NCT02920645

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 26, 2016

Last Update Submit

September 29, 2016

Conditions

Intracerebral HemorrhageArterio-venous Malformation

Keywords

ICHAVMintracerebral hemorrhagearterio-venous malformationAVICH

Outcome Measures

Primary Outcomes (1)

  • neurological long-term outcome (modified Ranking Scale, mRS)

    up to 3 years at last follow-up

Secondary Outcomes (2)

  • neurological outcome (modified Ranking Scale, mRS)

    3 months after ICH

  • neurological outcome (modified Ranking Scale, mRS)

    1 year after ICH

Study Arms (1)

AVM-related ICH patients

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

Other: AVM-related ICH

Interventions

AVM-related ICHOTHER
AVM-related ICH patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27150647RESULT

  • 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.

    PMID: 28986471DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan-Karl Burkhardt, MD

    Department of Neurosurgery, University Hospital Zurich, University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 30, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share