusion Criteria:

  • incomplete data set
  • AVM Patients with only SAH or IVH and no ICH
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920645


Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Jan-Karl Burkhardt, MD Department of Neurosurgery, University Hospital Zurich, University of Zurich
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02920645    
Other Study ID Numbers: AVICH-V1.1
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
ICH
AVM
intracerebral hemorrhage
arterio-venous malformation
AVICH
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Hemorrhage
Arteriovenous Malformations
Congenital Abnormalities
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities