Multicenter Validation of the AVICH Score

Intracerebral Hemorrhage Clinical Trial

— AVICH  

Official title:

Multicenter Validation of the AVICH Score

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02920645
• Other study ID #: AVICH-V1.1
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 26, 2016
• Last updated: September 29, 2016
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arterio-venous Malformation
• Arteriovenous Malformations
• Cerebral Hemorrhage
• Congenital Abnormalities
• Hemangioma
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Other:
• AVM-related ICH

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurological long-term outcome (modified Ranking Scale, mRS)		up to 3 years at last follow-up	No
Secondary	neurological outcome (modified Ranking Scale, mRS)		3 months after ICH	No
Secondary	neurological outcome (modified Ranking Scale, mRS)		1 year after ICH	No