MedDataX Logo

Multicenter Validation of the AVICH Score

NCT ID: NCT02920645

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracerebral Hemorrhage Arterio-venous Malformation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ICH AVM intracerebral hemorrhage arterio-venous malformation AVICH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AVM-related ICH patients

patients that suffered intracerebral hemorrhage (ICH) due to a ruptured artery-venous malformation (AVM)

AVM-related ICH

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AVM-related ICH

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patients with ICH associated AVMs and a modified Rankin Scale \<2 (so 0-1) before hemorrhage

Exclusion Criteria

* incomplete data set
* AVM Patients with only SAH or IVH and no ICH
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan-Karl Burkhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital Zurich, University of Zurich

References

Explore related publications, articles, or registry entries linked to this study.

Neidert MC, Lawton MT, Mader M, Seifert B, Valavanis A, Regli L, Bozinov O, Burkhardt JK. The AVICH Score: A Novel Grading System to Predict Clinical Outcome in Arteriovenous Malformation-Related Intracerebral Hemorrhage. World Neurosurg. 2016 Aug;92:292-297. doi: 10.1016/j.wneu.2016.04.080. Epub 2016 May 2.

Reference Type RESULT
PMID: 27150647 (View on PubMed)

Neidert MC, Lawton MT, Kim LJ, Nerva JD, Kurisu K, Ikawa F, Konczalla J, Dinc N, Seifert V, Habdank-Kolaczkowski J, Hatano T, Hayase M, Podlesek D, Schackert G, Wanet T, Glasker S, Griessenauer CJ, Ogilvy CS, Kneist A, Sure U, Seifert B, Regli L, Bozinov O, Burkhardt JK. International multicentre validation of the arteriovenous malformation-related intracerebral haemorrhage (AVICH) score. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1163-1166. doi: 10.1136/jnnp-2017-316259. Epub 2017 Oct 6.

Reference Type DERIVED
PMID: 28986471 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AVICH-V1.1

Identifier Type: -

Identifier Source: org_study_id